Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
120 older adults meeting criteria for Major Depression or Late Life Depression (LLD).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: Late Life Depression
Trial outcomes
Primary outcomes
1
Rate of Change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct.
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.
Time frame
5 years (parent protocol), 5 years (continuation)2
Rate of Change in expressive language as measured by the Boston Naming Test using total correct.
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.
Time frame
5 years (parent protocol), 5 years (continuation)3
Rate of change in learning and memory as measured by the Rey Auditory Verbal Learning Test using total correct and delayed recall.
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.
Time frame
5 years (parent protocol), 5 years (continuation)4
Change in brain structure using magnetic resonance imaging (MRI)
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.
Time frame
5 years (parent protocol), 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).
Data from participants will be entered into the NIH Genome-Wide database and made available to the scientific community.
Time frame
5 years (parent protocol), 5 years (continuation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
University of California, San Francisco
Collaborator
Alzheimer's Therapeutic Research Institute
Collaborator
Source ClinicalTrials.gov