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| Sponsor: | Eisai Limited |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00103948 |
Purpose
This is an 18-week, prospective, multi-center, randomized, double-blind, placebo-controlled, (1:1) parallel-group study.
| Condition | Intervention | Phase |
|---|---|---|
|
Impaired Cognition |
Drug: Aricept |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | An 18-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy, Safety, And Tolerability Of Donepezil HCl (E2020) In Patients With CADASIL Who Have Cognitive Impairment |
Eligibility| Ages Eligible for Study: | 25 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Peripheral vascular disease must have been stable for 12 weeks prior to Screening. No elective surgical procedures should be planned during the course of the study (e.g., hernia repair and bunion removal). Patient with diabetes must be stable as demonstrated by an HbA1c of <= 8.0% or a random serum glucose value of <= 170 mg/dL.
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Jose Biller, M.D. | |
| Maywood, Illinois, United States, 60152 | |
| United States, New York | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| Australia, South Australia | |
| Woodville, South Australia, Australia, 5011 | |
| Spain | |
| Malaga, Spain, 29010 | |
| Study Director: | Margaret Moline, Ph.D. | Eisai Inc. |
More Information
| ClinicalTrials.gov Identifier: | NCT00103948 History of Changes |
| Other Study ID Numbers: | E2020-A001-233 |
| Study First Received: | February 17, 2005 |
| Last Updated: | March 31, 2011 |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
|
CADASIL Cognition Disorders Dementia, Vascular Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Cerebral Arterial Diseases Intracranial Arterial Diseases Dementia Vascular Diseases Cardiovascular Diseases Genetic Diseases, Inborn |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |