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Catechol-O-Methyltransferase (COMT) Inhibitor
Tolcapone for Cognitive Dysfunction
Phase 2
Waitlist Available
Led By Robert J Schloesser, MD
Research Sponsored by Sheppard Pratt Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-70
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights
Study Summary
This trial is testing whether a drug called tolcapone can help improve symptoms in people with BI or NCD. The trial will last for two weeks, and researchers will be looking to see which areas of patients' lives are affected by tolcapone treatment.
Who is the study for?
This trial is for adults aged 18-75 with a history of brain injury (TBI or ABI) or neurocognitive disorder (NCD), stable in health and medication for at least 2 months. Participants must not have severe cardiovascular, liver disease, substance abuse issues, or known allergies to tolcapone.Check my eligibility
What is being tested?
The study tests the effects of Tolcapone on cognitive and behavioral functions in patients with brain injuries and NCD over two weeks. It's an open-label trial aiming to identify who benefits from the treatment.See study design
What are the potential side effects?
Potential side effects of Tolcapone may include liver problems, diarrhea, sleep disturbances, fatigue, increased sweating, headache, dizziness. Serious reactions are rare but can involve muscle control disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
I've had a brain scan in the last year to check for major brain issues unrelated to my memory problems.
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I am between 60 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Clinical Global Impression Scale (CGI) to two weeks after medication administration
Secondary outcome measures
Change from Baseline NIH Toolbox Cognition Battery to two weeks after medication administration
Change from Baseline TBI-QoL to two weeks after medication administration
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-LabelExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolcapone
FDA approved
Find a Location
Who is running the clinical trial?
Sheppard Pratt Health SystemLead Sponsor
21 Previous Clinical Trials
7,709 Total Patients Enrolled
Lieber Institute for Brain Development (LIBD)UNKNOWN
Robert J Schloesser, MDPrincipal InvestigatorSheppard Pratt Health System
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is not well controlled and falls outside the normal range.I am not taking tolcapone or any medication that interacts with it.You have had a bad reaction to tolcapone in the past.You had memory or behavior problems before the head injury.I am between 18 and 70 years old.My mental health has been stable for the last 2 months.You currently use illegal drugs and have a problem with addiction.You have a current problem with drinking too much alcohol, as determined by specific guidelines.I have been diagnosed with a traumatic brain injury or have a history of brain injury.My head injury happened more than a year ago.You have been a patient at the Sheppard Pratt Neuropsychiatry Program or another Sheppard Pratt outpatient clinic with medical documentation of traumatic brain injury or acquired brain injury.You have been diagnosed with a specific mental health condition by a doctor at Sheppard Pratt using a specific diagnostic manual.I've had a brain scan in the last year to check for major brain issues unrelated to my memory problems.I have a history of heart disease, such as heart attack, chest pain, or heart failure.My liver function tests are within normal limits or not more than twice the upper limit.I've had movement or severe muscle issues with old antipsychotic meds.My mental health has been stable for the last 2 months.You are currently or used to be a patient at Sheppard Pratt Neuropsychiatry Program or another Sheppard Pratt outpatient clinic and have medical records showing a neurocognitive disorder.Your blood tests for thyroid, vitamin B12, blood cell count, and general health should be normal.I am between 60 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I be a candidate for this research project?
"Those with kandinsky syndrome who are looking to participate in this study should be between 18-75 years old. Out of the 100 planned enrollees, how many will you hope to recruit?"
Answered by AI
What is the federal government's opinion on Tolcapone?
"Tolcapone received a score of 2 because, while there is some evidence suggesting it is safe, none of the clinical data points to it being an effective treatment."
Answered by AI
Is it possible to sign up for this experiment?
"According to the latest information from clinicaltrials.gov, this study is not recruiting patients at the moment. The trial was first posted on November 1st, 2015 and updated January 17th, 2017. Although this particular study isn't looking for participants, there are 983 other studies that are actively recruiting right now."
Answered by AI
Will this research include any elderly participants?
"The age requirement for this clinical trial is 18-75. There are 773 trials for patients over 65 and 164 for those under the age of 18."
Answered by AI
How many people are sign up to participate in this clinical trial?
"Presently, this study is not looking for any more participants as it has already completed its clinical trial. However, if you are searching for other trials, there are currently 979 trials actively recruiting patients with kandinsky syndrome and 4 Tolcapone trials also seeking participants."
Answered by AI
What is the historical success rate of Tolcapone in clinical trials?
"At present, there are 4 active Tolcapone trials with 0 in Phase 3. Most of the research for Tolcapone is conducted in Somerville, New jersey; however, there are four total locations running these clinical trials."
Answered by AI
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