Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Sertraline (Zoloft)
  • Sertraline: range of 25 to 125 mg per day for 24 weeks
• Drug: Placebo
  • Placebo designed to mimic sertraline taken daily for 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will receive sertraline
• Placebo Comparator: 2
  • Participants will receive placebo

Primary Measures

• Depression remission (measured by the Cornell Scale for Depression in Dementia) and a global response measure (mADCS-CGI measuring mood, activity enjoyment, neurovegetative function and depressive cognitions.)
  • Time Frame: Measured at Week 12
    Safety Issue?: Yes

Secondary Measures

• Caregiver Burden and Quality of Life
  • Time Frame: Measured at Weeks 24, 36, and 48
    Safety Issue?: No
• Patient Cognitive Functioning, Quality of Life
  • Time Frame: Measured at Weeks 24, 36, and 48
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Constantine G. Lyketsos, MD, MHS Study Chair Johns Hopkins University  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00086138

Study ID Number: U01 MH066136

ClinicalTrials.gov Identifier: NCT00086138

Health Authority: United States: Federal Government