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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR ARICEPT

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Clinical Trials for Aricept

Trial ID Title Status Sponsor Phase Summary
NCT00000173 Memory Impairment Study (Mild Cognitive Impairment Study) Completed Alzheimer's Disease Cooperative Study (ADCS) Phase 3 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.
NCT00000173 Memory Impairment Study (Mild Cognitive Impairment Study) Completed National Institute on Aging (NIA) Phase 3 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.
NCT00004807 Study of the Pathogenesis of Rett Syndrome Completed Johns Hopkins University N/A OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.
NCT00004807 Study of the Pathogenesis of Rett Syndrome Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) N/A OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.
NCT00024531 Lipitor as a Treatment for Alzheimer's Disease Completed Pfizer Phase 2 The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
NCT00024531 Lipitor as a Treatment for Alzheimer's Disease Completed Institute for the Study of Aging (ISOA) Phase 2 The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
NCT00030979 Donepezil to Treat Dementia in Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 4 This study will evaluate the safety and effectiveness of donepezil (Aricept) for treating mild dementia in patients with Parkinson's disease. Donepezil is approved for treating patients with Alzheimer's disease, whose memory and cognition problems are similar to those of patients with Parkinson's disease who are affected by dementia. Donepezil prevents the breakdown of a chemical messenger called acetylcholine, which is involved in memory and other cognitive functions, and may improve cognition in patients. Patients 40 years of age and older with Parkinson's disease who have mild to moderate dementia may be eligible for this 6-month study. It involves 6 clinic visits of approximately 2 hours each, described below. Candidates will be screened for participation during Visit 1. - Visit 1 (screening visit): Study candidates will have a medical history, physical and neurological examinations, electrocardiogram (EKG), and possibly blood tests. They will also undergo neuropsychological testing (tests of memory, language, mood and, other brain functions) and fill out a quality of life questionnaire. Those enrolled will be randomly assigned to receive either donepezil (5 mg per day) or placebo-a look-alike pill with no active ingredients. After 4 weeks, the dose of donepezil will be increased to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do not tolerate the 5-mg dose will be taken off medication but will continue to be followed and tested. - Visit 2 (week 7): Patients will have a neurological examination and neuropsychological testing and will fill out a quality of life questionnaire. - Visit 3 (week 10): Patients will repeat the evaluations done during visit 2 and will stop taking the study medication. - Visit 4 (week 16): Patients will repeat the evaluations done during visit 2 and will have their study medication switched. That is, patients previously on placebo will be switched to donepezil, and patients who were taking donepezil will be switched to placebo. After 4 weeks, the dose of donepezil will be increased to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do not tolerate the 5-mg dose will be taken off medication but will continue to be followed and tested. - Visits 5 and 6 (weeks 23 and 26): Patients will repeat the evaluations done during visit 2. This study is being conducted at the National Institutes of Health, the University of Pennsylvania, and Northwestern University
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aricept

Condition Name

Condition Name for Aricept
Intervention Trials
Alzheimer's Disease 33
Alzheimer Disease 16
Healthy 13
Dementia 10
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Condition MeSH

Condition MeSH for Aricept
Intervention Trials
Alzheimer Disease 54
Dementia 23
Cognition Disorders 12
Parkinson Disease 9
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Clinical Trial Locations for Aricept

Trials by Country

Trials by Country for Aricept
Location Trials
United States 293
Canada 43
Japan 27
United Kingdom 22
Australia 17
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Trials by US State

Trials by US State for Aricept
Location Trials
California 21
Texas 18
Florida 17
Arizona 17
New York 15
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Clinical Trial Progress for Aricept

Clinical Trial Phase

Clinical Trial Phase for Aricept
Clinical Trial Phase Trials
Phase 4 27
Phase 3 18
Phase 2 34
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Clinical Trial Status

Clinical Trial Status for Aricept
Clinical Trial Phase Trials
Completed 79
Recruiting 17
Terminated 10
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Clinical Trial Sponsors for Aricept

Sponsor Name

Sponsor Name for Aricept
Sponsor Trials
Pfizer 18
Eisai Inc. 14
National Institute of Mental Health (NIMH) 7
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Sponsor Type

Sponsor Type for Aricept
Sponsor Trials
Industry 94
Other 73
NIH 21
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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Colorcon
Citi
Cerilliant
Moodys
Johnson and Johnson
Cantor Fitzgerald
Covington
US Army

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