Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project (ADNI-D)

University of Southern California

Status: Enrolling

Conditions: Major Depression; Late Life Depression (LLD)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02434393

ADC-048

R01MH098062 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

120 participants in 1 patient group

Late Life Depression

Description:

120 participants who meet the criteria for Major Depression or Late Life Depression (LLD)