Status:
COMPLETED
Multicenter Evaluation of Memory Remediation After TBI With Donepezil
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Spaulding Rehabilitation Hospital
Albert Einstein Healthcare Network
Conditions:
Traumatic Brain Injury
Memory Deficits
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 r...
Detailed Description
BACKGROUND: Memory deficits are among the most common chronic and functionally important consequences of traumatic brain injury (TBI). Basic and clinical research studies suggest that persistent defic...
Eligibility Criteria
Inclusion
- Man or woman of any race, color, ethnicity, or national origin
- 18-60 years old
- Primary language English
- Clinical diagnosis of traumatic brain injury using National Institute of Neurological Disorders and Stroke TBI Common Data Elements definition and merit assignment of International Classification of Disease (ICD9) codes 850.0-850.9, 851.0, 851.2, 852.0, 852.2, 852.4, 853.0, or 854.0
- TBI is non-penetrating
- TBI is of complicated mild or greater severity
- TBI occurred at least 6 months prior to study participation
- Persistent posttraumatic memory impairment, as defined by HVLT-R Total Trials 1-3 (Form 3) impairment ≥ 25% for Wechsler Test of Adult Reading-based intelligence quotient-adjusted performance expectations
- Memory impairments are functionally significant, as defined by subject and/or caregiver endorsement of at least 3 memory problems, occurring at least weekly, on the Everyday Memory Questionnaire
- Stable doses of allowed centrally-acting medications for at least 3 months prior to study participation, and participant and caregiver commitment not to alter doses of allowed medications during study
- 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
- A knowledgeable informant is available and willing to attend study visits or to provide required information by telephone interview on the day of study visits
Exclusion
- Pre-injury neurological and/or neurocognitive disorder
- Primary diagnosis of hypoxic-ischemic brain injury or clinically definite post-TBI hypoxic-ischemic event (i.e., respiratory arrest and/or cardiac arrest) or non-TBI-related stroke
- Pre- or post-injury psychotic and/or bipolar disorders
- Post-injury substance use disorder (i.e., abuse or dependence diagnoses)
- Clinically significant abnormalities on screening laboratory studies
- Beck Depression Inventory-II (BDI-II) score ≥ 20 or BDI-II item 9 \> 0
- Brief Symptom Inventory 18 (BSI 18) Depression Subscale T score or Anxiety Subscale T score ≥ 63
- Penetrating brain injury or cerebral lobectomy
- Hearing, vision, and/or communication impairments that invalidate neuropsychological or other study assessments
- Test of Memory Malingering Trial 2 score \< 45
- Use of an excluded medication in the month prior to study participation, known allergy to donepezil, or documented intolerance to donepezil
- Posttraumatic epilepsy
- Symptomatic bradycardia, cardiac conduction abnormality (i.e., first- or Type I second-degree atrioventricular blockade), atrial fibrillation, or unstable cardiovascular disease, including myocardial infarction within three months prior to study participation
- Active, severe, or unstable pulmonary condition, including severe asthma
- Signs or symptoms of gastrointestinal bleeding or active peptic ulcer disease within three months prior to study participation
- Serum human chorionic gonadotropin (HCG)-confirmed pregnancy
- For female participants, unable/unwilling to use barrier contraception during study participation, intrauterine device, or other implantable contraceptive method, unable/unwilling to forego breastfeeding infants or children during study participation
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02255799
Start Date
September 1 2013
End Date
December 4 2024
Last Update
January 15 2025
Active Locations (4)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129
3
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, United States, 19027
4
TIRR Memorial Hermann
Houston, Texas, United States, 77030