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CompletedPhase 2Results posted

Effects of Tolcapone on Frontotemporal Dementia

Investigation of the Dopamine System in Frontotemporal Dementia

Lead sponsor

Columbia University

Asset

Tolcapone

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Symptomatic FTD

Primary endpoints

•Reaction Time on the N-back Cognitive Test (0-back Condition)•Reaction Time on the N-back Cognitive Test (1-back Condition)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih5R00NS060766

Org study IDAAAF4151

NCT IDNCT00604591

Timeline

Milestones

Study first posted2008-01-30estimated

Study start2008-01-30actual

Primary completion2016-06-16actual

Study completion2016-06-16actual

Last update posted2024-08-28actual

Results first posted2024-08-28actual

Assets

Drug assets

Tolcapone

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of frontotemporal dementia (FTD)

•Age 40 to 85

•Assigned durable power of attorney

•Caregiver willing and able to accept the responsibilities involved in the study

•Mattis Dementia Rating Scale-2 (MDRS2) score less than 132

Exclusion criteria

•The diagnosis of any other type of dementia besides FTD including Alzheimer's disease, Lewy body dementia, vascular dementia, dementia associated with Parkinson's disease, corticobasal syndrome, and progressive supranuclear palsy.

•Known allergy or serious adverse reaction to tolcapone

•Active liver disease

•Current alcohol abuse

•Active substance abuse

•Elevated liver function tests

•Patient is taking tolcapone or any other catechol-O-methyltransferase (COMT) inhibitor, benserazide, alpha-methyldopa, dobutamine, apomorphine, isoproterenol, an monoamine oxidase inhibitor (MAO-I), or clozapine

•Symptomatic cardiovascular disease (e.g., angina, transient ischemic attack (TIA) , syncope)

•Uncontrolled hyper- or hypotension

•Any other contraindication to tolcapone

•Any medication that significantly affects the dopamine system, including stimulants and antipsychotic medications

•Pregnant women

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Global cognition

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Score on the Repeated Battery for the Assessment of Neurological Status (RBANS) for Dementia

Time frame:First intervention: Day 8 and Second intervention: Day 21

categorical status, descriptive

Secondary/registry result

Score on the Repeated Battery for the Assessment of Neurological Status (RBANS) for Dementia

Time frame:First intervention: Day 8 and Second intervention: Day 21

categorical status, descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=28 Participants	67.89	17.66
Tolcaponen=28 Participants	66.57	18.32

Memory

4 endpoints

Primary/protocol endpoint

Reaction Time on the N-back Cognitive Test (0-back Condition)

Time frame:First intervention: Day 8 and Second intervention: Day 21

descriptive

Primary/protocol endpoint

Reaction Time on the N-back Cognitive Test (1-back Condition)

Time frame:First intervention: Day 8 and Second intervention: Day 21

descriptive

Primary/registry result

Reaction Time on the N-back Cognitive Test (0-back Condition)

Time frame:First intervention: Day 8 and Second intervention: Day 21

descriptive

Posted result

Group	Value (mean), milliseconds	Standard deviation
Placebon=28 Participants	7935	2563
Tolcaponen=28 Participants	8322	1940

Primary/registry result

Reaction Time on the N-back Cognitive Test (1-back Condition)

Time frame:First intervention: Day 8 and Second intervention: Day 21

descriptive

Posted result

Group	Value (mean), milliseconds	Standard deviation
Placebon=28 Participants	7060	2475
Tolcaponen=28 Participants	8226	2842

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Score on Neuropsychiatric Inventory Questionnaire (NPI-Q)

Time frame:First intervention: Day 8 and Second intervention: Day 21

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/registry result

Score on Neuropsychiatric Inventory Questionnaire (NPI-Q)

Time frame:First intervention: Day 8 and Second intervention: Day 21

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=28 Participants	8.68	4.83
Tolcaponen=28 Participants	8.21	4.50

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Score on the Clinical Global Impressions (CGI) Scale

Time frame:First intervention: Day 8 and Second intervention: Day 21

descriptive

Secondary/registry result/low confidence

Score on the Clinical Global Impressions (CGI) Scale

Time frame:First intervention: Day 8 and Second intervention: Day 21

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=28 Participants	4.14	0.76
Tolcaponen=28 Participants	3.75	0.65

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.