Depression in Alzheimer's Disease-2 (DIADS-2)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
131 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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