The main objective of this study is to evaluate the efficacy and safety of sertraline for the treatment of depression in patients with Alzheimer's disease.
What are the secondary objectives of this study?
The other objectives of this study are:
To determine whether treatment of depression affects critical non-mood outcomes in patients with Alzheimer's disease and in their caregivers
To characterize the syndrome of depression of Alzheimer's disease over time and its effect on patients and caregivers
How will the study be conducted?
The study is a randomized, multicenter clinical trial with two parallel treatment groups. Treatment assignment is stratified by field site and employs a 1:1 assignment ratio among the two treatment groups. Treatment assignment is masked to participants and all site personnel, including physicians, nurses, and neuropsychologists.
How many patients will be participating in the study?
A total of 130 patients will be recruited for the study with 30 patients from USC.
Who is eligible to participate in this study?
The following are the eligibility criteria for this study:
Dementia due to Alzheimer's disease by DSM-IV (TR), with MMSE score of 10-26 inclusive
Depression of Alzheimer's disease as operationalized in the DIADS handbook
Sufficiently good health to be treated using the study protocol in usual care circumstances
Provision of informed consent for participation in the study by patient, caregiver, or surrogate (if necessary)
Stable treatement for Alzheimer's disease (e.g., Vitamin E, memantine, or cholinesterase inhibitors) for at least 3 months prior to randomization
Availability of patient's primary caregiver to acconpany the patient to study visits and to paticipate in the study
How can I enroll in this study?
This study is currently enrolling volunteers. If interested, please contact:
Maya Slowinska
University of Southern California Keck School of Medicine
(323) 442-7600
e-mail: mslowins@usc.edu
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