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NCT Number: NCT02434393

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

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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Late Life Depression (LLD) Mental Disorders Mood Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • Antidepressant medication treatment is allowed only if the medication dose is stable for 4 weeks prior to the MRI scan.
  • Psychotherapy interventions is allowed only if they have completed at least 4 weeks of individual or group psychotherapy intervention prior to the MRI scan.
  • Participants taking cognitive enhancing medications will be able to enter the study.

Treatment and study plan

Primary outcomes

  1. 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)

    The Digit Symbol subtest is a measure of attention, working memory, and information processing speed. Participants are presented with a stimulus sheet, and asked to write in the correct symbol that corresponds with a number keyed at the top of the page. A scaled score is calculated based on the number of total correct responses.

  2. 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)

    Boston Naming Test is a measure of visual confrontation naming requires the subject to name objects depicted in outline drawings. The drawings are graded in difficulty, with the easiest drawings presented first. If a subject encounters difficulty in naming an object, a stimulus cue and/or a phonemic cue is provided. The number of spontaneous correct responses (maximum score = 30) and spontaneous plus semantically-cued correct responses (maximum score = 30) are recorded. The number of perceptual errors, circumlocutions, paraphasic errors, and perseverations can also be used to evaluate the subjects' language performance.

  3. 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)

    Rey Auditory Verbal Learning Test (AVLT) is a list learning task which assesses multiple cognitive parameters associated with learning and memory. On each of 5 learning trials, 15 unrelated words (all nouns) are presented orally at the rate of one word per second and immediate free recall of the words is elicited. The number of correctly recalled words on each trial is recorded. Following a 20-minute delay filled with unrelated testing, free recall of the original 15 word list is elicited. Finally, a yes/no recognition test is administered which consists of the original 15 words and 15 randomly interspersed distracter words. The number of target "hits" and false positive responses are recorded.

  4. Change in brain structure using magnetic resonance imaging (MRI)

    Time frame: 5 years (parent protocol), 5 years (continuation)

    MRI will be used to conduct cortical thickness analysis of whole brain and hippocampus utilizing the following sequences: 3D T1-weighted volume, FLAIR, T2*GRE, and Arterial Spin-Labeling (ASL) Perfusion.

  5. Extent of amyloid deposition as measured by florbetapir

    Time frame: 5 years (parent protocol), 5 years (continuation)

    Data from these scans will be collected via standardized uptake value ratios (SUVR) normalized to the cerebellum

  6. Extent of tau deposition as measured by flortaucipr

    Time frame: 5 years (continuation)

Secondary outcomes

  1. Use biomarkers data employed in ADNI-2 and the NIA AD (Alzheimer's Disease) Genetics Consortium to determine the genotypes needed for the genome wide association study (GWAS).

    Time frame: 5 years (parent protocol), 5 years (continuation)

    Data from participants will be entered into the NIH Genome-Wide database and made available to the scientific community.

Study contacts

Contact information is provided by the study sponsor or research team.

Nithya Ganesh

CONTACT

[email protected]

(415) 300-0582

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Alzheimer's Therapeutic Research Institute
  • National Institute of Mental Health (NIMH)
  • University of California, San Francisco

Registry information

Official study title

Characterizing Cognitive Decline in Late Life Depression: The Alzheimer's Disease Neuroimaging Initiative - Depression Project

Acronym: ADNI-D

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
May 5, 2015
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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