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)
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Sheppard Pratt Health System
Baltimore, Maryland, United States
Change from Baseline Clinical Global Impression Scale (CGI) to two weeks after medication administration
Time frame: Up to 2 weeks
Change from Baseline TBI-QoL to two weeks after medication administration
Questions from the TBI-QoL battery, which consists of tests to assess items on domains of emotion, social activity, physical activity, and cognition
Time frame: Up to 2 weeks
Change from Baseline NIH Toolbox Cognition Battery to two weeks after medication administration
A cognition battery developed by NIH, which consists of tests to assess Executive Function, Attention, Episodic Memory, Language, Processing Speed and Working Memory.
Time frame: Up to 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.