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Completed Phase 2 Interventional Results available

Effects of Tolcapone on Frontotemporal Dementia

ClinicalTrials.gov ID: NCT00604591

Public ClinicalTrials.gov record NCT00604591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 3:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Investigation of the Dopamine System in Frontotemporal Dementia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will test the effects of a medication called tolcapone on cognitive, behavioral, and language problems seen in patients with frontotemporal dementia (FTD). Tolcapone increases the amount of dopamine, a brain chemical that may be lowered in FTD. The study will see if tolcapone can improve thinking, behavior, and language in people with FTD and will look at the effects of the drug on brain activity. Patients with FTD who are between 40 and 85 years of age may be eligible for this study. Participants will be seen as outpatients at the Columbia University Medical Center approximately one a week for 4 weeks. They take tolcapone or a placebo (a look-alike pill with no active ingredient) during study week 1. During study week 3, those who took placebo during week 1 now take tolcapone for 1 week and those who took tolcapone now take placebo. In addition, patients undergo the following tests and procedures: * Neurological tests to evaluate attention, problem-solving and memory. These tests are repeated several times during the course of the study. * Test to look for a gene that affects the amount of dopamine in the brain, using blood samples collected in a previous study. * Blood draws four times during the study. * Functional MRI (fMRI) to learn about changes in brain regions that are involved in performing tasks. For fMRI, the patient lies on a table that can slide in and out of the scanner, a narrow metal cylinder surrounded by a magnetic field. The procedure takes about 60 minutes and is performed four times over the course of the . FMRI involves taking pictures of the brain during MRI while the subject performs a task so that changes in the brain that occur during these tasks can be studied.

Study identification

NCT ID
NCT00604591
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Columbia University
Other
Enrollment
28 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 29, 2008
Primary completion
Jun 15, 2016
Completion
Jun 15, 2016
Last update posted
Aug 27, 2024

2008 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Columbia University Irving Medical Center New York New York 10032

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00604591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2024 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00604591 live on ClinicalTrials.gov.

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