Oscar L. Lopez, M.D. Departments of Neurology and Psychiatry Alzheimer s Disease Research Center University of Pittsburgh School of Medicine

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1 14th Annual Mild Cognitive Impairment Symposium The Wien Center for Alzheimer's Disease and Memory Disorders, Mount Sinai Medical Center Miami, Florida Markers of inflammation and immune activation, small vessel disease, amyloid deposition, and progression to dementia in non-demented individuals Oscar L. Lopez, M.D. Departments of Neurology and Psychiatry Alzheimer s Disease Research Center University of Pittsburgh School of Medicine

2 Introduction The association between inflammatory markers and brain amyloid deposition measured in vivo. The association between inflammatory markers and MRI-identified white matter lesions. The association between inflammatory markers and incidence dementia.

3 Program Project Grant (PPG) End of the study Incident Dementia 2000 Ginkgo Evaluation of Memory (GEM) study PPG: Annual Clinical exams -Biannual PiB, MRI, FDG. -Neuropathology Blood samples N= 198 (age: 83-96) PiB and MRI

4 Study Measures Plasma IL-6, sil-2r, and scd-14 were quantified by ELISA. Plasma soluble stnfr were quantified by Multiplex Millipore panel. High-sensitivity CRP (hs-crp) measured with laser nephelometry. Brain amyloid by Positron Emission Tomography using Pittsburgh Compound B (PiB-PET), PIB+= SUVR 1.57 White matter lesions (WMLs) measured with MRI, WMLs >75 percentile.

5 Systemic inflammation-related biomarkers associated PPG Inflammation with cognitive markers outcomes C Reactive Protein (CRP) unspecific marker of inflammation Biomarker Definition Interleukin 6 (IL-6) Interleukin 6 (IL-6) T-cell derived cytokine Pro-inflammatory cytokine secreted by T cells & Solublemacrophages IL2 receptor (sil2r) Marker of T-cell activation. Soluble IL-2 receptor (sil-2r) Soluble TNFα receptor (stnfαr) 1 and 2 Stimulates pro-inflammatory cytokines. non-specific marker of T-cell activation Soluble TNFα receptors stnfr1 & stnfr2 Soluble CD14 (scd14) Marker of monocyte activation stimulates proinflammatory cytokines including IL-6. C-reactive Soluble protein CD-14 (CRP)(sCD-14) Non-specific marker of inflammation marker of immune (monocyte) activation, stimulates IL- 6, TNFα Mackey, et al, 2013

6 Correlations among markers of inflammation (all positive correlations) sil2r IL6 stnfαr1 stnfαr2 scd-14 hscrp sil2r p= 0.30 p<0.001 p<0.001 p<0.001 p= 0.01 IL6 p=0.30 p=0.34 p= 0.26 p=0.003 p<0.001 stnfαr1 p<0.001 p=0.34 p<0.001 p<0.001 p=0.47 stnfαr2 p<0.001 p=0.26 p<0.001 p<0.001 p=0.53 scd-14 p<0.001 p=0.003 p<0.001 p<0.001 p<0.001 hscrp p=0.01 p<0.001 p=0.47 p=0.53 p<0.001

7 Characteristics of the participants Men (n=105) Women (n=78) Age, years 85.3 ± ± 2.80 Education level, years 14.9 ± ± 2.5 BMI, kg/m 2 26±3 26±5 Systolic BP, mmhg 125±17 130±19* Hypertension 33 (31%) 30 (40.5%) Diabetes mellitus 5 (5%) 5 (7%) Heart disease** 20 (19%) 12 (16%) *p=0.03 **History of congestive heart failure, angina, myocardial infarction, valve replacement, Stent, or CABG

8 *p<0.05 Characteristics of the participants Inflammation markers Men (n=105) Women (n=78) p-value hscrp, mg/l 2.5± ± IL-6, µg/ml 2.6± ± stnf-r1, pg/ml ± ± stnf-r2, pg/ml ± ± sil-2r, pg/ml ± ± scd-14, pg/ml ± ±

9 *p<0.05 Characteristics Inflammation of the markers participants and amyloid deposition PiB(-) PiB(+) p-value hscrp, mg/l 2.58± ± IL-6, µg/ml 2.8± ± stnf-r1, pg/ml ± ± stnf-r2, pg/ml ± ± sil-2r, pg/ml ± ± scd-14, pg/ml ± ±

10 Percent PiB positivity by scd-14 quartiles PiB(-) PiB(+) * 1st 2nd 3rd 4th scd-14 Quartiles *p= 0.005

11 PiB SUVR Amyloid deposition by scd-14 quartiles p=0.03 p=0.02 p=0.07 ANOVA: F=2.13, p=0.09 First Second Third Fourth scd-14 quartiles

12 Percent PiB positivity by stnf-r2 quartiles PiB(-) PiB(+) * 0 1st 2nd 3rd 4th stnf-r2 Quartiles *p= 0.09

13 PiB SUVR Amyloid deposition by stnfα r1quartiles First Second Third Fourth Amyloid deposition by stnfα r1quartiles

14 *p<0.05 Characteristics Inflammation of markers the participants and white matter lesions (WMLs) volume WMLs <75 percentile WMLs >75 percentile p-value hscrp, mg/l 2.79± ± IL-6, µg/ml 2.8± ± stnf-r1, pg/ml ± ± stnf-r2, pg/ml ± ± sil-2r, pg/ml ± ± scd-14, pg/ml ± ±

15 Percent WMLs volume by stnf-r1 quartiles WMLs <75% 1st 2nd 3rd 4th stnf-r1 Quartiles WMLs>75% * *p= 0.06

16 Percent WMLs volume by scd-14 quartiles WMLs <75% 1st 2nd 3rd 4th scd-14 Quartiles * WMLs>75% *p= 0.03

17 Diagnoses at the last clinic visit in Normal cognition MCI Dementia N of participants Age at baseline Men/Women 32/24 40/27 35/25 Education level BMI Hypertension 12 (22%) 28 (43%)* 23 (39%)* Diabetes mellitus 2 (4%) 4 (6%) 4 (7%) Heart disease** 10 (18%) 9 (28%) 13 (22%) *p= 0.03 **History of congestive heart failure, angina, myocardial infarction, valve replacement, Stent, or CABG

18 Inflammation markers by diagnoses at hscrp, mg/l IL-6, µg/ml stnf-r1, pg/ml stnf-r2, pg/ml sil-2r, pg/ml scd-14, pg/ml Normal cognition MCI Dementia

19 Inflammation markers by diagnoses at N of participants Normal cognition MCI incident or prevalent Dementia < 2.5 years Dementia >2.5 years hscrp, mg/l IL-6, µg/ml * stnf-r1, pg/ml stnf-r2, pg/ml sil-2r, pg/ml scd-14, pg/ml ANOVA: F= 281, p=0.04

20 Comments They are higher among women than men. They are weakly associated with amyloid deposition in the brain (PiB+) They are weakly associated with white matter lesions volume. There is a trend for the prediction of imminent incident dementia (within 2.5 years). They are not long term predictors of dementia Mackey, et al, 2013

21 Characteristics of 1,319 participants of the GEM Study included in the study Fitzpatrick et al Female (n= 597) Male (n=722) Mean / N (SD / %) Mean / N (SD / %) p-value Age Race White % % 0.15 Non-White % % Education (years) <0.001 Hypertension % % 0.06 Diabetes % % 0.16 History of CHD % % <0.001 BMI Ɨ Alcohol (drinks/wk) <0.001 Smoking status Never smoked % % <0.001 Former smoker % % Current smoker % % APOE4 carrier % % 0.012

22 Risk of incident dementia and subtype of dementia for a standard deviation increase in PTX3 and SAP Adjusted Physical Function and Adjusted for Demographics 1 Adjusted for CVD Risk Factors 2 APOE-4 3 HR (95% CI) p HR (95% CI) p HR (95% CI) p All Dementia (523/1319)* (504/1271)* (379/997)* PTX3 (ng/ml) SAP (ng/ml) 1.20 ( ) 0.91 (0.83 to 1.00) < (1.10 to 1.28) 0.93 (0.84 to 1.03) < (1.06 to 1.26) 0.95 (0.84 to 1.07) AD (353/1319)* (341/1271)* (252/997)* PTX3 (ng/ml) SAP (ng/ml) 1.16 (1.05 to 1.28) 0.84 (0.75 to 0.95) (1.02 to 1.26) 0.88 (0.78 to 0.99) (1.00 to 1.26) 0.92 (0.79 to 1.07) Mixed/ VaD (148/1319)* (142/1271)* (106/997)* PTX3 (ng/ml) < (1.08 to 1.27) (1.06 to 1.26) (1.02 to 1.24) 0.02 SAP (ng/ml) (0.82 to 1.00) (0.83 to 1.03) (0.83 to 1.07) 0.35 (1) Adjusted for age, gender, race, education, clinic, and GEMS treatment assignment.. (2) Adjusted for demographics + hypertension, diabetes, history of MI, angina, heart failure, stroke, TIA, cardiac procedures, BMI, use of tobacco and alcohol. (3) Adjusted for demographics, CVD RFs + gait speed, activities of daily life and ApoE genotype. (4) * N = dementia cases / total sample. Fitzpatrick et al. et 2015 al. 2014

23 Mean serum levels of PTX3 and SAP at baseline by dementia status of participants at end of follow-up *p > 0.50; **p=0.01; ***p < Fitzpatrick et al. 2015

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