PPMI Data Overview. Christopher S. Coffey The University of Iowa. PPMI Investigators Meeting May 13-14, 2015 New York, NY
|
|
- Ethelbert Lambert
- 6 years ago
- Views:
Transcription
1 PPMI Data Overview Christopher S. Coffey The University of Iowa PPMI Investigators Meeting May 13-14, 2015 New York, NY
2 Source of data for this presentation: Information comes from: Tables produced for CSOC report Tables produced for monthly review by steering committee Additional data requests OVERVIEW All data comes from a data freeze based on data obtained from the LONI website on 05/01/
3 ENROLLMENT GROUP Consented Enrolled Withdrawn Active Complete PD Subjects Healthy Controls SWEDD Subjects Prodromal -yposmic Prodromal-RBD LRRK2 PD Cohort LRRK2 UA Cohort SNCA PD Cohort SNCA UA Cohort PD Registry UA Registry TOTAL
4 ENROLLMENT - Prodromal 4
5 ENROLLMENT- Genetic Cohort 5
6 GENDER/AGE DISTRIBUTION Male Female P-Value LRRK2 Cohort PD Subjects Unaffected Subjects 25 (36%) 21 (39%) 45 (64%) 33 (61%) SNCA Cohort PD Subjects Unaffected Subjects 3 (38%) 0 (0%) 5 (62%) 2 (100%) 0.48 N/A LRRK2 Registry PD Subjects Unaffected Subjects 34 (53%) 22 (49%) 30 (47%) 23 (51%) SNCA Registry PD Subjects Unaffected Subjects 1 (33%) 0 (0%) 2 (67%) 1 (100%) 0.56 N/A 6
7 BASELINE CHARACT. (PRODROMAL) Hyposmic Subjects (N = 26) RBD Subjects (N = 38) Males 18 (69%) 32 (84%) Age (mean) Education < 13 yrs 3 (12%) 14 (37%) Hispanic/Latino 2 (8%) 18 (47%) Caucasian 23 (88%) 34 (89%) Family Hx of PD - First Degree - Other - None 5 (19%) 0 (0%) 21 (81%) 3 (8%) 0 (0%) 35 (92%) 7
8 BASELINE CHARACT. (PRODROMAL) MDS-UPDRS Score - Total Score - Part I - Part II - Part III (Motor Exam) Hoehn & Yahr - Stage 0 - Stage 1 - Stage 2-5 Hyosmic Subjects (N = 26) 9.9 (7.5) 5.0 (3.5) 2.1 (2.4) 2.9 (3.6) 23 (88%) 2 (8%) 1 (4%) RBD Subjects (N = 38) 14.0 (7.7) 7.2 (4.0) 2.1 (2.6) 4.6 (3.8) 37 (100%) 0 (0%) 0 (0%) Modified Schwab 99.2 (3.9) 98.6 (3.3) Duration of Disease (months) NOTES: Hoehn & Yahr missing for one RBD Subject N/A N/A 8
9 BASELINE CHARACT. (PRODROMAL) Hyposmic Subjects (N = 26) RBD Subjects (N = 38) MOCA Total Score 27.3 (1.7) 25.4 (4.1) GDS Total Score 1.5 (1.5) 2.8 (2.6) SCOPA AUT Score 9.2 (5.0) 14.9 (8.3) STAS 54.9 (12.1) 68.8 (18.3) QUIP 0.3 (0.6) 0.5 (0.7) UPSIT Raw Score 15.4 (5.6) 18.2 (7.1) Epworth Sleep. Scale (Sleepy = 10 or above) REM Sleep Disorder (Positive = 5 or above) 2 (8%) 12 (32%) 11 (42%) 33 (87%) 9
10 BASELINE CHARACT. (PRODROMAL) Hyposmic Subjects (N = 26) RBD Subjects (N = 38) Caudate 2.5 (0.53) 1.9 (0.52) Putamen 1.4 (0.30) 1.1 (0.31) NOTES: For Prodromal Subjects, mean of left and right values are used for all analyses. 10
11 BASELINE CHARACT. (GENETIC COHORT) LRRK2 PD Subjects (N = 70) SNCA PD Subjects (N = 8) Unaffected Subjects (N = 56) Males 25 (36%) 3 (39%) 21 (38%) Age (mean) Education < 13 yrs 24 (34%) 5 (63%) 22 (39%) Hispanic/Latino 28 (40%) 0 (0%) 7 (13%) Caucasian 57 (81%) 8 (100%) 52 (93%) Family Hx of PD - First Degree - Other - None - Missing 25 (36%) 8 (11%) 20 (29%) 17 (24%) 8 (100%) 0 (0%) 0 (0%) 0 (0%) 27 (48%) 4 (7%) 1 (2%) 24 (43%) 11
12 BASELINE CHARACT. (GENETIC COHORT) MDS-UPDRS Score - Total Score - Part I - Part II - Part III (Motor Exam) Hoehn & Yahr - Stage 0 - Stage 1 - Stage Missing LRRK2 PD Subjects (N = 70) 37.3 (18.8) 8.3 (5.8) 7.4 (6.4) 21.7 (10.4) 0 (0%) 11 (16%) 52 (75%) 7 (9%) SNCA PD Subjects (N = 8) 58.6 (36.4) 12.3 (8.4) 13.3 (6.3) 33.7 (24.6) 0 (0%) 1 (13%) 6 (75%) 1 (13%) Unaffected Subjects (N = 56) 6.7 (5.4) 3.6 (3.3) 0.6 (1.8) 2.5 (3.8) 47 (84%) 2 (4%) 3 (5%) 4 (7%) Modified Schwab 91.1 (9.8) 73.8 (11.9) 99.6 (1.9) Duration of Disease (months) 34 (25.3) 52 (11.3) N/A 12
13 BASELINE CHARACT. (GENETIC COHORT) LRRK2 PD Subjects (N = 70) SNCA PD Subjects (N = 8) Unaffected Subjects (N = 56) MOCA Total Score 26.0 (3.3) 24.1 (5.6) 26.4 (2.6) GDS Total Score 3.6 (3.3) 5.7 (3.4) 1.9 (2.2) SCOPA AUT Score 13.6 (8.8) 15.6 (12.4) 8.8 (6.8) STAS 73.6 (20.5) 91.5 (16.2) 61.8 (15.7) QUIP 0.5 (0.7) 2.0 (1.2) 0.4 (0.8) UPSIT Raw Score 24.9 (7.1) 11.3 (2.5) 32.1 (4.1) Epworth Sleep. Scale (Sleepy = 10 or above) REM Sleep Disorder (Positive = 5 or above) 19 (27%) 3 (38%) 7 (13%) 22 (31%) 7 (88%) 11 (20%) 13
14 BASELINE CHARACT. (GENETIC COHORT) LRRK2 PD Subjects (N = 70) SNCA PD Subjects (N = 8) Unaffected Subjects (N = 56) Contralateral Caudate 1.7 (0.57) 0.7 (0.13) 3.0 (0.66) Ipsilateral Caudate 2.0 (0.67) 0.9 (0.01) 3.0 (0.66) Contralateral Putamen 0.7 (0.29) 0.3 (0.01) 2.1 (0.55) Ipsilateral Putamen 0.8 (0.34) 0.4 (0.14) 2.1 (0.55) NOTES: For Unaffected Subjects and PD subjects with symmetrical presentation, mean of left and right values are used for all analyses. DaTSCAN at baseline missing for 45 LRRK2 PD subjects, 6 SNCA PD subjects, & 18 unaffected subjects. 14
15 VISIT COMPLIANCE 6 Months # Expected (% Seen) 1 Year # Expected (% Seen) 2 Year # Expected (% Seen) 3 Year # Expected (% Seen) 4 Year # Expected (% Seen) PD 414 (94%) 409 (96%) 367 (92%) 175 (89%) 35 (91%) HC 192 (95%) 189 (98%) 170 (95%) 134 (94%) 29 (83%) SWEDD 62 (89%) 62 (94%) 56 (88%) N/A N/A Hyposmic 12 (92%) 5 (100%) N/A N/A N/A RBD 23 (96%) 5 (80%) N/A N/A N/A Genetic Cohort PD Genetic Cohort UA 40 (85%) 4 (75%) N/A N/A N/A 32 (50%) 10 (80%) N/A N/A N/A 15
16 LUMBAR PUNCTURE COMPLETENESS Baseline # Expected (% Comp) 6 Months # Expected (% Comp) 1 Year #Expected (% Comp) 2 Year #Expected (% Comp) 3 Year #Expected (% Comp) 4 Year #Expected (% Comp) PD 423 (98%) 391 (88%) 393 (84%) 336 (82%) 155 (81%) 32 (72%) HC 196 (97%) 183 (87%) 185 (84%) 161 (80%) 126 (80%) 24 (79%) SWEDD 64 (92%) 55 (85%) 58 (83%) 49 (76%) N/A N/A Hyposmic 22 (91%) 10 (70%) 5 (60%) N/A N/A N/A RBD 37 (92%) 22 (91%) 4 (75%) N/A N/A N/A Genetic Cohort -PD 69 (90%) 3 (100%) N/A N/A N/A N/A Genetic Cohort UA 54 (93%) 8 (50%) N/A N/A N/A N/A 16
17 DATSCAN COMPLETENESS Baseline # Expected (% Comp) 1 Year #Expected (% Comp) 2 Year #Expected (% Comp) 4 Year #Expected (% Comp) PD 423 (99%) 394 (96%) 336 (94%) 32 (84%) HC 196 (91%) N/A N/A N/A SWEDD 64 (97%) N/A 49 (98%) N/A Hyposmic 26 (100%) 5 (100%) N/A N/A RBD 38 (100%) 4 (100%) N/A N/A Genetic Cohort PD Genetic Cohort UA 71 (89%) N/A N/A N/A 54 (93%) N/A N/A N/A 17
18 EARLY STUDY TERMINATIONS PD Subjects: 32 early study terminations 12 withdrew consent 10 due to other 4 travel distance 2 work/time demands 1 protocol violation 1 subject decided environment issues were cause of PD 1 patient decided to take anti-parkinsonian medication today 1 patient diagnosed with glioblastoma, investigator felt it was in patients best interest to withdraw from study 5 deaths 3 lost to follow-up 2 due to adverse event (headache, exasperation of PD symptoms) 18
19 EARLY STUDY TERMINATIONS Healthy Controls: 18 early study terminations 7 withdrew consent 6 due to other 2 travel distance 1 diagnosed with CIDP, does not want to continue 1 unwilling to comply with lumbar puncture 1 between baseline & v01 patient became employee at site 1 spouse too ill to continue subject participation 4 deaths 1 lost to follow-up 19
20 EARLY STUDY TERMINATIONS SWEDDs: 7 early study terminations 3 withdrew consent 2 due to other subject choice, health issues SWEDD subject, study ends at V06 2 lost to follow-up Prodromal: 1 early study termination Investigator decision Genetic Cohort: 1 early study termination other - meningioma 20
21 REPORTABLE EVENTS PD Subjects: 421 reportable events (378 subjects) 355 starting PD meds 32 early withdrawals 23 starting another study 5 deaths 2 changing diagnosis 2 SAE 21
22 REPORTABLE EVENTS Healthy Controls: 31 reportable events (27 subjects) 18 early withdrawals 6 change of diagnosis 4 deaths 1 each for starting another study, SAE, pregnancy SWEDD Subjects: 44 reportable events (37 subjects) 26 change of diagnosis 9 starting PD meds 7 early withdrawals 1 each for starting another study, SAE 22
23 REPORTABLE EVENTS Prodromal Cohort: 3 reportable events (3 subjects) 1 early termination 1 change of diagnosis 1 death Genetic Cohort: 1 reportable event Death 23
24 ADVERSE EVENTS PD vs HC Subjects with an AE: PD Subjects 152/423 (36%) Healthy Controls 84/196 (43%) RR = 0.84, 95% CI: (0.68, 1.03) Subjects with an LP-related AE: PD Subjects 137/423 (32%) Healthy Controls 78/196 (40%) RR = 0.81, 95% CI: (0.65, 1.01) Subjects with a DaTSCAN-related AE: PD Subjects 11/423 (3%) Healthy Controls 4/196 (2%) RR = 1.27, 95% CI: (0.41, 3.94) 24
25 ADVERSE EVENTS PD vs. SWEDD Subjects with an AE: PD Subjects 152/423 (36%) SWEDD Subjects 33/64 (52%) RR = 0.70, 95% CI: (0.53, 0.92) Subjects with an LP-related AE: PD Subjects 137/423 (32%) SWEDD Subjects 27/64 (42%) RR = 0.77, 95% CI: (0.56, 1.06) Subjects with a DaTSCAN-related AE: PD Subjects 11/423 (3%) SWEDD Subjects 4/64 (6%) RR = 0.42, 95% CI: (0.14, 1.28) Increased reporting of Back Pain in SWEDD group (4% vs. 11% of subjects): RR = 0.32, 95% CI: (0.14, 0.75) 25
26 SERIOUS ADVERSE EVENTS PD Subjects: 4 SAEs (in 4 subjects) Death Operation Due to Halux Valgus Surgery of Arthrosis Left Knee Fracture in Hip Healthy Controls: 1 SAE (in 1 subject) Tractor Accident SWEDD Subjects: 1 SAE (in 1 subject) 1 Confusional State None related to LP or DaTSCAN. 26
27 TIME TO START PD MEDICATIONS 27
28 TD/PIGD OVER TIME 381 Subjects with a Baseline & 1 Year Assessment: Of the 266 Subjects TD at Baseline: 215 (81%) also TD at 1 Year 21 (8%) Indeterminate at 1 Year 30 (11%) PIGD at 1 Year Of the 72 Subjects PIGD at Baseline: 18 (25%) TD at 1 Year 7 (10%) Indeterminate at 1 Year 47 (65%) also PIGD at 1 Year 28
29 MDS-UPDRS OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline Month 6 Year 1 Year 2 Year 3 Year 4 PD 32 (422) (7, 72) 39 (388) (4, 94) 39 (378) (6, 113) 43 (333) (10, 96) 48 (154) (13, 121) 55 (37) (20, 100) HC 5 (195) (0, 20) 5 (185) (0, 25) 5 (162) (0, 26) 6 (127) (0, 24) 5 (22) (0, 25) SWEDD 28 (64) (4, 91) 32 (55) (4, 105) 30 (57) (3, 78) 33 (50) (3, 122) N/A N/A 29
30 MDS-UPDRS OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline Month 6 Year 1 Year 2 Year 3 Year 4 Untreated 32 (422) (7, 72) 40 (374) (4, 94) 39 (166) (13, 113) 40 (59) (14, 76) 39 (22) (13, 74) N/A ON Scores N/A N/A 34 (134) (4, 79) 37 (169) (5, 80) 44 (74) (8, 109) 51 (23) (22, 89) OFF Scores N/A 33 (29) (11, 61) 39 (216) (6, 89) 43 (274) (10, 96) 49 (132) (13, 121) 57 (35) (24, 100) 30
31 MDS-UPDRS OVER TIME Analysis performed to assess change from baseline to year 1 in MDS-UPDRS Total Score (untreated or OFF). Following correlated with greater increase in year one: Lower baseline MDS-UPDRS scores Not starting ST therapy within the first year Lower contralateral putamen at baseline Higher T-Tau at baseline Lower alpha-synuclein at baseline 31
32 DATSCAN OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline PD 0.7 (419) (0.1, 2.2) HC 2.2 (193) (0.6, 3.9) SWEDD 2.1 (62) (0.8, 3.2) Year (348) (0.1, 1.8) N/A 1.8 (26) (0.8, 2.4) Year (169) (0.2, 1.5) N/A N/A 32
33 DATSCAN OVER TIME Analysis performed to assess change from baseline to year 1 in Contralateral Putaman from DAT imaging. Following correlated with greater increase in year one: Lower baseline contralateral putamen Lower baseline SCOPA-AUT score Higher UPSIT raw score at baseline 33
34 SCOPA-AUT OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline Month 6 Year 1 Year 2 Year 3 Year 4 PD 10 (423) (0, 39) 10 (403) (0, 40) 11 (395) (0, 45) 12 (344) (0, 42) 13 (157) (0, 31) 15 (39) (3, 34) HC 6 (195) (0, 20) N/A 6 (185) (0, 22) 6 (162) (0, 22) 7 (128) (0, 28) 6 (22) (1, 17) SWEDD 14 (64) (2, 44) 15 (55) (0, 44) 14 (58) (2, 42) 13 (51) (0, 41) N/A 34
35 MOCA OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline Median (N) Year 1 Median (N) Year 2 Median (N) Year 3 Median (N) Year 4 Median (N) PD 27 (423) (17, 30) 26 (392) (15, 30) 26 (340) (14, 30) 26 (158) (13, 30) 26 (38) (13, 30) HC 28 (196) (26, 30) 27 (185) (20, 30) 27 (162) (21, 30) 27 (128) (19, 30) 28 (22) (24, 30) SWEDD 27 (64) (17, 30) 26 (58) (20, 30) 26 (50) (16, 30) N/A 35
36 ALPHA-SYNUCLEIN OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline N Mean (SD) PD (786) HC (1089) SWEDD (1027) Month 6 N Mean (SD) (741) (917) (876) Year 1 N Mean (SD) (805) (956) (642) 36
37 T-TAU OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline N Mean (SD) PD (18.3) HC (27.2) SWEDD (23.0) Month 6 N Mean (SD) (16.9) (23.8) (29.0) Year 1 N Mean (SD) (17.4) (27.0) (27.4) 37
38 P-TAU OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline N Mean (SD) Month 6 N Mean (SD) Year 1 N Mean (SD) PD (10.1) (9.8) (11.7) HC (11.7) (8.4) (12.6) SWEDD (11.8) (15.1) (11.9) 38
39 A-BETA OVER TIME Report generated on data submitted as of: 13Apr2015 Baseline N Mean (SD) Month 6 N Mean (SD) Year 1 N Mean (SD) PD (100.4) (98.3) (103.6) HC (113.6) (98.6) (105.3) SWEDD (106.9) (81.0) (75.5) 39
PPMI Status Update. Ken Marek. WW-ADNI July 11, 2013
PPMI Status Update Ken Marek WW-ADNI July 11, 2013 Disclosure Co-founder on Molecular Neuroimaging LLC PET and SPECT imaging services Consultant BMS, GEHC, Lilly, Merck, Navidea, Piramal Pfizer, Sanofi,
More informationLearnings from Parkinson s disease: Critical role of Biomarkers in successful drug development
Learnings from Parkinson s disease: Critical role of Biomarkers in successful drug development Ken Marek Coalition Against Major Diseases and FDA 2014 Annual Scientific Workshop Oct 2014 Disclosure Co-founder
More informationPARKINSON S PROGRESSION MARKERS INITIATIVE. PPMI 2018 Annual Investigators Meeting PPMI Data Blitz
PARKINSON S PROGRESSION MARKERS INITIATIVE PPMI 2018 Annual Investigators Meeting PPMI Data Blitz OVERVIEW Longitudinal Change of Clinical and Biological Measures in Early PD Presented by Andrew Siderowf
More informationThe Parkinson Progression Marker Initiative (PPMI) WW-ADNI July
The Parkinson Progression Marker Initiative (PPMI) WW-ADNI July 15 2011 Rationale for PPMI: Challenges of disease-modifying trials Disease modifying PD therapeutics remain a major unmet need A major obstacle
More informationPPMI Genetics Cohorts
PPMI Genetics Cohorts Ken Marek PPMI Genetics Kickoff Sept 16, 2013 New York, NY PPMI Genetic Cohort/Registry Symptomatic Neuron Function Prodromal P-PPMI Gen P-PPMI PPMI Diagnosis PPMI- Gen 2 PPMI-Genetics
More informationNon-motor subtypes of Early Parkinson Disease in the Parkinson s Progression Markers Initiative
Non-motor subtypes of Early Parkinson Disease in the Parkinson s Progression Markers Initiative Samay Jain, MD MSc Seo Young Park, PhD University of Pittsburgh Department of Neurology and Center for Research
More informationPPMI Cognitive-Behavioral Working Group. Daniel Weintraub, MD
PPMI Cognitive-Behavioral Working Group Daniel Weintraub, MD PPMI Annual Meeting - May 6-7, 2014 Membership Daniel Weintraub WG Chair Tanya Simuni Steering Committee Shirley Lasch IND Chris Coffey, Chelsea
More informationChange the size of any window by dragging the lower left corner. Use controls
Early Detection of Parkinson s s Disease Change the size of any window by dragging the lower left corner. Use controls in top right corner to close or maximize each window Use text box at bottom left to
More informationPARKINSON S PROGRESSION MARKERS INITIATIVE. PPMI 2016 ANNUUAL INVESTIGATORS MEETING May 4-5
PARKINSON S PROGRESSION MARKERS INITIATIVE PPMI 2016 ANNUUAL INVESTIGATORS MEETING May 4-5 PPMI Update Ken Marek PPMI Annual Meeting May 4, 2016 New York, NY PD patient MAY 2011 67 yo right handed WF in
More informationClinical Trial Glossary
Clinical Trial Glossary Adverse event An unfavorable change in health that can occur during a clinical trial or study or within a certain time period after. These can range from mild (e.g., nausea) to
More informationPPMI Imaging Core Update
PPMI Imaging Core Update John Seibyl, MD 7 May 2013 PPMI Imaging Core Update 1. PPMI status update: enrollment, demographics, compliance 2. DAT analyses -baseline and initial progression data -phantom
More informationParkinson s Progression Markers Initiative (PPMI) John Q. Trojanowski, M.D., Ph.D.
Parkinson s Progression Markers Initiative (PPMI) John Q. Trojanowski, M.D., Ph.D. Parkinson s Progression Marker Initiative NINDS Udall Center of Excellence For Parkinson s Disease Research, NIA Alzheimer
More informationThe Safety of Lumbar Punctures. Samuel Frank, MD
The Safety of Lumbar Punctures Samuel Frank, MD Risk Factors Modifiable Non-Modifiable Gauge of spinal needle Needle shape Bevel orientation & angle of insertion Stylet replacement Operator experience
More informationUpdate on functional brain imaging in Movement Disorders
Update on functional brain imaging in Movement Disorders Mario Masellis, MSc, MD, FRCPC, PhD Assistant Professor & Clinician-Scientist Sunnybrook Health Sciences Centre University of Toronto 53 rd CNSF
More informationImaging biomarkers for Parkinson s disease
3 rd Congress of the European Academy of Neurology Amsterdam, The Netherlands, June 24 27, 2017 Teaching Course 6 MDS-ES/EAN: Neuroimaging in movement disorders - Level 2 Imaging biomarkers for Parkinson
More informationRole of Biomarkers and Clinical Markers in patient selection and monitoring in PD. Ken Marek Institute for Neurodegenerative Disorders Feb 22, 2018
Role of Biomarkers and Clinical Markers in patient selection and monitoring in PD Ken Marek Institute for Neurodegenerative Disorders Feb 22, 2018 Disclosure Co-founder of Molecular Neuroimaging LLC PET
More informationIan McKeith MD, F Med Sci, Professor of Old Age Psychiatry, Newcastle University
Ian McKeith MD, F Med Sci, Professor of Old Age Psychiatry, Newcastle University Design of trials in DLB and PDD What has been learnt from previous trials in these indications and other dementias? Overview
More informationPPMI. Ken Marek. PPMI Annual Meeting May 2, 2018 New York, NY
PPMI Ken Marek PPMI Annual Meeting May 2, 2018 New York, NY 67 yo right handed WF in excellent general health History 6 month history of poor tennis play Note 1-2 years mild constipation 2 months intermittent
More informationPPMI Status Update. Ken Marek. PPMI Investigators Meeting May 7, 2013 New York, NY
PPMI Status Update Ken Marek PPMI Investigators Meeting May 7, 2013 New York, NY 67 yo right handed WF in excellent general health History 6 month history of poor tennis play Note 1-2 years mild constipation
More informationParkinson s Disease in the Elderly A Physicians perspective. Dr John Coyle
Parkinson s Disease in the Elderly A Physicians perspective Dr John Coyle Overview Introduction Epidemiology and aetiology Pathogenesis Diagnosis and clinical features Treatment Psychological issues/ non
More informationPPMI Update. Ken Marek. PPMI Annual Meeting May 13, 2015 New York, NY
PPMI Update Ken Marek PPMI Annual Meeting May 13, 2015 New York, NY 67 yo right handed WF in excellent general health History 6 month history of poor tennis play Note 1-2 years mild constipation 2 months
More informationHM2008/00566/00. study and to obtain clinical experience with the use of this drug. Primary Outcome/Efficacy Variable(s): <Pharmacokinetics>
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationEarly Clinical Features of Parkinson s Disease and Related Disorders. Dr. Alastair Noyce
1 Specialist Registrar in Neurology, London Deanery Parkinson s UK Doctoral Research Fellow Project lead for PREDICT-PD Declarations Salary: Parkinson's UK, Barts and the London NHS Trust Grants: Parkinson's
More informationClinical Trial Results Database Page 1
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Therapeutic Area of Trial L-dopa induced dyskinesias in Parkinson s disease (PD-LID) Approved Indication Not approved yet for any
More informationCSF Aβ1-42 predicts cognitive impairment in de novo PD patients
CSF Aβ1-42 predicts cognitive impairment in de novo PD patients Mark Terrelonge MPH *1, Karen Marder MD MPH 1, Daniel Weintraub MD 2, Roy Alcalay MD MS 1 1 Columbia University Department of Neurology 2
More informationSponsor Novartis. Generic Drug Name AFQ056. Therapeutic Area of Trial L-dopa induced dyskinesias in Parkinson s disease (PD-LID)
Sponsor Novartis Generic Drug Name AFQ056 Therapeutic Area of Trial L-dopa induced dyskinesias in Parkinson s disease (PD-LID) Approved Indication Investigational Protocol Number CAFQ056A2223 Title 13-week,
More informationUPDATE ON RESEARCH IN PARKINSON S DISEASE
UPDATE ON RESEARCH IN PARKINSON S DISEASE Charles H. Adler, M.D., Ph.D. Professor of Neurology Mayo Clinic College of Medicine Co-Principal Investigator Arizona Parkinson s Disease Consortium Arizona Study
More informationIl ruolo di nuove tecniche di imaging per la diagnosi precoce di demenza
Parma, 23 maggio 2017 Il ruolo di nuove tecniche di imaging per la diagnosi precoce di demenza Livia Ruffini SC Medicina Nucleare Azienda Ospedaliero-Universitaria di Parma PET AND SPECT STUDIES OF THE
More informationSponsor Novartis. Generic Drug Name. NA (not existing yet) Therapeutic Area of Trial Parkinson s Disease L-dopa induced dyskinesia
Page 1 Sponsor Novartis Generic Drug Name NA (not existing yet) Therapeutic Area of Trial Parkinson s Disease L-dopa induced dyskinesia Approved Indication Investigational. Study Number CA2206 Title A
More informationFOUNDATION OF UNDERSTANDING PARKINSON S DISEASE
FOUNDATION OF UNDERSTANDING PARKINSON S DISEASE DEE SILVER M.D MOVEMENT DISORDER SPECIALIST MEDICAL DIRECTOR -- PARKINSON ASSOCIATION OF SAN DIEGO 1980 TO PRESENT SCRIPPS MEMORIAL HOSPITAL, LA JOLLA CA.
More informationPresented by Meagan Koepnick, Josh McDonald, Abby Narayan, Jared Szabo Mentored by Dr. Doorn
Presented by Meagan Koepnick, Josh McDonald, Abby Narayan, Jared Szabo Mentored by Dr. Doorn Objectives What agents do we currently have available and what do we ideally need? What biomarkers exist for
More informationUpdate on the DLB Module. ADC Directors Meeting Baltimore, MD October 14-15, 2016
Update on the DLB Module ADC Directors Meeting Baltimore, MD October 14-15, 2016 Committee Members James Galvin, Florida Atlantic University (Chair) James Leverenz Cleveland Clinic Brad Boeve Mayo Clinic,
More informationOverview of the PPMI Widespread Recruitment Initiative. Tatiana Foroud Indiana University Genetic Coordination Center (GCC)
Overview of the PPMI Widespread Recruitment Initiative Tatiana Foroud Indiana University Genetic Coordination Center (GCC) G-PPMI: Widespread Recruitment MJFF and the Genetic Coordination Core (GCC) developed
More informationDraft agreed by Scientific Advice Working Party 26 October Adopted by CHMP for release for consultation 09 November
1 2 3 20 November 2017 EMA/765041/2017 Product Development Scientific Support Department 4 Draft qualification opinion on molecular neuroimaging of 5 the dopamine transporter as biomarker to identify 6
More informationSummary of Patient < 3y at Visit 11 (90 months)
Summary of Patient < 3y at 11 (90 months) Clinician Scoring Page Direct online data entry available? Medication 378 Yes BPW 382 Yes Diagnostic Features 383 Yes UPDRS Clinician 388 Yes CISI-PD 397 Yes MoCA
More informationOverview. Overview. Parkinson s disease. Secondary Parkinsonism. Parkinsonism: Motor symptoms associated with impairment in basal ganglia circuits
Overview Overview Parkinsonism: Motor symptoms associated with impairment in basal ganglia circuits The differential diagnosis of Parkinson s disease Primary vs. Secondary Parkinsonism Proteinopathies:
More informationClinical Trial Results Posting
RD..3.2 V1. Page/Seite 1 of/von 5 CT Registry ID#: NCT2428 (ClinicalTrials.gov Identifier number) These results are supplied for informational purposes only. Prescribing decisions should be made based
More informationMoving Treatment Earlier Disease Modification in Early PD
Moving Treatment Earlier Disease Modification in Early PD Ron Postuma Montreal General Hospital McGill University Disclosures: - Grants: Fonds de la Recherche en Sante Quebec, Canadian Institute of Health
More informationDopamine Transporter Imaging With Single-Photon Emission Computed. Tomography
Dopamine Transporter Imaging With Single-Photon Emission Computed Tomography Policy Number: 6.01.54 Last Review: 9/2018 Origination: 9/2015 Next Review: 9/2019 Policy Blue Cross and Blue Shield of Kansas
More informationUpdate on the DLB Module. ADC Directors Meeting Baltimore, MD October 14-15, 2016
Update on the DLB Module ADC Directors Meeting Baltimore, MD October 14-15, 2016 Committee Members James Galvin, Florida Atlantic University Chair James Leverenz Cleveland Clinic Brad Boeve Mayo Clinic
More informationEvaluation of Parkinson s Patients and Primary Care Providers
Evaluation of Parkinson s Patients and Primary Care Providers 2018 Movement Disorders Half Day Symposium Elise Anderson MD Medical Co-Director, PBSI Movement Disorders 6/28/2018 1 Disclosures GE Speaker,
More informationDraft agreed by Scientific Advice Working Party 26 October Adopted by CHMP for release for consultation 09 November
29 May 2018 EMA/CHMP/SAWP/765041/2017 Committee for Medicinal Products for Human Use (CHMP) Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson s disease clinical
More informationBig data and Parkinson s: Exploration, analyses, data challenges and visualization
Graduate Theses and Dissertations Iowa State University Capstones, Theses and Dissertations 2017 Big data and Parkinson s: Exploration, analyses, data challenges and visualization Mahalakshmi Senthilarumugam
More informationUSING PRECISION MEDICINE TO HELP PATIENTS WITH PARKINSON S DISEASE. The Michael J. Fox Foundation for Parkinson s Research
USING PRECISION MEDICINE TO HELP PATIENTS WITH PARKINSON S DISEASE The Michael J. Fox Foundation for Parkinson s Research MJFF IS THE WORLD S LARGEST NONPROFIT FUNDER OF PD RESEARCH Our Mission We are
More informationGenetic Recruitment. Genetic Coordination Core
Genetic Recruitment Genetic Coordination Core Genetic Arms Recruit for: LRRK2: G2019S, R1441G, I2020T SNCA: A53T, G209A GBA: N370S Other mutations can be found in these genes Limited the range of mutations
More informationL ecografia cerebrale: accuratezza diagnostica Dr Patrizio Prati Neurologia CIDIMU Torino
L ecografia cerebrale: accuratezza diagnostica Dr Patrizio Prati Neurologia CIDIMU Torino Ecografia cerebrale: l accuratezza diagnostica. Lo studio NOBIS Dr Patrizio Prati Neurologia CIDIMU Torinorin Normal
More informationInformatics Core. Arthur Toga May 2014
Informatics Core Arthur Toga May 2014 Informatics Core Status Website News and Activity Data Repository News and Activity Image QC Workflows 3 New Study Cohort bar graphs PPMI Homepage PPMI New Study Cohorts
More informationBasal ganglia motor circuit
Parkinson s Disease Basal ganglia motor circuit 1 Direct pathway (gas pedal) 2 Indirect pathway (brake) To release or augment the tonic inhibition of GPi on thalamus Direct pathway There is a tonic inhibition
More informationPPMI Study CRF and Assessments
Study CRF and Assessments For Amendment-3 TAP-PD Version 2.1 This packet contains CRFs from the Clinical Trials Coordination Center (CTCC; PPMI Clinical Core). The CRF and assessment information in this
More informationNon-motor symptoms as a marker of. Michael Samuel
Non-motor symptoms as a marker of progression in Parkinson s s disease Michael Samuel London, UK 1 Definitions and their problems Non-motor symptoms as a marker of progression Non-motor symptoms (NMS)
More informationThe Parkinson s You Can t See
The Parkinson s You Can t See We principally see the motor phenomena of Parkinson's disease, but is there an early stage without visible features? Might this provide a window for disease-modifying therapy?
More informationPimavanserin Top-Line Results Phase III Parkinson s Disease Psychosis Trial (-020 Study) Creating the Next Generation of CNS Drugs
Pimavanserin Top-Line Results Phase III Parkinson s Disease Psychosis Trial (-020 Study) Creating the Next Generation of CNS Drugs Forward-Looking Statement This presentation contains forward-looking statements.
More informationIII./3.1. Movement disorders with akinetic rigid symptoms
III./3.1. Movement disorders with akinetic rigid symptoms III./3.1.1. Parkinson s disease Parkinson s disease (PD) is the second most common neurodegenerative disorder worldwide after Alzheimer s disease.
More informationSYNOPSIS THIS IS A PRINTED COPY OF AN ELECTRONIC DOCUMENT. PLEASE CHECK ITS VALIDITY BEFORE USE.
Drug product: Drug substance(s): Document No.: Edition No.: 1 Study code: Accolate Zafirlukast (ZD9188) 9188IL/0138 Date: 02 May 2007 SYNOPSIS A Multicenter, Randomized, Double-blind, -controlled, Parallel
More informationPPMI 2018 ANNUAL INVESTIGATORS MEETING May 2-3
PPMI 2018 ANNUAL INVESTIGATORS MEETING May 2-3 CAROLINE TANNER M.D., PH.D. PPMI FOUND (FOLLOW-UP OF PERSONS WITH NEUROLOGIC DISEASES) WHAT IS FOUND? FOUND is a method for long term follow-up of research
More informationWHO, WHAT, WHEN AND WHERE OF PARKINSON S DIAGNOSIS. MJFF Third Thursdays Webinar March 17, 2016
WHO, WHAT, WHEN AND WHERE OF PARKINSON S DIAGNOSIS MJFF Third Thursdays Webinar March 17, 2016 WHAT WE LL COVER TODAY How is Parkinson s misdiagnosed? How is Parkinson s diagnosed today? Can we use DaTscan
More informationGiancarlo Comi, M.D. On Behalf of the MS-LAQ-301 (ALLEGRO) Study Group. Assessment of oral laquinimod in preventing progression of Multiple Sclerosis
COMPARISON OF EARLY AND DELAYED ORAL LAQUINIMOD IN PATIENTS WITH RELAPSING- REMITTING MULTIPLE SCLEROSIS: EFFECTS ON DISABILITY PROGRESSION AT 36 MONTHS IN THE ALLEGRO TRIAL Giancarlo Comi, M.D. On Behalf
More informationImproving diagnosis of Alzheimer s disease and lewy body dementia. Brain TLC October 2018
Improving diagnosis of Alzheimer s disease and lewy body dementia Brain TLC October 2018 Plan for this discussion: Introduction to AD and LBD Why do we need to improve diagnosis? What progress has been
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationRasagiline and Rapid Symptomatic Motor Effect in Parkinson s Disease: Review of Literature
Neurol Ther (2014) 3:41 66 DOI 10.1007/s40120-013-0014-1 REVIEW Rasagiline and Rapid Symptomatic Motor Effect in Parkinson s Disease: Review of Literature Michele Pistacchi Francesco Martinello Manuela
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSleeping with PD. Jean Tsai, MD PhD September 27, 2014
Sleeping with PD Jean Tsai, MD PhD September 27, 2014 Evaluation of sleep Assessment at least annually recommended by Agency for Healthcare Research and Quality (AHRQ) of the US Dept of Health and Human
More informationUsing Resting-State Functional Connectivity of the Basal Ganglia as a Biomarker for Symptoms of Parkinson's Disease
Illinois Math and Science Academy DigitalCommons@IMSA Student Publications & Research Student Works 4-2015 Using Resting-State Functional Connectivity of the Basal Ganglia as a Biomarker for Symptoms of
More informationExpanding Access to Movement Disorders Care and Research. Kevin M. Biglan, MD, MPH Rochester, New York September 24, 2016.
Expanding Access to Movement Disorders Care and Research Kevin M. Biglan, MD, MPH Rochester, New York September 24, 2016 Disclosures Presbyterian Home of Central New York Susquehanna Nursing and Rehabilitation
More informationPHYSICAL ACTIVITY SCALE FOR THE ELDERLY ( P A S E ) 1991 New England Research Institutes, Inc.
PHYSICAL ACTIVITY SCALE FOR THE ELDERLY ( P A S E ) 1991 New England Research Institutes, Inc. New England Research Institutes, Inc. 9 Galen Street Watertown, MA 02472 (617) 923-7747 INSTRUCTIONS: Please
More informationBRL /RSD-101RLL/1/CPMS-716. Report Synopsis
Report Synopsis Study Title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Long-term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive
More informationClinical Trial Synopsis
Clinical Trial Synopsis Title of Study: A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long-Term Administration of TAK-375 in Subjects With Chronic Insomnia Protocol Number: Name
More informationClinical Trial Results Database Page 1
Page 1 Sponsor Novartis UK Limited Generic Drug Name Letrozole/FEM345 Therapeutic Area of Trial Localized ER and/or PgR receptor positive breast cancer Study Number CFEM345EGB07 Protocol Title This study
More informationBig Data and Parkinson s Disease: Exploration, Analyses, and Data Challenges.
Proceedings of the 51 st Hawaii International Conference on System Sciences 2018 Big Data and Parkinson s Disease: Exploration, Analyses, and Data Challenges. Mahalakshmi SenthilarumugamVeilukandammal
More informationA comparison of exercise intervention to standard care in decreasing fall risk for patients with Parkinson s disease
Pacific University CommonKnowledge PT Critically Appraised Topics School of Physical Therapy 2014 A comparison of exercise intervention to standard care in decreasing fall risk for patients with Parkinson
More informationBristol-Myers Squibb
A Study of the Safety and Efficacy of plus Tenofovir in Adults with Chronic Hepatitis B Virus Infection with Previous Nucleoside/Nucleotide Treatment Failure () FINAL CLINICAL STUDY REPORT EUDRACT Number:
More informationLa neurosonologia. Ecografia cerebrale e nuove applicazioni nelle malattie neurodegenerative. Nelle patologie degenerative e vascolari cerebrali
La neurosonologia Nelle patologie degenerative e vascolari cerebrali Andrea Pilotto Ecografia cerebrale e nuove applicazioni nelle malattie neurodegenerative Prof. Daniela Berg Department of Neurodegeneration
More informationAnne M. Calkins, 1 Joseph Shurman, 2 Mark Jaros, 3 Richard Kim, 4 Gwendoline Shang 4. New York Spine and Wellness Center, North Syracuse, NY; 2
Peripheral Edema and Weight Gain in Adult Patients With Painful Diabetic Peripheral Neuropathy Receiving Gabapentin Enacarbil or Pregabalin Enrolled in a Randomized, Phase 2 Trial Anne M. Calkins, 1 Joseph
More informationClinical Trial Results Database Page 1
Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Corporation Generic Drug Name Therapeutic Area of Trial Major Depressive Disorder (MDD) Approved Indication Treatment of major depressive
More informationSponsor Novartis. Generic Drug Name Fluvastatin. Therapeutic Area of Trial Dyslipidemia
Page 1 Sponsor Novartis Generic Drug Name Fluvastatin Therapeutic Area of Trial Dyslipidemia Approved Indication Therapeutic area and approved indications in Germany: Hypercholesterolemia (HC), combined
More informationI. Kalfus MD, D. Riff MD, R. Fathi PhD, D. Graham MD
A Randomized Double Blind Placebo Controlled Phase III Study to Assess the Safety and Efficacy of Rifabutin Triple Therapy (RHB-105) for Helicobacter pylori (H. pylori) Infection in Dyspepsia Patients
More informationNon-motor and neuropsychiatric features of Parkinson s. disease. David Andrew Gallagher. Submitted to University College, London for the
Non-motor and neuropsychiatric features of Parkinson s disease David Andrew Gallagher Submitted to University College, London for the degree of Doctor of Philosophy 1 Author Declaration I, David Andrew
More informationBRL /RSD-101C0F/1/CPMS-716. Report Synopsis
Report Synopsis Study Title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Long-Term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationLate Stage PD: clinical problems & management issues
Late Stage PD: clinical problems & management issues Miguel Coelho, MD Neurological Department, Hospital Santa Maria Clinical Pharmacology Unit, IMM, Lisbon Portugal 26 September 2014 Nothing to declare.
More informationIntroduction to Experiments
Experimental Methods in the Social Sciences Introduction to Experiments August 5, 2013 Experiments Increasingly Important in the Social Sciences Field experiments in political science as early as 1920s
More informationRacial/Ethnic Disparities in Second Breast Lesions after DCIS. Graham A. Colditz, MD DrPH Kevin Garza Ying Liu, MD PhD Rosy Luo, PhD Yu Tao, PhD
Racial/Ethnic Disparities in Second Breast Lesions after DCIS Graham A. Colditz, MD DrPH Kevin Garza Ying Liu, MD PhD Rosy Luo, PhD Yu Tao, PhD Why DCIS? DCIS over 45,000 cases per year SEER 18 Cancer
More informationLRRK2 AS THERAPEUTIC TARGET. Jan Egebjerg
LRRK2 AS THERAPEUTIC TARGET Jan Egebjerg Scientific and Medical Rationale(s) Scientific Strong genetic evidence causally associates LRRK2 to familial PD. Combined genetic and biochemical evidence supports
More informationPFIZER INC. GENERIC DRUG NAME and/or COMPOUND NUMBER: 5% Spironolactone Cream/ PF
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationQuality ID #291: Parkinson s Disease: Cognitive Impairment or Dysfunction Assessment National Quality Strategy Domain: Effective Clinical Care
Quality ID #291: Parkinson s Disease: Cognitive Impairment or Dysfunction Assessment National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY MEASURE
More informationPFIZER INC. Study Initiation Date and Completion Dates: 09 March 2000 to 09 August 2001.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationChallenges in detecting disease modification in Parkinson s disease clinical trials
Challenges in detecting disease modification in Parkinson s disease clinical trials Dr Dilan Athauda, Sobell Department of Motor Neuroscience, UCL Institute of Neurology & The National Hospital for Neurology
More informationManagement of Individuals with Parkinson s Disease Using Principles of LSVT Big Therapy
Management of Individuals with Parkinson s Disease Using Principles of LSVT Big Therapy Iowa Physical Therapy Association Student Conclave Saturday April 20, 2013 Presented by Michael Puthoff, PT, PhD,
More informationStudy Number CAIN457C2302 (core study) and CAIN457C2302E1 (extension study)
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Uveitis Approved Indication Investigational Study Number CC2302 (core study) and CC2302E1
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationClinical Trial Report Synopsis
Clinical Trial Report Synopsis Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm 2 on the Chest Design of trial: Part
More informationViral Meningitis. 2. Use the information on the Possible Diseases sheet to complete the other four columns in the chart.
Disease Detectives Part 1: What is wrong with Mike? Yesterday, Mike Wright developed a severe headache, a high fever, and a stiff neck. Then, he became nauseated and began vomiting. He just wanted medicine
More informationAppendix N: Research recommendations
Appendix N: recommendations N.1 First-line treatment of motor symptoms recommendation 1 Interventions What is the effectiveness of initial levodopa monotherapy versus initial levodopa-dopamine agonist
More informationEfficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies
Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies Michael J. Koren, 1 Evan A. Stein, 2 Eli M. Roth, 3 James M. McKenney, 4 Dan Gipe,
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThe Latest Research in Parkinson s Disease. Lawrence Elmer, MD, PhD Professor, Dept. of Neurology University of Toledo
The Latest Research in Parkinson s Disease Lawrence Elmer, MD, PhD Professor, Dept. of Neurology University of Toledo OR.. Rethinking Parkinson s Disease Lawrence Elmer, MD, PhD Professor, Dept. of Neurology
More informationSleep Complaints and Disorders in Epileptic Patients 순천향의대천안병원순천향의대천안병원신경과양광익
Sleep Complaints and Disorders in Epileptic Patients 순천향의대천안병원순천향의대천안병원신경과양광익 Introduction The global physical, social and economic consequence of epilepsy are high. WHO 2000 study Improving QoL is increasingly
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationHow to Diagnose Early (Prodromal) Lewy Body Dementia. Ian McKeith MD, FRCPsych, F Med Sci.
How to Diagnose Early (Prodromal) Lewy Body Dementia Ian McKeith MD, FRCPsych, F Med Sci. Parkinson s Disease Lewy Body Disease Time PD Dementia Lewy Body Dementias Dementia with Lewy Bodies (DLB) Diagnostic
More informationMAPS Study MT1 CRF Page 1. Baseline Evaluations: Record clinically significant findings on the Medical History CRF
MAPS Study MT1 CRF Page 1 Demographics Date of Screening - - dd mmm yyyy (may start up to one month prior to enrollment) Date of Birth: - - dd mmm yyyy Visit #1 Date of Enrollment - - dd mmm yyyy Sex:!
More information