|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
National Institute of Child Health and Human Development (NICHD) Department of Education |
| Information provided by: | National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00062972 |
Purpose
People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for improving memory and learning in individuals with Alzheimer’s disease.
| Condition | Intervention | Phase |
|
Multiple Sclerosis |
Drug: donepezil Drug: glucose |
Phase III |
| MedlinePlus related topics: | Memory Multiple Sclerosis |
| ChemIDplus related topics: | Dextrose Donepezil E 2020 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Interventions to Improve Memory in Patients With Multiple Sclerosis |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | August 2002 |
Cognitive dysfunction is one of the leading causes of disability in people with MS. Memory involving specific words (verbal memory) is particularly affected in individuals with MS. Attempts to rehabilitate cognitive dysfunction in MS have had only limited success.
This study will determine the efficacy of donepezil therapy and glucose administration for enhancing verbal memory functioning in individuals with MS. The study will also measure secondary outcomes assessing other areas of cognitive dysfunction (i.e., nonverbal memory, conceptual thinking, processing speed) which may improve with intervention.
Forty participants with MS will be randomly assigned to receive either donepezil or placebo for 24 weeks. Participants will complete memory and cognitive tests at the beginning and end of the 24 week period.
Twenty participants with MS will be randomly assigned to drink a beverage sweetened with either glucose or saccharin (placebo). Participants will then complete memory and other cognitive tests. Two weeks later, participants will drink a beverage sweetened with the alternative sweetener and again complete the memory and cognitive tests.
Eligibility
| Ages Eligible for Study: | 18 Years to 56 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| Contact: Patricia Melville, RN | 631-444-8164 | Pmelvill@neuro.som.sunysb.edu |
| United States, New York | |||||
| University Hospital and Medical Center | Recruiting | ||||
| Stony Brook, New York, United States, 11794-8121 | |||||
| Contact: Patricia Melville, RN 631-444-8164 Pmelvill@neuro.som.sunysb.edu | |||||
| National Institute of Child Health and Human Development (NICHD) |
| Department of Education |
| Principal Investigator: | Lauren B. Krupp, MD | Department of Neurology, University Hospital Medical Center |
More Information
| Study ID Numbers: | 1R01 HD38107-01 |
| First Received: | June 18, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00062972 |
| Health Authority: | United States: Federal Government |
|
|
|
|