Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000173
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
1999-10-29
Brief Title:
Memory Impairment Study Mild Cognitive Impairment Study
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
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 Alzheimers Disease AD
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Alzheimers 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
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
Detailed Description:
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 2000 I and placebo donepezil plus a multivitamin daily3 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 1000 I daily The dose of Vitamin E will be increased to 2000 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 Alzheimers 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
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 1000 I daily The dose of Vitamin E will be increased to 2000 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 Alzheimers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3U01AG010483-08S2 | NIH | None | httpsreporternihgovquickSearch3U01AG010483-08S2 |