Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project

Inclusion Criteria:

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.

Exclusion Criteria:

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)