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Summary

Eligibility
for people ages 65 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Major Depression Late Life Depression (LLD) Depression Late Life Depression LLD amyloid imaging biomarkers

Eligibility

You can join if…

Open to people ages 65 years and up

  1. Current DSM-IV diagnosis of Major Depressive Disorder, unipolar type, without psychotic features and six week minimum duration of current depressive episode.
  2. English Speaking
  3. 65+ years of age
  4. Hamilton Depression Rating Scale score ≥ 15
  5. Able to give informed consent
  6. Willing to undergo one MRI (3 Tesla) and one PET scan (Amyloid imaging)
  7. Able to fit in an MRI machine comfortably (BMI ≤ 38)
  8. Agrees to collection of blood for GWAS, apolipoprotein E (APOE) testing and DNA and RNA testing
  9. Agrees to collection of blood for biomarker testing
  10. Agrees to collection of additional blood sample for to-be-determined assays and telomere length measurement
  11. Visual and auditory acuity adequate for neuropsychological testing
  12. Completed six grades of education or has established work history (sufficient to exclude mental retardation)
  13. Study partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to clinical visits for the duration of the protocol.

You CAN'T join if...

  1. Current diagnosis of other axis 1 psychiatric disorders (with the exception of Simple Phobias and Generalized Anxiety Disorder)
  2. Evidence of Dementia (MMSE <25)
  3. Any electroconvulsive therapy within the past 6 months
  4. Undergoing anti-depressant or psychotherapy treatment (exceptions listed 4.3.Treatment Exclusion Exceptions)
  5. Any significant neurological diseases (i.e. Parkinson's disease, epilepsy, cortical stroke, traumatic brain injury)
  6. History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria)
  7. Any active and serious suicidal ideation, including ideation, plan and intent to carry out that plan, as assessed by the Hamilton Depression Rating Scale (HDRS)
  8. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
  9. History of surgical procedures effecting study outcomes
  10. Residence in skilled nursing facility
  11. Participation in clinical studies involving the same neuropsychological measures used in ADNI-D that may impact study outcomes
  12. Investigational agents are prohibited one month prior to entry and for the duration of the trial
  13. Exclusion for amyloid imaging with florbetapir: 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 the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1
  14. Known history of MRI scans with evidence of infection, infarction, or other focal lesions. Subjects with multiple lacunes or lacunes in a critical memory structure are excluded
  15. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia
  16. Pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)

Locations

  • University of Pittsburgh accepting new patients
    Pittsburgh, Pennsylvania, 15213, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Southern California
Links
National Institute of Mental Health
Laboratory of Neuro Imaging
Alzheimer's Therapeutic Research Institute
ID
NCT02434393
Study Type
Observational
Last Updated
November 1, 2016
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