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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 |
|---|---|---|
|
Cognitive Impairment |
Drug: Aricept |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| 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
| Study ID Numbers: | E2020-A001-233 |
| Study First Received: | February 17, 2005 |
| Last Updated: | October 3, 2007 |
| ClinicalTrials.gov Identifier: | NCT00103948 History of Changes |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cognition Disorders |