Depression in Alzheimer's Disease-2

Depression in Alzheimer's Disease (DIADS-2)

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.

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