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

Active, not recruiting

This observational study will characterize the biological mechanisms contributing to cognitive impairment and decline in older adults with depression. No treatment will be tested or given.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years N/A Both No
February 2015
January 2021
120

  • Current DSM-IV diagnosis of major depressive disorder, unipolar type, without psychotic features, of at least 6 weeks' duration
  • English speaking
  • Hamilton Depression Rating Scale score of ≥15
  • Willing to undergo magnetic resonance imaging (MRI) and positron emission tomography (PET) brain scans; able to fit comfortably in an MRI machine
  • Agrees to collection of blood for genetic and biomarker testing, assays, and telomere length measurement
  • Seeing and hearing ability adequate for neuropsychological testing
  • Completed six grades of education or has established work history sufficient to exclude mental retardation
  • Available study partner who has frequent contact with participant (average of 10 or more hours per week) and can accompany him or her to clinical visits

  • Current diagnosis of other axis 1 psychiatric disorders, with the exception of simple phobias and generalized anxiety disorder
  • Evidence of dementia (MMSE score <25)
  • Any electroconvulsive therapy within the past 6 months
  • Undergoing antidepressant or psychotherapy treatment
  • Any significant neurological diseases, such as Parkinson's disease, epilepsy, cortical stroke, or traumatic brain injury
  • History of alcohol or substance abuse or dependence within the past 2 years
  • Any active and serious suicidal ideation
  • Any significant systemic illness or unstable medical condition that could lead to difficulty complying with study procedures
  • History of surgical procedures effecting study outcomes
  • Residence in skilled nursing facility
  • Participation in clinical studies involving the same neuropsychological measures used in ADNI-D
  • Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the subject in any given year would exceed federal limits; known history of MRI scans with evidence of infection, infarction, or other focal lesions; multiple lacunes or lacunes in a critical memory structure; presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin or body, claustrophobia
  • Pregnant, lactating, or of childbearing potential (women must be 2 years post-menopausal or surgically sterile)

Participants who meet criteria for major depression or late-life depression will be enrolled for 30 months. Depression history, symptom severity, and health information will be collected at the initial psychiatric visit to determine eligibility. An MRI brain scan and florbetapir (18F-AV-45) PET amyloid imaging will be conducted at clinic site visits. Blood samples for biomarkers, clinical assessments, cognitive assessments, and genetic analysis will be collected at two time points. Data from an additional 300 non-depressed subjects will be used for comparison.

Name City State Zip Status Primary Contact
University of California, San Francisco
San Francisco California 94143 David Bickford
415-476-7046
david.bickford@ucsf.edu,
University of Pittsburgh
Pittsburgh Pennsylvania 15213 Michelle Zmuda
412-246-6487
zmudamd@upmc.edu

Alzheimer's Therapeutic Research Institute

  • National Institute of Mental Health (NIMH)
  • University of California, San Francisco
  • University of Southern California

Name Role Affiliation
Paul S. Aisen, MD Study Director University of Southern California, Alzheimer's Therapeutic Research Institute
Scott Mackin, PhD Study Director University of California, San Francisco

Name Phone Email
David Bickforth 415-476-7046 david.bickford@ucsf.edu

NCT02434393

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