Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project
a study on Depression Alzheimer's Disease Neuroimaging
Summary
- Eligibility
- for people ages 65 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedcompletion around
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, Depressive Disorder, Cognitive Dysfunction
Eligibility
You can join if…
Open to people ages 65 years and up
- Current DSM-IV diagnosis of Major Depressive Disorder, unipolar type, without psychotic features and six week minimum duration of current depressive episode.
- English Speaking
- 65+ years of age
- Hamilton Depression Rating Scale score ≥ 15
- Able to give informed consent
- Willing to undergo one MRI (3 Tesla) and one PET scan (Amyloid imaging)
- Able to fit in an MRI machine comfortably (BMI ≤ 38)
- Agrees to collection of blood for GWAS, apolipoprotein E (APOE) testing and DNA and RNA testing
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...
- Current diagnosis of other axis 1 psychiatric disorders (with the exception of Simple Phobias and Generalized Anxiety Disorder)
- Evidence of Dementia (MMSE <25)
- Any electroconvulsive therapy within the past 6 months
- Undergoing anti-depressant or psychotherapy treatment (exceptions listed 4.3. Treatment Exclusion Exceptions)
- Any significant neurological diseases (i.e. Parkinson's disease, epilepsy, cortical stroke, traumatic brain injury)
- History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria)
- 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)
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
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 California, San Francisco
San Francisco California 94143 United States - University of Pittsburgh
Pittsburgh Pennsylvania 15213 United States
Details
- Status
- in progress, not 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
- Participants
- About 133 people participating
- Last Updated