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Multicenter Evaluation of Memory Remediation in Traumatic Brain Injury With Donepezil: A Randomized Controlled Trial.

David B Arciniegas1, Emily J Almeida1, Angelle M Sander1

  • 1Behavioral Neurology Section, Department of Neurology, University of Colorado School of Medicine, Aurora (Arciniegas); Brain Injury Research Center, TIRR Memorial Hermann, Houston (Arciniegas, Sander, Sherer); H. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston (Arciniegas, Sander, Bogaards, Sherer); Research Department, Craig Hospital, Englewood, Colo. (Almeida, Harrison-Felix, Ketchum, Mellick); Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Charlestown, Mass. (Giacino, Zafonte); Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston (Giacino, Zafonte); Rehabilitation Hospital of Indiana, Indianapolis (Hammond); Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine, Indianapolis (Hammond); Moss Rehabilitation Research Institute, Elkins Park, Pa. (Hart, Whyte); Department of Rehabilitation Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia (Hart).

The Journal of Neuropsychiatry and Clinical Neurosciences
|December 4, 2024
PubMed
Summary

Donepezil significantly improved verbal memory in patients with traumatic brain injury (TBI). This acetylcholinesterase inhibitor showed efficacy for persistent memory deficits, with a favorable safety profile for TBI recovery.

Keywords:
Acetylcholinesterase InhibitorCognitionDonepezilMemoryRandomized Controlled TrialTraumatic Brain Injury

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Area of Science:

  • Neuroscience
  • Clinical Neurology
  • Pharmacology

Background:

  • Memory impairments are a significant consequence of traumatic brain injury (TBI).
  • Cholinergic deficits following TBI can lead to persistent verbal memory problems.
  • Donepezil, an acetylcholinesterase inhibitor, is a potential therapeutic agent for these deficits.

Purpose of the Study:

  • To evaluate the efficacy and safety of donepezil in treating verbal memory impairments after TBI.
  • To assess the impact of donepezil on cognitive, neuropsychiatric, and functional outcomes in TBI survivors.
  • To determine the treatment-responder rates and tolerability of donepezil in this population.

Main Methods:

  • A randomized, double-blind, placebo-controlled, 10-week clinical trial (MEMRI-TBI-D study) involving 75 participants.
  • Participants had persistent verbal memory problems at least 6 months post-TBI.
  • Efficacy was measured using the Hopkins Verbal Learning Test-Revised, alongside safety and tolerability assessments.

Main Results:

  • Donepezil significantly improved verbal learning (primary outcome) compared to placebo.
  • Treatment-responder rates were 42% for donepezil versus 18% for placebo (NNT=3.5).
  • Donepezil responders showed improvements in delayed recall and processing speed; common adverse events included diarrhea and nausea (NNH=6.25).

Conclusions:

  • Donepezil is an effective treatment for severe, persistent memory impairments following TBI.
  • The drug demonstrates a relatively favorable safety and tolerability profile in this patient group.
  • Donepezil offers a potential therapeutic option for improving cognitive function and quality of life after TBI.