Alzheimer Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin E and Donepezil HCL (Aricept) to Delay Clinical Progression From Mild Cognitive Impairment (MCI) to Alzheimer's Disease (AD)
The National Institute on Aging (NIA) is launching a nationwide treatment study targeting
individuals with mild cognitive impairment (MCI), a condition characterized by a memory
deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from
both dementia and normal age-related changes in memory. Accurate and early evaluation and
treatment of MCI individuals might prevent further cognitive decline, including development
of Alzheimer's disease (AD).
The Memory Impairment Study is the first such AD prevention clinical trial carried out by
NIH, and will be conducted at 65-80 medical research institutions located in the United
States and Canada. This study will test the usefulness of two drugs to slow or stop the
conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an
investigational agent approved by the Food and Drug Administration for another use. Vitamin
E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997
study to delay important dementia milestones, such as patients' institutionalization or
progression to severe dementia, by about seven months.
This clinical trial will be a multicenter, randomized, double-blind, placebo- controlled,
parallel-group study of vitamin E and donepezil in 720 subjects with mild cognitive
impairment (MCI). Subjects will be randomized to one of three treatment groups (240 subjects
per treatment group): 1) Placebo vitamin E and placebo donepezil plus a multivitamin daily.
2) Vitamin E (2,000 I) and placebo donepezil plus a multivitamin daily.3) Donepezil (10 mg)
and placebo vitamin E plus a multivitamin daily.
The study will be conducted over three years, with clinical evaluations every 3 months for
the first 6 months and then every 6 months. Subjects randomized to donepezil will start a
dose of 5 mg daily. Donepezil will be increased to 10 mg after six weeks. Subjects
randomized to vitamin E will start at 1,000 I daily. The dose of Vitamin E will be increased
to 2,000 I after six weeks. There will be a 12-month recruitment period. The primary
endpoint will be time to development of Probable or Possible AD according to NINCDS-ADRDA
criteria. Upon determination of a clinical diagnosis of AD, documentation will be sent to
the ADCS Coordinating Center and forwarded to the Central Review Committee for verification.
Upon verification, of conversion to diagnosis of AD, subjects will stop taking the donepezil
study medication or its corresponding placebo, without breaking the blind, and will be
offered open label donepezil at a scheduled visit one month after the prior diagnostic
visit. Donepezil will be offered to subjects who convert to AD until the subject completes
three years from the baseline visit. Based on an estimated incidence of AD of 15% per year,
the study has 85% power to detect a 33% or greater reduction in conversion to AD over 3
years. Secondary outcome measures will include change on the Alzheimer's Disease Assessment
Scale (ADAS-COG), the Neuropsychological Battery, the Mini-Mental State Exam (MMSE),
Clinical Dementia Rating Scale (CDR), the Global Deterioration Scale (GDS), ADCS- Activities
of Daily Living Inventory (ADCS-ADL), a Pharmacoeconomics scale, and a Quality of Life
scale. Compliance will be monitored through the measurement of alpha-tocopherol levels and
pill counts at each visit.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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