Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study (Alzheimer's)
Alzheimer's Disease
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring [18F]AV-45 PET amyloid binding imaging, Alzheimer's disease
Eligibility Criteria
Inclusion Criteria:
Enrolled subjects will be between 55-90 (inclusive) years of age, at least 6 years of formal education, and have a study partner able to provide an independent evaluation of functioning. All subjects must be willing and able to undergo all test procedures including neuroimaging and agree to longitudinal follow up. Specific psychoactive medications will be excluded. General inclusion/exclusion criteria are as follows:
- Normal subjects: MMSE scores between 24-30 (inclusive), a CDR of 0, non-depressed, non-MCI, and nondemented, education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years:≥9; 6-15 years: ≥5).
- EMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: 9-11; 6-15 years: 5-9), a CDR sum of box of 0.5 (0.5 only in memory subdomain), absence of significant levels of impairment in other cognitive domains, essentially preserved activities of daily living, and an absence of dementia.
- LMCI subjects: MMSE scores between 24-30(inclusive), a memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4), a CDR of 0.5 with a mandatory requirement of the memory box score being 0.5 or greater, essentially preserved activities of daily living, and an absence of dementia.
- Mild AD: MMSE scores between 20-26 (inclusive), CDR of 0.5 or 1.0, and meets NINCDS/ADRDA criteria for probable AD, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory III story A delayed recall scores (education ≥16 years: ≤8; 6-15 years: ≤4)
Exclusion criteria:
Subjects taking antidepressant medications with anticholinergic properties will be excluded, and the regular use of narcotic agents have to be limited to < 2 doses per week within 4 weeks of screening. Neuroleptic medications and other drugs with anticholinergic properties, anti-parkinsonian medications are not allowed within 4 weeks of screening. Diuretic drugs should not be started or need to be discontinued 4 weeks prior to screening. Cholinesterase inhibitors and memantine are permitted if the doses are stable for 4 weeks prior to screening for subjects with MCI and AD. Estrogen and estrogen-like compounds and vitamin E are allowed if the dose have been stable for 4 weeks prior to screening. Participants are required to report any medication changes to the site investigators once they are enrolled in the study.
Sites / Locations
- Tzu-Chen-YenRecruiting
Arms of the Study
Arm 1
Experimental
F18-AV45