NCT02652598

Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD

A Proof of Concept Open-label Study to Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With Traumatic Brain Injury (TBI), Other Acquired Brain Injuries (ABI), or a Diagnosis of Neurocognitive Disorder (NCD)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sheppard Pratt Health System · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Brain Injuries, Traumatic
• Neurocognitive Disorders
• Brain Injuries

Interventions

Type	Name	Description
DRUG	Tolcapone

Timeline

• Start date: 2015-11-01
• Primary completion: 2020-01-01
• First posted: 2016-01-12
• Last updated: 2017-01-19

Locations

1 site across 1 country: United States