Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project
NCT ID: NCT02434393
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2015-03-04
2027-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Late Life Depression
120 participants who meet the criteria for Major Depression or Late Life Depression (LLD)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, San Francisco
OTHER
Alzheimer's Therapeutic Research Institute
OTHER
University of Southern California
OTHER
Responsible Party
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Paul S. Aisen
Professor
Principal Investigators
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Scott Mackin, PhD
Role: STUDY_DIRECTOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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References
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Lyness JM, Niculescu A, Tu X, Reynolds CF 3rd, Caine ED. The relationship of medical comorbidity and depression in older, primary care patients. Psychosomatics. 2006 Sep-Oct;47(5):435-9. doi: 10.1176/appi.psy.47.5.435.
McCusker J, Cole M, Ciampi A, Latimer E, Windholz S, Belzile E. Major depression in older medical inpatients predicts poor physical and mental health status over 12 months. Gen Hosp Psychiatry. 2007 Jul-Aug;29(4):340-8. doi: 10.1016/j.genhosppsych.2007.03.007.
Gabryelewicz T, Styczynska M, Luczywek E, Barczak A, Pfeffer A, Androsiuk W, Chodakowska-Zebrowska M, Wasiak B, Peplonska B, Barcikowska M. The rate of conversion of mild cognitive impairment to dementia: predictive role of depression. Int J Geriatr Psychiatry. 2007 Jun;22(6):563-7. doi: 10.1002/gps.1716.
Rapp MA, Gerstorf D, Helmchen H, Smith J. Depression predicts mortality in the young old, but not in the oldest old: results from the Berlin Aging Study. Am J Geriatr Psychiatry. 2008 Oct;16(10):844-52. doi: 10.1097/JGP.0b013e31818254eb.
Ganzini L, Smith DM, Fenn DS, Lee MA. Depression and mortality in medically ill older adults. J Am Geriatr Soc. 1997 Mar;45(3):307-12. doi: 10.1111/j.1532-5415.1997.tb00945.x.
Related Links
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National Institute of Mental Health
Laboratory of Neuro Imaging
Alzheimer's Therapeutic Research Institute
Related Info
Other Identifiers
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ADC-048
Identifier Type: -
Identifier Source: org_study_id
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