Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT04205994
Eligibility Criteria:
Inclusion criteria:
* Ages 18-40 and right-handed
* Able to provide written informed consent
* Normal or corrected-to-normal visual acuity
* General good health as determined for tolcapone studies by screening provider (Dr. Kayser, Dr.Jagust, or other approved, licensed clinician)
Exclusion criteria:
* Regular and/or scheduled use of other neuro- or psycho-active medications
* Severe low blood pressure or uncontrolled high blood pressure
* Intelligence quotient (IQ) \< 70 as assessed by the Wechsler Test of Adult Reading (WTAR)
* History of mild, moderate, or severe traumatic brain injury
* History of brain surgery (i.e. violating brain parenchyma) or penetrating brain injury
* Active alcohol dependence or alcohol abuse by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (within previous 30 days)
* Active substance dependence or substance abuse by DSM-IV-TR criteria (excluding nicotine, but including marijuana, opiates, stimulants (cocaine, amphetamines), and hallucinogens within previous 30 days)
* History of suicide attempt (last 5 years)
* Clinically severe medical illness requiring treatment
* History of brain tumor, stroke, demyelinating disease, encephalitis, or cerebral aneurysm rupture
* Clinical diagnosis of Alzheimer's disease or other primary neurodegenerative disorder
* Schizophrenia or other psychiatric disturbances
For Subjects Undergoing fMRI Scanning:
* Contraindications to MRI (e.g. unremovable ferromagnetic metals, claustrophobia)
* Inability to complete basic fMRI requirements (e.g. to make button presses and to minimize movement \< 5mm)
* Women of childbearing potential take a urine pregnancy test prior to scanning.
For Tolcapone Experiments:
* Contraindications to tolcapone use, including liver function tests elevated more than 2.5 times above normal ranges, pregnancy, previous adverse reaction to tolcapone, significant liver or kidney impairment
* Current use (within previous 30 days) of pharmacological agents with dopaminergic actions, including but not limited to levodopa/carbidopa, entacapone, tolcapone, amantadine, bromocriptine, pergolide, pramipexole, ropinirole, selegiline, isocarboxazid, phenelzine, tranylcypromine, clozapine, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, fluphenazine, haloperidol, perphenazine, pimozide, thiothixene, trifluoperazine, loxapine, molindone, chlorpromazine, mesoridazine, thioridazine, promethazine, dextroamphetamine, dexmethylphenidate, dextroamphetamine, or methylphenidate
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04205994
Study Brief:
Protocol Section:
NCT04205994