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

This is an interventional treatment trial for Brain Injuries, Traumatic Read More

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