Recruiting

Cognitive Impairment

Sponsor:

University of Southern California

Code:

NCT02434393

Conditions

Major Depression

Late Life Depression (LLD)

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Major Depression

Late Life Depression (LLD)

Study ID

NCT02434393

Start date

Mar 4, 2015

Status verified date

Nov, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Late Life Depression

120 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) ]
  • Rate of Change in expressive language as measured by the Boston Naming Test using total correct. [ Time Frame: 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. [ Time Frame: 5 years (parent protocol), 5 years (continuation) ]
  • Change in brain structure using magnetic resonance imaging (MRI) [ Time Frame: 5 years (parent protocol), 5 years (continuation) ]
  • Extent of amyloid deposition as measured by florbetapir [ Time Frame: 5 years (parent protocol), 5 years (continuation) ]
  • Extent of tau deposition as measured by flortaucipr [ Time Frame: 5 years (continuation) ]

Central Contacts and Locations

Central contacts

Nithya Ganesh

(415) 300-0582nithya.ganesh@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Scott Mackin, Ph.D.

More Information

Sponsor

University of Southern California

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Keywords

  • Depression
  • Late Life Depression
  • LLD
  • amyloid imaging
  • biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-11-25.