TerminatedPhase 3Results posted

Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

Lead sponsor

TauRx Therapeutics Ltd

Asset

LMTM

Listed sites

135

Recruiting sites

Enrollment

913

actual

Study population

Alzheimer’s disease, Frontotemporal dementia

Key I/E criteria

•Multiple dementia etiologies•Study partner/caregiver required

Primary endpoint

•Serious or Non-serious Adverse Events

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 IDNCT02245568

Org study IDTRx-237-020

Timeline

Milestones

Study start2014-08actual (month precision)

Study first posted2014-09-19estimated

Primary completion2017-05actual (month precision)

Study completion2017-05actual (month precision)

Results first posted2020-06-02actual

Last update posted2023-05-24actual

Assets

Drug assets

LMTM

Study populations

Who this study enrolls

Alzheimer’s diseaseFrontotemporal dementia

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects with all cause dementia and probable Alzheimer's disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.

•Subjects with a diagnosis of probable bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).

•Females, if of child-bearing potential, must practice true abstinence or continue 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 and ethics approval is/are able to read, understand, and provide written informed consent

•Has an 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 ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug

•Able to comply with the study procedures

Exclusion criteria

•History of swallowing difficulties

•Pregnant or breastfeeding

•Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit

•Current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food

•In Germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants With Serious or Non-serious Adverse Events

Time frame:Up to 34 months

event count, event

Primary/registry result

Number of Participants With Serious or Non-serious Adverse Events

Time frame:Up to 34 months

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
LMTM 100-300 mg/Dayn=896 Participants	734	-

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.