Multicenter Evaluation of Memory Remediation After TBI With Donepezil

Summary

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.

Conditions

• Traumatic Brain Injury
• Memory Deficits

Interventions

DRUG

Donepezil

Donepezil 5 mg capsule daily for 14 days. Donepezil 10 mg capsule daily for 56 days.

DRUG

Placebo

Placebo capsule once daily for 70 days.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital

  collaborator OTHER

• Albert Einstein Healthcare Network

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Craig Hospital

  collaborator OTHER

• TIRR Memorial Hermann

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• David Arciniegas, MD · TIRR Memorial Hermann/Baylor College of Medicine

• Angelle Sander, PhD · TIRR Memorial Hermann/Baylor College of Medicine

• Joseph Giacino, PhD · Spaulding Rehabilitation Hospital

• Tessa Hart, PhD · Moss Rehabilitation Research Institute

• Flora Hammond, MD · Indiana University

• Mark S Sherer, PhD · TIRR Memorial Hermann

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-01

Primary Completion

2024-12-04

Completion

2024-12-04

Countries

• United States

Study Locations