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| ID | Type | Description | Link |
|---|---|---|---|
| U01MH066136 | U.S. NIH Grant/Contract | View source | |
| DATR A4-GPX |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers.
Participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. There are 8 scheduled in-person visits in the 24 weeks. Visits include neuropsychological testing. Caregivers are asked to are the patient on a Daily Affect Diary for 6 weeks during the study period. Telephone followup is done at weeks 36 and 48. Both groups receive caregiver support/education.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive sertraline at a target dose of 100mg daily. |
|
| 2 | Placebo Comparator | Participants will receive placebo matched to sertraline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline (Zoloft) | Drug | Sertraline: range of 25 to 125 mg per day for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) | At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change". | Measured at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Remission According to Cornell Scale for Depression in Dementia Scale | The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12. | Measured at Weeks 12 |
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Inclusion:
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Constantine G. Lyketsos, MD, MHS | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20087081 | Result | Rosenberg PB, Drye LT, Martin BK, Frangakis C, Mintzer JE, Weintraub D, Porsteinsson AP, Schneider LS, Rabins PV, Munro CA, Meinert CL, Lyketsos CG; DIADS-2 Research Group. Sertraline for the treatment of depression in Alzheimer disease. Am J Geriatr Psychiatry. 2010 Feb;18(2):136-45. doi: 10.1097/JGP.0b013e3181c796eb. | |
| 20672243 | Derived | Drye LT, Martin BK, Frangakis CE, Meinert CL, Mintzer JE, Munro CA, Porsteinsson AP, Rabins PV, Rosenberg PB, Schneider LS, Weintraub D, Lyketsos CG; DIADS-2 Research Group. Do treatment effects vary among differing baseline depression criteria in depression in Alzheimer's disease study +/- 2 (DIADS-2)? Int J Geriatr Psychiatry. 2011 Jun;26(6):573-83. doi: 10.1002/gps.2565. |
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Participants were recruited from memory clinics at five academic centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks |
| FG001 | Sertraline | Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline | Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) | At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change". | Posted | Number | participants | Measured at Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertraline | Participants will receive sertraline at a target dose of 100mg daily. Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia/respiratory infection | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Rosenberg | JHU | 410-550-9883 | prosenb9@jhmi.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Placebo |
| Drug |
Placebo designed to mimic sertraline taken daily for 24 weeks |
|
| Baltimore |
| Maryland |
| 21287 |
| United States |
| University of Rochester | Rochester | New York | 14620 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | North Charleston | South Carolina | 29406 | United States |
| 17068314 | Derived | Martin BK, Frangakis CE, Rosenberg PB, Mintzer JE, Katz IR, Porsteinsson AP, Schneider LS, Rabins PV, Munro CA, Meinert CL, Niederehe G, Lyketsos CG. Design of Depression in Alzheimer's Disease Study-2. Am J Geriatr Psychiatry. 2006 Nov;14(11):920-30. doi: 10.1097/01.JGP.0000240977.71305.ee. |
Participants will receive placebo matched to sertraline
Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Placebo |
Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks |
|
|
|
| Secondary | Remission According to Cornell Scale for Depression in Dementia Scale | The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12. | Posted | Number | percentage of participants | Measured at Weeks 12 |
|
|
|
|
| 13 |
| 67 |
| 44 |
| 67 |
| EG001 | Placebo | Participants will receive placebo matched to sertraline Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks | 7 | 64 | 26 | 64 |
| Neurologic | Nervous system disorders |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Cardiac | Cardiac disorders |
|
| Dizziness | Nervous system disorders |
|
| Dry mouth | Respiratory, thoracic and mediastinal disorders |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |