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CompletedPhase 3

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

Asset

LMTM

Listed sites

67

Recruiting sites

-

Enrollment

220

actual

Study population

Frontotemporal dementia

Key I/E criteria

•MMSE ≥20•Study partner/caregiver required•MRI contraindications excluded

Primary endpoints

•Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R)•Change from Baseline on Functional Activities Questionnaire (FAQ)•Change from Baseline on whole brain volume

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

NCT IDNCT01626378
Org study IDTRx-237-007

Timeline

Milestones

Study first posted2012-06-22estimated
Study start2013-05 (month precision)
Primary completion2016-02actual (month precision)
Study completion2016-02actual (month precision)
Last update posted2018-03-14actual

Assets

Drug assets

LMTM

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Maximum age79 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable bvFTD
•Centrally rated frontotemporal atrophy score of 2 or greater on brain MRI
•MMSE ≥20
•Age <80 years
•Modified Hachinski ischemic score of ≤ 4
•Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
•Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent
•Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
•If currently taking an acetylcholinesterase inhibitor and/or memantine, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
•Able to comply with the study procedures

Exclusion criteria

•Significant central nervous system (CNS) disorder other than bvFTD
•Significant intracranial pathology seen on brain MRI scan
•Biomarker evidence of underlying Alzheimer's disease pathology
•Expressive language deficits
•Meets research criteria for Amyotrophic Lateral Sclerosis or motor neuron disease
•Meets diagnostic criteria for probable bvFTD but has a proven mutation producing non-tau, non-TDP-43 pathology
•Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
•Epilepsy
•Rapid eye movement sleep behavior disorder
•Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
•Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
•Resides in hospital or moderate to high dependency continuous care facility
•History of swallowing difficulties
•Pregnant or breastfeeding
•Glucose-6-phosphate dehydrogenase deficiency
•History of significant hematological abnormality or current acute or chronic clinically significant abnormality
•Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator
•Clinically significant cardiovascular disease or abnormal assessments
•Preexisting or current signs or symptoms of respiratory failure
•Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than bvFTD
•Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
•Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
•Treatment currently or within 90 days before Baseline with any of the following medications (unless otherwise noted):
-Tacrine
-Amphetamine or dexamphetamine
-Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
-Carbamazepine, primidone
-Drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses
•Current or prior participation in a clinical trial as follows:
-Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo)
-A clinical trial of a drug, biologic, device, or medical food in which the last dose/administration was received within 28 days prior to Baseline

Endpoints (12)

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

Global cognition
3
Other (unclassified)
3
Function / daily living
2
Neuroimaging
2
Behavior / neuropsychiatric
1
Other clinical outcomes
1

Global cognition

3 endpoints
Primary/protocol endpoint

Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R)

Time frame:52 weeks

change from baseline, improvement

Other/protocol endpoint

Change from Baseline on Mini-Mental Status Examination (MMSE)

Time frame:52 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other/protocol endpoint

Change from Baseline on Addenbrooke's Cognitive Examination-III (ACE-III)

Time frame:52 weeks

change from baseline, improvement

Function / daily living

2 endpoints
Primary/protocol endpoint

Change from Baseline on Functional Activities Questionnaire (FAQ)

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on Frontotemporal Dementia Rating Scale (FRS)

Time frame:52 weeks

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes

Time frame:52 weeks

event count, event

Neuroimaging

2 endpoints
Primary/protocol endpoint

Change from Baseline on whole brain volume (assessed by brain MRI)

Time frame:52 weeks

change from baseline, improvement

Other/protocol endpoint

Change from Baseline on the rate of atrophy in frontal and temporal lobes as well as ventricular volume (assessed by brain MRI)

Time frame:52 weeks

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change from Baseline on Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (modified ADCS-CGIC)

Time frame:52 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change from Baseline on Unified Parkinson's Disease Rating Scale (UPDRS Parts II and III)

Time frame:52 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Early effect on modified ADCS-CGIC (change from Baseline)

Time frame:8 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Determine the effect of TRx0237 in subjects with known genetic mutations associated with bvFTD

Time frame:52 weeks

descriptive

Publications (1)

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 tableno registry results posted yet

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.