Depression in Alzheimer's Disease-2

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Depression in Alzheimer's Disease (DIADS-2)

Conditions
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Alzheimer's Disease, Depression

Intervention / Treatment
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* Drug: Sertraline (Zoloft)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion: Ability of the participant, caregiver or surrogate to provide written informed consent. Dementia due to Alzheimer's disease Stable treatment for Alzheimer's disease Ability for the participant's caregiver to accompany the participant to study visits and participate in the study. Exclusion Presence of a brain disease that might otherwise explain the presence of dementia Clinically significant hallucinations or delusions Current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications Need for hospitalization or residence in a nursing facility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive sertraline at a target dose of 100mg daily. | Drug: Sertraline (Zoloft)<br>* Sertraline: range of 25 to 125 mg per day for 24 weeks<br>|
| Placebo Comparator: 2<br>Participants will receive placebo matched to sertraline | Drug: Placebo<br>* Placebo designed to mimic sertraline taken daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Depression