ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE 2 (ADNI2) PROTOCOL (ADC-039)

Study ID
STU 102010-017

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Jacqueline Rabb
214-648-9376
jackie.rabb@utsouthwestern.edu

Principal Investigator
Kyle Womack

Summary

aDni 2 is a 54 month, non-randomized, non-treatment, natural history study including subjects from the previous aDni 1 and aDni Go studies, as well as, a new group of normal Controls, Mild Cognitive impairment (late and early MCis), Significant Memory Concern (SMC) and early alzheimer's Dementia patient. all subjects will undergo PeT (both beta amyloid and FDG), MRi imaging, CSF analysis, blood biomarkers, neurological and neuropsychological examinations on a yearly basis, with new subjects enrolled under aDni 2 only undergoing the exams and MRi imaging at interim month 3/6 visits as well.

Participant Eligibility

Inclusion for Normal Controls (NC), Early Mild Cognitive Impaired (EMCI), Late Cognitive Impaired (LMCI), Significant memory Concern (SMC), and Alzheimer's Disease (AD):
1. - Subject must be free of memory complaints (NC)
- Subject must have a subjective memory concern (EMCI, LMCI, SMC, and AD)
2. - Normal memory function documented by scoring above education adjusted cutoffs on the
Logical Memory II subscale from the Wechsler Memory Scale xRevised (NC, SMC)
- Abnormal memory function documented by scoring within the education adjusted ranges on
the Logical Memory II subscale from the Wechsler Memory Scale xRevised (EMCI, LMCI &
AD)
3. - Mini-Mental State Exam score between 24 and 30 (inclusive) (NC, SMC, EMCI & LMCI)
- Mini-Mental State Exam score between 20 and 26 (inclusive) (AD)
4. - Clinical Dementia Rating = 0. Memory Box score must be 0 (NC, SMC)
Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5 (EMCI & LMCI)
Clinical Dementia Rating = 0.5 or 1.0 (AD)
5. - Cognitively normal, based on an absence of significant impairment in cognitive functions or
activities of daily living (NC, SMC)
General cognition and functional performance sufficiently preserved such that a diagnosis of
Alzheimer[Single Quote]s disease cannot be made by the site physician at the time of the screening
visit (EMCI & LMCI)

The following additional inclusion criteria apply to all diagnostic categories:
6. Stability of Permitted Medications for 4 weeks
7. Geriatric Depression Scale less than 6.
8. Age between 55-90 (inclusive).
9. 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 all clinic visits for the duration of the protocol.
10. Visual and auditory acuity adequate for neuropsychological testing.
11. Good general health with no diseases expected to interfere with the study.
12. Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
13. Willing and able to participate in a longitudinal imaging study.
14. Hachinski less than or equal to 4.