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.

Condition	Treatment or Intervention	Phase
Alzheimer's Disease Depression	Drug: sertraline (Zoloft)  Drug: Placebo	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  130

Genders Eligible for Study:  Both

Criteria

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 for at least 3 months
• Ability for the participants 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
• Need for hospitalization or residence in a nursing facility

Kostas Lyketsos, MD      410.955.6185    kostas@jhmi.edu

California
      University of Southern California, Los Angeles,  California,  90033,  United States; Recruiting
Maryland
      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States; Recruiting
New York
      University of Rochester, Rochester,  New York,  14620,  United States; Recruiting
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
South Carolina
      Medical University of South Carolina, North Charleston,  South Carolina,  29406,  United States; Recruiting

Study chairs or principal investigators

Kostas Lyketsos, MD,  Study Chair,  Johns Hopkins University   

Study ID Numbers:  1U0166136
Record last reviewed:  March 2005
Last Updated:  March 24, 2005
Record first received:  June 25, 2004
ClinicalTrials.gov Identifier:  NCT00086138
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08