Alzheimer's Disease Neuroimaging Initiative 2

Inclusion Criteria

• •General (applies to each category):
• •Geriatric Depression Scale less than 6.
• •Age between \*55-90 (inclusive). \*For normal controls and SMC participants, age must be between 65-90.
• •Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol.
• •Visual and auditory acuity adequate for neuropsychological testing.
• •Good general health with no diseases expected to interfere with the study.
• •Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
• •Willing and able to participate in a longitudinal imaging study.
• •Hachinski less than or equal to 4.
• •Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
• •Must speak English or Spanish fluently.
• •Willing to undergo repeated MRIs (3Tesla) and at least two PET scans (one FDG and one Amyloid imaging) and no medical contraindications to MRI.
• •Agrees to collection of blood for Genome Wide Association Studies (GWAS), APOE testing and DNA and RNA banking.
• •Agrees to collection of blood for biomarker testing.
• •Agrees to at least one lumbar puncture for the collection of CSF.
• •Participant must be free of memory complaints, verified by a study partner.
• •Normal memory function score on Wechsler Memory Scale (adjusted for education)
• •Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
• •Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
• •Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
• •Stability of Permitted Medications for 4 weeks. In particular, participants may take:
• •* Antidepressants lacking significant anticholinergic side effects
• •* Estrogen replacement therapy is permissible
• •* Gingko biloba is permissible, but discouraged
• •* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• •Subjects that are "self-referrals" that have a significant subjective memory concern
• •Significant memory concern confirmed by a Cognitive Change Index score of more than or equal to 16
• •Normal memory function score on Wechsler Memory Scale (adjusted for education)
• •Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
• •Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
• •Cognitively normal, based on the absence of significant memory impairment in cognitive function or activities of daily living
• •Stability of Permitted Medications for 4 weeks. In particular, subjects may take:
• •* Antidepressants lacking significant anticholinergic side effects
• •* Estrogen replacement therapy is permissible
• •* Gingko biloba is permissible, but discouraged
• •* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• •Participant must have a subjective memory concern as reported by participant, study partner, or clinician
• •Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
• •Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
• •Clinical Dementia Rating (CDR) = 0.5; Memory Box score must be at least 0.5
• •General cognition and functional performance sufficiently preserved such that a diagnosis of AD cannot be made by the site physician at the time of the screening visit
• •Stability of Permitted Medications for 4 weeks. In particular, participants may take:
• •* Antidepressants lacking significant anticholinergic side effects
• •* Estrogen replacement therapy
• •* Gingko biloba is permissible, but discouraged
• •* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• •* Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening
• •Participant must have a subjective memory concern as reported by participant, study partner, or clinician
• •Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
• •Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive)
• •Clinical Dementia Rating (CDR) = 0.5 or 1.0
• •National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
• •Stability of Permitted Medications for 4 weeks. In particular, participants may take:
• •* Antidepressants lacking significant anticholinergic side effects
• •* Estrogen replacement therapy
• •* Gingko biloba is permissible, but discouraged
• •* Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• •* Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening
• •Must have been enrolled and followed in ADNI1 for at least one year or enrolled in ADNI-GO with original diagnosis of Cognitively Normal (CN), Mild Cognitive Impairment (MCI), or Early Mild Cognitive Impairment (EMCI) regardless of whether a diagnostic conversion has occurred since initial enrollment in ADNI.
• •Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery.
• •Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol.