Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project (ADNI-D)
|ClinicalTrials.gov Identifier: NCT02434393|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : February 20, 2019
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. One hundred and twenty (120) subjects who meet criteria for Major Depression or LLD will be enrolled 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 psychiatric visit to determine eligibility. A 3 Tesla (3T) Magnetic resonance imaging (MRI) scan and florbetapir (18F-AV-45) amyloid imaging will be conducted at the ADNI clinic site visits. 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.
|Condition or disease|
|Major Depression Late Life Depression (LLD)|
|Study Type :||Observational|
|Actual Enrollment :||133 participants|
|Official Title:||Characterizing Cognitive Decline in Late Life Depression: The Alzheimer's Disease Neuroimaging Initiative - Depression Project|
|Actual Study Start Date :||March 4, 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Late Life Depression
120 participants who meet the criteria for Major Depression or Late Life Depression (LLD)
- Rate of Change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct. [ Time Frame: 5 years ]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.
- Rate of Change in expressive language as measured by the Boston Naming Test using total correct. [ Time Frame: 5 years ]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.
- 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 ]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.
- Change in brain structure using magnetic resonance imaging (MRI) [ Time Frame: 2.5 years ]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.
- Extent of amyloid deposition as measured by Florbetapir F 18: Datum of these scans will be collected via standardized uptake value ratios (SUVR) normalized to the cerebellum [ Time Frame: 2.5 years ]
- 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: 2.5 years ]Data from participants will be entered into the NIH Genome-Wide database and made available to the scientific community.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434393
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Director:||Rema Raman, PhD||USC Alzheimer's Therapeutic Research Institute|
|Study Director:||Scott Mackin, PhD||University of California, San Francisco|