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NCT00604591 · ClinicalTrials.gov registry record · Phase 2
Effects of Tolcapone on Frontotemporal Dementia
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00604591: Completed Phase 2 study, sponsored by Columbia University.
NCT00604591 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00604591, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
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.
Primary Outcome
In the N-back task, subjects are given a response pad with response buttons numbered 1, 2, 3, and 4 at the points of a diamond-shaped box and shown a random series of numbers from 1 to 4 appearing for 500 ms every 1.8 seconds at locations corresponding to the positions of the numbers on the response pad. Instructions presented on the screen above the diamond instruct patients to recall the stimulus seen "N" numbers previously. In the 0-back condition, the subjects are instructed to press the but
Interventions
- DRUG Placebo
- DRUG Tolcapone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-01-30 |
| Est. Completion | 2016-06-16 |
| Phase | Phase 2 |
What the finished NCT00604591 record still lists
NCT00604591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00604591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00604591 about?
NCT00604591 is a clinical study titled "Effects of Tolcapone on Frontotemporal Dementia". 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 ...
What is the current status of trial NCT00604591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2008-01-30. Estimated completion is 2016-06-16.
What interventions are being tested in trial NCT00604591?
The interventions under investigation include: Placebo (DRUG), Tolcapone (DRUG).
Who is sponsoring clinical trial NCT00604591?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00604591's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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