15Screening SummarySS217 Aug 06 Depression in Alzheimer s Disease Study - 2 DIADS-2 Screening Summary (SS2) Keyed: ( ) Purpose: Document findings about eligibility for DIADS-2 and about medical and social history. When: Screening visit. By whom: Study physician, nurse, or coordinator. Instructions: This should be the first form completed at the screening visit. Unless otherwise indicated in an item instruction, items do not need to be asked as written. Items should be answered based on the interviewer s assessment of information provided by the patient and/or caregiver. If a is checked, the person is currently ineligible for the trial; it is not necessary to continue with this form. The Ineligibility Summary (IS) form should be completed. A indicates cautionary instructions. See DIADS-2 Handbook for instructions on assigning codes for clinic, patient, caregiver, and visit identification. A. Clinic, patient, and visit identification 1. Clinic ID: 10. Has the caregiver signed the consent: 2. 3. Patient four-letter code: 4. Date of visit: month day year 5. Visit ID: s c r 6. Form & revision: s s 2 7. Sequence number of this SS form: First form completed on any date is numbered 1; if additional forms are needed, number the forms sequentially and complete the appropriate sections. 8. Caregiver four-letter code: B. Consent information 9. Has the patient (and/or legal representative) signed the consent: If, the patient (and/or legal representative) must sign the consent before proceeding. If, the caregiver must sign the consent before proceeding. C. Patient demographic information 11. Age: 12. Date of birth: 13. Gender: month day year years Male............................... Female.............................. 14. Read question as written: How do you primarily describe your race/ethnicity (check all that apply): a. African-American................. b. American Indian/Alaskan Native..... c. Asian........................... d. Caucasian....................... e. Hispanic/Latino................... f. Pacific Islander/Native Hawaiian..... g. Other........................... h. Refused......................... Revision 2 (17 Aug 06) Screening Summary 1 of 15
15. What is the highest level of school or educational degree obtained: formal education................... 1 year.............................. 2 years............................. ( 3) 3 years............................. ( 4) 4 years............................. ( 5) 5 years............................. ( 6) 6 years............................. ( 7) 7 years............................. ( 8) 8 years............................. ( 9) 9 years............................. ( 10) 10 years............................ ( 11) 11 years (no high school diploma)........ ( 12) 12 years (high school diploma or General Educational Development (GED) certificate).................... ( 13) 13 years (some college)................ ( 14) 14 years (some college or associate s degree)............................. ( 15) 15 years............................ ( 16) 16 years (college degree; BA, BSc, etc).... ( 17) 17 years (some graduate work).......... ( 18) 18 years (post baccalaureate degree; MA; MSc, etc)............................ ( 19) 19 years (some doctoral work)........... ( 20) 20 years (doctoral degree).............. ( 21) 16. Total number of years completed of formal education: 17. Marital status: years Married............................. Widowed........................... Separated........................... ( 3) Divorced............................ ( 4) Never married........................ ( 5) D. Caregiver demographic information 18. Does the patient have a primary caregiver available to accompany the patient to study visits and to participate in the study: 19. What is the relationship of the caregiver to the patient (check one): Spouse.............................. Significant other...................... Sibling.............................. ( 3) Son/son-in-law/daughter/daughter-in-law.. ( 4) Grandchild.......................... ( 5) Paid caregiver........................ ( 6) Friend.............................. ( 7) Parent/parent-in-law................... ( 8) Other............................... ( 9) 20. Age: 21. Gender: years Male............................... Female.............................. 22. Read question as written: How do you primarily describe your race/ethnicity (check all that apply): a. African-American................. b. American Indian/Alaskan Native..... c. Asian........................... d. Caucasian....................... e. Hispanic/Latino.................. f. Pacific Islander/Native Hawaiian..... g. Other........................... h. Refused......................... Revision 2 (17 Aug 06) Screening Summary 2 of 15
23. What is the highest level of school or educational degree obtained: formal education................... 1 year.............................. 2 years............................. ( 3) 3 years............................. ( 4) 4 years............................. ( 5) 5 years............................. ( 6) 6 years............................. ( 7) 7 years............................. ( 8) 8 years............................. ( 9) 9 years............................. ( 10) 10 years............................ ( 11) 11 years (no high school diploma)........ ( 12) 12 years (high school diploma or General Educational Development (GED) certificate).................... ( 13) 13 years (some college)................ ( 14) 14 years (some college or associate s degree)............................. ( 15) 15 years............................ ( 16) 16 years (college degree; BA, BSc, etc).... ( 17) 17 years (some graduate work).......... ( 18) 18 years (post baccalaureate degree; MA; MSc, etc)............................ ( 19) 19 years (some doctoral work)........... ( 20) 20 years (doctoral degree).............. ( 21) 24. Total number of years completed of formal education: years E. Personal data related to eligibility 26. Where does the patient reside: Own home........................... Caregiver s home..................... Assisted living....................... ( 3) Nursing facility....................... ( 4) Other............................... ( 5) 27. Is the patient currently participating in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes: 28. Is English the patient s first language: 29. Do the patient and caregiver have sufficient fluency in written and spoken English to participate in study visits, neuropsychological testing, and other outcome assessments: 25. Marital status: Married............................. Widowed........................... Separated........................... ( 3) Divorced............................ ( 4) Never married........................ ( 5) Revision 2 (17 Aug 06) Screening Summary 3 of 15
F. Medical and psychological data related to eligibility 30. Does the patient have a diagnosis of dementia due to Alzheimer s disease by DSM-IV (TR) criteria: 36. Does the patient need hospitalization for depression: 37. Is the patient suicidal: 31. Does the patient have a Mini-Mental State Exam (MMSE) score in the range of 10 to 26 inclusive: If, score: 38. Is the patient in sufficiently good health to be treated using the study protocol in usual care circumstances: 32. Does the patient have a diagnosis of Depression of Alzheimer s Disease as operationalized in the DIADS-2 handbook: G. Treatment history related to eligibility 39. Is the patient currently on treatment for Alzheimer s disease: 41. 33. Does the patient have the presence of a brain disease that might otherwise fully explain the presence of dementia, such as stroke, Parkinson s disease, traumatic brain injury, multiple sclerosis, or similar: 40. Has the patient been on stable treatment for Alzheimer s disease (eg, vitamin E, memantine, or cholinesterase inhibitors) for at least 3 months prior to the screening visit: 34. Does the patient have clinically significant hallucinations (score of 4 on NPI hallucinations domain) or the need, in the opinion of the study psychiatrist, for antipsychotic medication: Treatment for Alzheimer s disease must be stable for at least 3 months prior to randomization. 41. Has the patient been treated with antipsychotics in the 2 weeks prior to the screening visit: 35. Does the patient have clinically significant delusions that, in the opinion of the psychiatrist, require antipsychotic medication: The patient cannot be treated with antipsychotics in the 2 weeks prior to randomization. Revision 2 (17 Aug 06) Screening Summary 4 of 15
42. Does the patient have contraindications for treatment with sertraline, in the opinion of the attending psychiatrist (ie, history of dangerous or unacceptable side effects with sertraline treatment): 43. Has the patient failed treatment with sertraline in the current episode of depression after convincing evidence of a good trial (ie, 8 weeks at the highest tolerated dose): 44. Is the patient being treated with a medication that would prohibit the safe concurrent use of sertraline, such as selegeline: 45. Is the patient currently being treated with antipsychotics, anticonvulsants, other antidepressants, benzodiazepines, or other psychotropic medications: 46. Is the patient willing to discontinue psychotropic medications to enter the trial: 47. Revision 2 (17 Aug 06) Screening Summary 5 of 15
H. Psychiatric history 47. Patient s family history for first degree blood relative(s) (check only one for each row): Unknown a. Alzheimer's disease... ( 1 ) ( 2 ) ( 3 ) b. Other dementia... ( 1 ) ( 2 ) ( 3 ) c. Major depression... ( 1 ) ( 2 ) ( 3 ) d. Bipolar disorder... ( 1 ) ( 2 ) ( 3 ) e. Other mood disorder... ( 1 ) ( 2 ) ( 3 ) f. Other psychiatric disorder... ( 1 ) ( 2 ) ( 3 ) g. Alcohol use disorder... ( 1 ) ( 2 ) ( 3 ) 48. Patient s family history for other blood relative(s) (check only one for each row): Unknown a. Alzheimer's disease... ( 1 ) ( 2 ) ( 3 ) b. Other dementia... ( 1 ) ( 2 ) ( 3 ) c. Major depression... ( 1 ) ( 2 ) ( 3 ) d. Bipolar disorder... ( 1 ) ( 2 ) ( 3 ) e. Other mood disorder... ( 1 ) ( 2 ) ( 3 ) f. Other psychiatric disorder... ( 1 ) ( 2 ) ( 3 ) g. Alcohol use disorder... ( 1 ) ( 2 ) ( 3 ) 49. Patient s personal history before onset of AD: Unknown a. Major depression... ( 1 ) ( 2 ) ( 3 ) b. Bipolar disorder... ( 1 ) ( 2 ) ( 3 ) c. Other mood disorder... ( 1 ) ( 2 ) ( 3 ) d. Other psychiatric disorder... ( 1 ) ( 2 ) ( 3 ) e. Alcohol use disorder... ( 1 ) ( 2 ) ( 3 ) 6 of 15 Revision 2 (17 Aug 0 6) Screening Summary
I. Dementia history 50. Age at first onset of any cognitive symptoms: 51. Age at onset of dementia: years years List medications and doses used for depression in this episode of Depression of Alzheimer s Disease (include prescription medications, vitamins, herbals, and over-the-counter medications). 60. Medication #1: 52. Date of diagnosis of dementia (mm/yyyy): month year name J. Depression history 53. Age at first onset of any syndromic depression: 54. Number of episodes of any syndromic depression starting before onset of cognitive symptoms: years dose (mg) frequency duration 55. Number of episodes of any syndromic depression starting after onset of cognitive symptoms: 56. Duration of current episode of Depression of Alzheimer s Disease : # of episodes # of episodes 61. Medication #2: name dose (mg) 57. Has the patient taken medication for this episode of Depression of Alzheimer s Disease : weeks 64. frequency duration 58. Number of any medication trials for this episode of Depression of Alzheimer s Disease : # of trials 59. Number of good medication trials for this episode of Depression of Alzheimer s Disease (ie, 8 weeks of the highest tolerated dose): # of trials Revision 2 (17 Aug 06) Screening Summary 7 of 15
62. Medication #3: name dose (mg) frequency duration 63. Medication #4: name 65. What services have been used for this episode of Depression of Alzheimer s Disease (check all that apply): a. services..................... b. Daycare......................... c. Respite care...................... d. Other........................... K. Current co-morbid medical illness 66. Does the patient have any current co-morbid medical illnesses: 67. Co-morbid medical illness(es): a. Illness #1 68. dose (mg) b. Illness #2 frequency duration 64. Has the patient had any treatment other than medication for this episode of Depression of Alzheimer s Disease (check all that apply): a. treatment..................... b. Psychotherapy.................... c. Psychiatric admission.............. d. Other.......................... c. Illness #3 d. Illness #4 e. Illness #5 Revision 2 (17 Aug 06) Screening Summary 8 of 15
f. Illness #6 L. Current medications for Alzheimer s disease g. Illness #7 68. Is the patient currently taking medication for Alzheimer s disease: 74. h. Illness #8 If, record current medication, dose, frequency, and duration of treatment for Alzheimer s disease in items 69-73. 69. Memantine (Namenda ): i. Illness #9 a. Is the patient currently taking memantine dose (mg) 70. j. Illness #10 frequency duration 70. Donepezil (Aricept ): a. Is the patient currently taking donepezil 71. dose (mg) frequency duration Revision 2 (17 Aug 06) Screening Summary 9 of 15
71. Rivastigmine (Exelon ): M. Other current medications a. Is the patient currently taking rivastigmine 72. 74. Is the patient currently taking any medications other than those recorded in section L: 85. dose (mg) If, list current medication, indication, dose, frequency and route of intake in items 75-84, (include prescription medication, vitamins, herbals, and over-the-counter medicines). frequency 75. Medication #1: duration name 72. Galantamine (Reminyl ): a. Is the patient currently taking galantamine 73. indication dose (mg) dose (mg) frequency duration 73. Vitamin E: a. Is the patient currently taking a dose of vitamin E 1,000 IU per day 74. frequency Oral............................. IM.............................. dose (mg) frequency duration Revision 2 (17 Aug 06) Screening Summary 10 of 15
76. Medication #2: name indication Oral............................. IM.............................. dose (mg) 78. Medication #4: frequency Oral............................. IM.............................. name indication dose (mg) frequency 77. Medication #3: name indication Oral............................. IM.............................. dose (mg) frequency Revision 2 (17 Aug 06) Screening Summary 11 of 15
79. Medication #5: name indication Oral............................. IM.............................. dose (mg) 81. Medication #7: frequency Oral............................. IM.............................. name indication dose (mg) frequency 80. Medication #6: name indication Oral............................. IM.............................. dose (mg) frequency Revision 2 (17 Aug 06) Screening Summary 12 of 15
82. Medication #8: name indication Oral............................. IM.............................. dose (mg) 84. Medication #10: frequency Oral............................. IM.............................. name indication dose (mg) frequency 83. Medication #9: name indication Oral............................. IM.............................. dose (mg) frequency Revision 2 (17 Aug 06) Screening Summary 13 of 15
N. Physical assessment 85. Weight: 86. Height: 87. Blood pressure (after sitting for five minutes): a. Systolic b. Diastolic pounds inches mmhg mmhg d. Cardiovascular rmal.......................... Abnormal........................ If abnormal, : e. Chest rmal.......................... Abnormal........................ If abnormal, : 88. Pulse (after sitting for five minutes): 89. Respirations (after sitting for five minutes): beats/minute breaths/minute f. Abdominal rmal.......................... Abnormal........................ If abnormal, : 90. Physical examination: Evaluate each body system and abnormal findings. a. General appearance rmal.......................... Abnormal........................ If abnormal, : b. Skin rmal.......................... Abnormal........................ If abnormal, : g. Extremities/joints rmal.......................... Abnormal........................ If abnormal, : h. Neurological rmal.......................... Abnormal........................ If abnormal, : c. HEENT (head, eye, ear, nose, throat) rmal.......................... Abnormal........................ If abnormal, : Revision 2 (17 Aug 06) Screening Summary 14 of 15
i. Hearing rmal.......................... Abnormal........................ If abnormal, : j. Vision rmal.......................... Abnormal........................ If abnormal, : O. Overall clinical impression 91. In the opinion of the study clinician, is it appropriate to enroll the patient in DIADS-2: P. Assurance of review 92. Date form reviewed by study coordinator: month day year 93. Study coordinator ID: 94. Study coordinator signature: Study physician should review this form before signing below. 95. Date form reviewed by study physician: month day year 96. Study physician ID: 97. Study physician signature: Revision 2 (17 Aug 06) Screening Summary 15 of 15