Trial · NCT00604591
Effects of Tolcapone on Frontotemporal Dementia
NCT00604591, Phase 2, Completed, Columbia University; results first posted 2024-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Tolcapone on Frontotemporal Dementia. Trials, record NCT00604591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00604591
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Tolcapone on Frontotemporal Dementia
- NCT number
- NCT00604591
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Frontotemporal Lobar Degeneration
- Interventions
- Tolcapone, Placebo
- First posted
- 2008-01-30
- Last updated
- 2024-08-28
- Results first posted
- 2024-08-28
- Limitations and caveats
A modified and simplified version of the N-back task was used because patients with FTD were incapable of performing the original version. Another limitation was the relatively brief duration of treatment conditions and washout.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reaction Time on the N-back Cognitive Test (0-back Condition) | First intervention: Day 8 and Second intervention: Day 21 | 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 button with the number on the screen. Three blocks of 40 images will be administered during the working memory task for a total of 120 images. |
| Primary | Reaction Time on the N-back Cognitive Test (1-back Condition) | First intervention: Day 8 and Second intervention: Day 21 | 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 1-back condition, the subjects are instructed to report the number presented one number back from the number displayed on the screen. Three blocks of 40 images will be administered during the working memory task for a total of 120 images. |
| Secondary | Score on Neuropsychiatric Inventory Questionnaire (NPI-Q) | First intervention: Day 8 and Second intervention: Day 21 | The NPI-Q is a retrospective caregiver/informant-based interview that assesses 12 neuropsychiatric symptom domains including delusions, hallucinations, agitation/aggression, depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, night-time behavioral disturbances and appetite/eating disturbances. Each symptom within a domain are rated by the caregiver in terms of severity (1=mild to 3=severe). Total scores are calculated by adding the composite scores to obtain a score ranging from 0 (no symptoms, better outcome) to 36. |
| Secondary | Score on the Repeated Battery for the Assessment of Neurological Status (RBANS) for Dementia | First intervention: Day 8 and Second intervention: Day 21 | The RBANS is a brief, individually administered test that captures multiple cognitive domains, including attention, language, visuospatial/constructional abilities, immediate memory, and delayed memory. Index scores range from 0 to 20 (better outcome) for each of the 5 domains tested and the composite scores are added to generated a total index score, which ranges from 0 to 100 (better outcome). |
| Secondary | Score on the Clinical Global Impressions (CGI) Scale | First intervention: Day 8 and Second intervention: Day 21 | The CGI is often used in treatment studies as a proxy for global functioning and is a subjective score assigned by the treating physician that incorporates elements of illness severity, patient distress, patient impairment, and functioning. The CGI is given a numerical ranking each visit after the first, with 6=major worsening, 5=mild worsening, 4=no change, 3=mild improvement, and 2=major improvement. Scores range from a 2 (better outcome) to a 6 (worse outcome). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reaction Time on the N-back Cognitive Test (0-back Condition) | First intervention: Day 8 and Second intervention: Day 21 | milliseconds | MEAN | |
| PRIMARY | Reaction Time on the N-back Cognitive Test (1-back Condition) | First intervention: Day 8 and Second intervention: Day 21 | milliseconds | MEAN | |
| SECONDARY | Score on Neuropsychiatric Inventory Questionnaire (NPI-Q) | First intervention: Day 8 and Second intervention: Day 21 | score on a scale | MEAN | |
| SECONDARY | Score on the Repeated Battery for the Assessment of Neurological Status (RBANS) for Dementia | First intervention: Day 8 and Second intervention: Day 21 | score on a scale | MEAN | |
| SECONDARY | Score on the Clinical Global Impressions (CGI) Scale | First intervention: Day 8 and Second intervention: Day 21 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reaction Time on the N-back Cognitive Test (0-back Condition) | Placebo | 7935 | Standard Deviation 2563 | milliseconds | |
| Reaction Time on the N-back Cognitive Test (0-back Condition) | Tolcapone | 8322 | Standard Deviation 1940 | milliseconds | |
| Reaction Time on the N-back Cognitive Test (1-back Condition) | Placebo | 7060 | Standard Deviation 2475 | milliseconds | |
| Reaction Time on the N-back Cognitive Test (1-back Condition) | Tolcapone | 8226 | Standard Deviation 2842 | milliseconds | |
| Score on Neuropsychiatric Inventory Questionnaire (NPI-Q) | Placebo | 8.68 | Standard Deviation 4.83 | score on a scale | |
| Score on Neuropsychiatric Inventory Questionnaire (NPI-Q) | Tolcapone | 8.21 | Standard Deviation 4.50 | score on a scale | |
| Score on the Repeated Battery for the Assessment of Neurological Status (RBANS) for Dementia | Placebo | 67.89 | Standard Deviation 17.66 | score on a scale | |
| Score on the Repeated Battery for the Assessment of Neurological Status (RBANS) for Dementia | Tolcapone | 66.57 | Standard Deviation 18.32 | score on a scale | |
| Score on the Clinical Global Impressions (CGI) Scale | Placebo | 4.14 | Standard Deviation 0.76 | score on a scale | |
| Score on the Clinical Global Impressions (CGI) Scale | Tolcapone | 3.75 | Standard Deviation 0.65 | score on a scale |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (Day 1 to Day 8) | STARTED | Placebo Then Tolcapone | 14 | |
| First Intervention (Day 1 to Day 8) | STARTED | Tolcapone Then Placebo | 14 | |
| First Intervention (Day 1 to Day 8) | COMPLETED | Placebo Then Tolcapone | 14 | |
| First Intervention (Day 1 to Day 8) | COMPLETED | Tolcapone Then Placebo | 14 | |
| First Intervention (Day 1 to Day 8) | NOT COMPLETED | Placebo Then Tolcapone | 0 | |
| First Intervention (Day 1 to Day 8) | NOT COMPLETED | Tolcapone Then Placebo | 0 | |
| Washout (Day 9 to Day 14) | STARTED | Placebo Then Tolcapone | 14 | |
| Washout (Day 9 to Day 14) | STARTED | Tolcapone Then Placebo | 14 | |
| Washout (Day 9 to Day 14) | COMPLETED | Placebo Then Tolcapone | 14 | |
| Washout (Day 9 to Day 14) | COMPLETED | Tolcapone Then Placebo | 14 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Elevated liver enzymes | Hepatobiliary disorders | All Participants | 6 | 28 | 6 |
| other | Nausea | General disorders | All Participants | 4 | 28 | 4 |
| other | Diarrhea | Gastrointestinal disorders | All Participants | 4 | 28 | 4 |
| other | Headache | General disorders | All Participants | 4 | 28 | 4 |
| other | Constipation | Gastrointestinal disorders | All Participants | 3 | 28 | 3 |
| other | Upset Stomach | Gastrointestinal disorders | All Participants | 2 | 28 | 2 |
| other | Hyperactive Bowel Syndrome | Gastrointestinal disorders | All Participants | 2 | 28 | 2 |
| other | Moderate fall | Injury, poisoning and procedural complications | All Participants | 2 | 28 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 28 |
| Total, other adverse events | All Participants | 6 | 28 |
| Total, serious adverse events | All Participants | 0 | 28 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R00NS060766 | Investigation of the dopamine system in frontotemporal dementia | HUEY, EDWARD D | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2009 to 2011 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| 2-Back Task | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00604591
GET https://conductscience.org/api/trials/v1/NCT00604591/registered