Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sheppard Pratt Health System
Collaborator:
Lieber Institute for Brain Development (LIBD)
Treatments:
Tolcapone
Criteria
TBI and ABI Patients Inclusion Criteria

- Age 18-70

- Diagnosis of mild, moderate, or severe TBI, or history of ABI with classification to
be made based on parameters at the time of the index event or acquired brain injury.

- Index event resulting in Traumatic or Acquired Head Injury occurred >12 months prior
to trial initiation

- A current or former patient at the clinics of the Sheppard Pratt Neuropsychiatry
Program or another Sheppard Pratt outpatient clinic with medical documentation of TBI
or ABI

- Proficient in the English language

- Available to come to Sheppard Pratt Towson for the baseline evaluation and testing and
for the duration of the protocol

- Stable neurological and psychiatric symptomatology for 2 months prior to trial
initiation as determined by the referring Sheppard Pratt physician.

- Stable medication dose and regimen for 2 months

NCD Patients Inclusion Criteria

- Age 60-75

- NCD diagnosed by a Sheppard Pratt physician, per DSM-5

- No abnormalities on other serum tests to rule out other cause of cognitive impairment:
TSH, B12, CBC, Chemistry screen, and RPR.

- Recent structural neuroimaging (within 1 year or since the time of the onset of
cognitive complaint)-noncontrast head CT or MRI-to rule out any gross lesion
inconsistent with the diagnosis of MCI (e.g. subdural hematoma, normal pressure
hydrocephalus, demyelinating lesion, infarct, or mass lesion)

- Proficient in the English language

- A current or former patient at the clinics of the Sheppard Pratt Neuropsychiatry
Program or another Sheppard Pratt outpatient clinic with medical documentation of NCD

- Available to come to Sheppard Pratt Towson for the baseline evaluation and testing and
for the duration of the protocol

- Stable neurological and psychiatric symptomatology for 2 months prior to trial
initiation as determined by the impression of the referring Sheppard Pratt physician.

- Stable medication dose and regimen for 2 months

Exclusion Criteria for All Patients:

- History of, or active, liver disease or abnormal liver function tests--if the patient
currently has elevated Alanine Transaminase (ALT) or Aspartate Transaminase (AST)
levels that exceed 2 times the upper limit of normal [Normal Reference Ranges ALT
(Male: 4-40 IU/L, Female: 4-40 IU/L), AST (Male: 4-31 IU/L, Female: 4-37 IU/L) or the
ratio of AST:ALT has exceeded 2:1

- Active alcohol use disorder, as defined by DSM-5, of any severity mild, moderate, or
severe

- History of, or active, cardiovascular disease defined as: coronary heart disease,
manifested by myocardial infarction, angina pectoris, or heart failure

- Uncontrolled hypo-or hypertension based on Joint National Committee criteria (JNC7)
Hypotension: Systolic<90mmHg or diastolic<60mmHg Hypertension: Systolic >140mmHg or
diastolic>90 mmHg)

- History of extra-pyramidal symptoms (e.g. tardive dyskinesia, neuroleptic malignant
syndrome, or QT prolongation) while on a first-generation anti-psychotic

- Active illicit substance use, resulting in a substance use disorder as defined by
DSM-5, of any severity mild, moderate, or severe

- Patient is currently taking tolcapone or any of the following medications that can
interact with tolcapone resulting in an adverse events: another COMT inhibitor,
benserazide, α-methyldopa, dobutamine, apomorphine, isoproterenol, clozapine, MAO
inhibitor

- Known allergy or serious adverse reaction to tolcapone

- Participated in any investigational drug trial in the past 30 days.

- Pregnant or planning to become pregnant during the study period

- Breastfeeding or planning to breastfeed during the study period.

Other Exclusion Criteria for TBI Patients

• Presence of pre-morbid/pre-TBI cognitive impairment or behavioral dysfunction, as per
informant or medical documentation