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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
Traumatic brain injury occurred at least 6 months prior to study participation
Capable of providing independent informed consent for study participation or provision of consent for study participation by a legally-authorized representative is supported by subject assent to study participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study week 0, 6, and 10
Awards & highlights

MEMRI-TBI-D 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.Check my eligibility
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.See study design
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.

MEMRI-TBI-D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My traumatic brain injury happened over 6 months ago.
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I can give my own consent or have someone legally authorized to do so on my behalf.
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I have been diagnosed with a traumatic brain injury.
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I've been on the same dose of my brain-related medication for at least 3 months.
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My gender or ethnicity does not limit my participation.
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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.

MEMRI-TBI-D Trial 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

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

MEMRI-TBI-D 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
997 Previous Clinical Trials
6,001,859 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
133 Previous Clinical Trials
10,863 Total Patients Enrolled
Albert Einstein Healthcare NetworkOTHER
63 Previous Clinical Trials
868,462 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the research landscape surrounding Donepezil?

"There are a total of 16 ongoing clinical trials investigating Donepezil. 3 of those live trials are currently in Phase 3 testing. Many of the trials for Donepezil are based in Hallandale Beach, Florida, but there are 31 research locations running these tests across the United States."

Answered by AI

Will this research be conducted with elderly participants?

"According to the inclusion criteria for this study, patients aged 18 to 60 are eligible to apply. There are 72 studies currently being conducted involving patients under 18 and 291 studies being done with elderly patients."

Answered by AI

Are we still recruiting participants for this experiment?

"As of now, this trial is not looking for any more participants. According to the clinicaltrial.gov website, the last edit was on September 20th, 2022. If you are interested in other studies, there are currently 371 trials actively recruiting patients with memory disturbances and 16 trials for Donepezil that have open enrollment."

Answered by AI

How can I become a test subject for this research?

"This trial is designed for 160 patients that are experiencing memory issues and fall in the age range of 18 to 60 years old."

Answered by AI

Why is Donepezil commonly given to patients?

"Donepezil is frequently used to help patients with alzheimer's disease, but it can also be useful for those struggling with mild dementia of the Alzheimer's type, vascular dementia, and general dementia."

Answered by AI

What is the FDA's official opinion on Donepezil?

"There is both animal and human data supporting Donepezil's safety, so it received a score of 3."

Answered by AI

In how many different medical clinics is this research project being conducted today?

"There are 4 sites for this clinical trial, all of which are listed below. It is essential that patients select the clinic nearest to them in order to reduce travel-related burdens. -Charlestown -Elkins Park -Houston"

Answered by AI

How many test subjects are enrolled in this experiment?

"As of September 20th, 2022, this trial is no longer seeking patients. It was initially posted on October 1st, 2013. If you are interested in other studies, 371 trials for memory disturbances and 16 for Donepezil are still looking for participants."

Answered by AI

Does this trial break new ground in the medical field?

"Since 2013, when the first trial for Donepezil was completed, there has been significant global interest in this medication. Dong-A Pharmaceutical Co., Ltd. sponsored the original study which had 210 participants. After successful completion of Phase 3 trials, today there are 16 active clinical trials being conducted across 7 countries and 21 cities."

Answered by AI
~2 spots leftby Jun 2024