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Acetylcholinesterase Inhibitor

Donepezil for Memory Loss after Traumatic Brain Injury (MEMRI-TBI-D Trial)

Phase 3
Waitlist Available
Led By Mark S Sherer, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of traumatic brain injury using specific criteria
Traumatic brain injury of complicated mild or greater severity
Must not have
Posttraumatic epilepsy
Active, severe, or unstable pulmonary condition, including severe asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study week 0, 6, and 10
Awards & highlights
Pivotal Trial

Summary

This trial will test whether donepezil improves verbal memory in people with TBI.

Who is the study for?
Adults aged 18-60 with non-penetrating traumatic brain injury (TBI) that happened at least 6 months ago, who now have memory problems but are stable on certain medications. They must speak English and be able to consent or have a representative consent for them. A knowledgeable person must be available to help with the study.
What is being tested?
The trial is testing if donepezil, taken daily for 10 weeks, helps improve verbal memory in adults with TBI compared to a placebo. The effects on attention, processing speed, neuropsychiatric symptoms, community participation, quality of life and caregiver experiences will also be studied.
What are the potential side effects?
Donepezil may cause side effects like nausea, diarrhea, insomnia, muscle cramps, fatigue and abnormal dreams. It might also lead to more serious heart-related issues such as slow heartbeat or fainting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a traumatic brain injury.
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I have had a serious head injury.
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I have had a brain injury without an object going through my skull.
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have epilepsy caused by a previous injury.
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I do not have severe or uncontrolled lung problems.
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I have heart rhythm problems or unstable heart disease.
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I have been diagnosed with brain injury due to lack of oxygen.
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I haven't taken any excluded medications in the last month and I'm not allergic to donepezil.
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I have had a penetrating brain injury or part of my brain removed.
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I cannot or choose not to use certain birth control methods or stop breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study week 0, 6, and 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and study week 0, 6, and 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Trials 1-3
Secondary study objectives
Caregiver Measures
Cognitive Measures
Functional Measures
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DonepezilActive Control1 Intervention
Donepezil 5 mg capsules daily for 14 days. Donepezil 10 mg capsules daily for 56 days.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules once daily for 70 days.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,350 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
139 Previous Clinical Trials
10,941 Total Patients Enrolled
Albert Einstein Healthcare NetworkOTHER
64 Previous Clinical Trials
868,549 Total Patients Enrolled
~13 spots leftby Nov 2025
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