Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of Southern California
- Study ID
- NCT02434393
- Status
- Recruiting
Conditions
- Late Life Depression (LLD)
- Major Depression
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The purpose of this research study is to characterize the mechanisms contributing to cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD). This is a non-randomized, observational, non-treatment study that originally launched in 2015, enrolling 133 participants. From the originally enrolled participants, the continuation of the ADNI-D study will enroll 120 participants which will include following participants from the original (parent) protocol and enrollment of new participants for a period of 30 months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for comparison. Depression history, symptom severity and health information will be collected at the initial visit to determine eligibility. An magnetic resonance imaging (MRI) scan, as well as amyloid (florbetapir) and tau (flortaucipr) positron emission tomography (PET) imaging will be conducted at San Francisco VA. Collection of plasma and serum for biomarkers, clinical assessments and cognitive assessments will be conducted at two time points. Blood samples will also be collected for genetic analysis.
Key Dates
- Start date
- Mar 4, 2015
- Status verified
- Nov 2025
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 120 participants (estimated)
Arms
- Arm: Late Life Depression120 participants who meet the criteria for Major Depression or Late Life Depression (LLD)
Primary Outcome Measure
Rate of Change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct. [ Time Frame: 5 years (parent protocol), 5 years (continuation) ]
Central Contacts
- Nithya Ganesh(415) 300-0582
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | Scott Mackin, Ph.D. (PRINCIPAL_INVESTIGATOR) Duygu Tosun, Ph.D. (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | - |
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