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Cholinesterase Inhibitor

1: donepezil for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2008 Phase 4 trial • 22 Patients • NCT00482001

45%

frequent urination

18%

fatigue / somnolence

18%

headaches / abnormal dreams

nausea / diarrhea

insomnia

100%

80%

60%

40%

20%

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

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