Multicenter Evaluation of Memory Remediation After TBI With Donepezil (MEMRI-TBI-D)
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|ClinicalTrials.gov Identifier: NCT02255799|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2014
Last Update Posted : January 30, 2020
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:
- To evaluate the effects of treatment with donepezil on verbal memory as assessed by the Hopkins Verbal Learning Test-Revised Total Trial 1-3;
- To evaluate the effects of treatment with donepezil on memory-related activities as measured by the Everyday Memory Questionnaire;
- To evaluate the effects of donepezil on attention, processing speed, neuropsychiatric symptoms, community participation, quality of life, and caregiver experiences.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Memory Deficits||Drug: Donepezil Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||October 1, 2013|
|Actual Primary Completion Date :||January 13, 2020|
|Estimated Study Completion Date :||August 2, 2020|
Active Comparator: Donepezil
Donepezil 5 mg capsules daily for 14 days. Donepezil 10 mg capsules daily for 56 days.
Donepezil 5 mg capsule daily for 14 days. Donepezil 10 mg capsule daily for 56 days.
Placebo Comparator: Placebo
Placebo capsules once daily for 70 days.
Placebo capsule once daily for 70 days.
- Hopkins Verbal Learning Test-Revised (HVLT-R) Total Trials 1-3 [ Time Frame: study week 10 ]The effects of study treatment (donepezil or placebo) on persistent verbal memory impairments among persons with traumatic brain injury will be assessed by performance on HVLT-R Total Trials 1-3 at study week 10.
- Cognitive Measures [ Time Frame: study week 10 ]The effects of study treatment (donepezil or placebo) on attention, processing speed, and executive function among persons with persistent verbal memory impairments following TBI will be assessed using the Trail Making Test - Parts A and B; the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span, Symbol Search, Coding, Letter-Number Sequencing, and Processing Speed Index; and Controlled Oral Word Association Test at study week 10.
- Neuropsychiatric Measures [ Time Frame: study week 10 ]The effects of study treatment (donepezil or placebo) on neuropsychiatric symptoms among persons with persistent verbal memory impairments following TBI will be assessed by Brief Symptom Inventory 18 (BSI 18) - Global Severity Index and the Neuropsychiatric Inventory-Clinician version (NPI-C) Total and Domain scores at study week 10.
- Functional Measures [ Time Frame: study week 10 ]The effects of study treatment (donepezil or placebo) on functional status among persons with persistent verbal memory impairments will be assessed using participant and caregiver responses to the Everyday Memory Questionnaire, Participation Assessment with Recombined Tools-Objective, and Satisfaction with Life Scale scores at study week 10.
- Caregiver Measures [ Time Frame: study week 10 ]The effects of study treatment (donepezil or placebo) on distress among caregivers of persons with persistent verbal memory impairments will be assessed by the Caregiver Appraisal Scale - Perceived Burden Subscale as well as the NPI-C Caregiver Distress Scale scores at study week 10.
- Physical Measures [ Time Frame: study week 0, 6, and 10 ]The frequencies of adverse events associated with study treatment (donepezil or placebo) at study week 0, 6, and 10 will be assessed using the Side Effect Checklist.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255799
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Charlestown, Massachusetts, United States, 02129|
|United States, Pennsylvania|
|Moss Rehabilitation Research Institute|
|Elkins Park, Pennsylvania, United States, 19027|
|United States, Texas|
|TIRR Memorial Hermann|
|Houston, Texas, United States, 77030|
|Study Director:||David Arciniegas, MD||TIRR Memorial Hermann/Baylor College of Medicine|
|Principal Investigator:||Angelle Sander, PhD||TIRR Memorial Hermann/Baylor College of Medicine|
|Principal Investigator:||Joseph Giacino, PhD||Spaulding Rehabilitation Hospital|
|Principal Investigator:||Tessa Hart, PhD||Moss Rehabilitation Research Institute|
|Principal Investigator:||Flora Hammond, MD||Indiana University|
|Principal Investigator:||Mark S Sherer, PhD||TIRR Memorial Hermann|