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Cholinesterase Inhibitor
Enhancing Rehabilitation After Stroke (Enhance Trial)
Phase 3
Waitlist Available
Led By Ellen M Whyte, MD
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
This trial tests if donepezil, a medication that helps with memory and thinking, can improve recovery in older stroke survivors with cognitive impairments during rehabilitation. It works by boosting brain chemicals important for memory and thinking. Donepezil has been used to treat cognitive impairments in various conditions, including Alzheimer's disease, traumatic brain injury, and vascular dementia.
Eligible Conditions
- Stroke
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2008 Phase 4 trial • 22 Patients • NCT0048200145%
frequent urination
18%
fatigue / somnolence
18%
headaches / abnormal dreams
9%
nausea / diarrhea
9%
insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donepezil
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1: donepezilExperimental Treatment1 Intervention
Participants will receive treatment for 12 weeks on donepezil 10 mg (or 5 mg if unable to tolerate 10 mg). Treatment will be then be terminated and participants followed for another 12 weeks naturalistically.
Group II: 2. placeboPlacebo Group1 Intervention
Participants will receive treatment for 12 weeks with placebo pill. Treatment will be then be terminated and participants followed for another 12 weeks naturalistically.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donepezil
FDA approved
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
2,068 Previous Clinical Trials
2,747,507 Total Patients Enrolled
86 Trials studying Stroke
5,563 Patients Enrolled for Stroke
Ellen M Whyte, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
224 Total Patients Enrolled
1 Trials studying Stroke
154 Patients Enrolled for Stroke