Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD
- Conditions
- Neurocognitive DisordersBrain Injuries, TraumaticBrain Injuries
- Interventions
- Registration Number
- NCT02652598
- Lead Sponsor
- Sheppard Pratt Health System
- Brief Summary
The experimental design is an open-label two-week trial of tolcapone to evaluate which clinical domains are affected by tolcapone treatment and to identify "responders" to tolcapone treatment in the two subject groups (BI and NCD)
- Detailed Description
Each patient will receive a two-week specified dosing amount of tolcapone (100mg TID on Day 1; 200mg TID on Days 2-14). The patient will be instructed to take the study drug three times daily. Tolcapone will be tapered after Day 14 to avoid potential withdrawal reactions.
Clinical Instruments for patients:
* Question banks from large patient-reported outcome measure initiatives will be used and administered and used by computerized-adaptive tests (CATs). These include the TBI-QoL for patients with TBI and question banks from the patient-reported outcome measure information systems (PROMIS) and neurology quality of life measurement initiative (Neuro-QoL). Patients will answer questions related to their mobility, fatigue, pain interference, positive affect and well-being, depression, anxiety, anger and irritability, and emotional and behavioral dyscontrol.
* Clinical Global Impressions Scale
* Geriatric Depression Scale-15
* State-Trait Anxiety Inventory
* Hopkins Adult Reading Test
* Frontal Systems Behavior Scale
* Montreal Cognitive Assessment
* Trails A\&B
* Modified Wisconsin Card Sorting Test
* NIH Toolbox
* Perceptual Comparison Test
* Brief Test of Attention
* Hopkins Verbal Learning Test
* Brief Visuospatial Memory Test
* Calibrated Ideational Fluency Assessment
* Profile of Mood States
* Digit Span
Clinical Instruments for Informants:
* Neuropsychiatry Inventory
* Apathy evaluation scale
* Overt aggression scale
* Frontal Systems Behavior Scale
Laboratory Measures:
* Blood sample for genotyping
* Blood sample for assessing COMT activity.
* Blood sample for a laboratory profile including CBC, CMP, TSH, Hepatitis Panel (B and C), and RPR
* A urine analysis, urine drug screen, and a urine pregnancy test
* In addition for NCD patients: a blood sample for tests including Serum Calcium, B12, ESR, and C-reactive protein
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-Label Tolcapone Each patient will receive a two-week specified dosing amount of tolcapone (100mg TID on Day 1; 200mg TID on Days 2-14). The patient will be instructed to take the study drug three times daily. Tolcapone will be tapered after Day 14 to avoid potential withdrawal reactions.
- Primary Outcome Measures
Name Time Method Change from Baseline Clinical Global Impression Scale (CGI) to two weeks after medication administration Up to 2 weeks
- Secondary Outcome Measures
Name Time Method Change from Baseline NIH Toolbox Cognition Battery to two weeks after medication administration Up to 2 weeks A cognition battery developed by NIH, which consists of tests to assess Executive Function, Attention, Episodic Memory, Language, Processing Speed and Working Memory.
Change from Baseline TBI-QoL to two weeks after medication administration Up to 2 weeks Questions from the TBI-QoL battery, which consists of tests to assess items on domains of emotion, social activity, physical activity, and cognition
Trial Locations
- Locations (1)
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States