NCT02255799: MEMRI-TBI-D

Multicenter Evaluation of Memory Remediation After TBI With Donepezil

Completed Phase 3 Last updated 15 January 2025

What this trial tests

Phase 3 trial testing Donepezil in Traumatic Brain Injury in 75 participants. Completed in 4 December 2024.

Timeline

1 September 2013

Primary endpoint
4 December 2024

4 December 2024

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	75
Start date	1 September 2013
Primary completion	4 December 2024
Estimated completion	4 December 2024
Sites	4 locations across United States

Drugs / interventions tested

• Donepezil (DONEPEZIL) — full drug profile →
• Placebo

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• Memory Deficits — all drugs for Memory Deficits →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 60, any sex, with Traumatic Brain Injury or Memory Deficits. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a four-site, randomized, parallel design, double-blind, placebo-controlled, 10-week trial of donepezil 10 mg daily for verbal memory problems among adults with TBI in the subacute or chronic recovery period. The study will recruit 160 persons with TBI and functionally important memory problems during a four-year period of open recruitment.

The study aims are:

1. To evaluate the effects of treatment with donepezil on verbal memory as assessed by the Hopkins Verbal Learning Test-Revised Total Trial 1-3;
2. To evaluate the effects of treatment with donepezil on memory-related activities as measured by the Everyday Memory Questionnaire;
3. To evaluate the effects of donepezil on attention, processing speed, neuropsychiatric symptoms, community participation, quality of life, and caregiver experiences.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Clinical Trials in Traumatic Brain Injury.
   Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527
2. Traumatic brain injury and immunological outcomes: the double-edged killer.
   Datta S, Lin F, Jones LD, Pingle SC, et al · · 2023 · cited 10× · PMID 37228857 · DOI 10.2144/fsoa-2023-0037