Depression in Alzheimer's Disease-2

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Alzheimer's Disease Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Participants will receive sertraline at a target dose of 100mg daily.

Group Type EXPERIMENTAL

Sertraline (Zoloft)

Intervention Type DRUG

Sertraline: range of 25 to 125 mg per day for 24 weeks

2

Participants will receive placebo matched to sertraline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo designed to mimic sertraline taken daily for 24 weeks

Interventions

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Sertraline (Zoloft)

Sertraline: range of 25 to 125 mg per day for 24 weeks

Intervention Type DRUG

Placebo

Placebo designed to mimic sertraline taken daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No