Recruiting

Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project

ClinicalTrials.gov IDNCT02434393

PhaseNot Applicable

Enrollment120

SponsorUniversity of Southern California

Age65 Years

SexALL

I'm interested View official listing

Conditions studied

Major Depression, Late Life Depression (LLD)

About this study

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.

Primary outcomes

Rate of Change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct. (5 years (parent protocol), 5 years (continuation))
Rate of Change in expressive language as measured by the Boston Naming Test using total correct. (5 years (parent protocol), 5 years (continuation))
Rate of change in learning and memory as measured by the Rey Auditory Verbal Learning Test using total correct and delayed recall. (5 years (parent protocol), 5 years (continuation))
Change in brain structure using magnetic resonance imaging (MRI) (5 years (parent protocol), 5 years (continuation))
Extent of amyloid deposition as measured by florbetapir (5 years (parent protocol), 5 years (continuation))
Extent of tau deposition as measured by flortaucipr (5 years (continuation))

Eligibility information

Inclusion Criteria: 1\. Individual participated in original Characterizing Cognitive Decline in Late Life Depression study or Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression Study. Exclusion Exceptions: 1. Antidepressant medication treatment is allowed only if the medication dose is stable for 4 weeks prior to the MRI scan. 2. Psychotherapy interventions is allowed only if they have completed at least 4 weeks of individual or group psychotherapy intervention prior to the MRI scan. 3. Participants taking cognitive enhancing medications will be able to enter the study.

Study locations

University of California, San Francisco, San Francisco, California 94143 United States
University of Pittsburgh, Pittsburgh, Pennsylvania 15213 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.