TerminatedPhase 2Results posted

Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease

A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy

Lead sponsor

TauRx Therapeutics Ltd

Asset

LMTM

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 14-26•Study partner/caregiver required

Primary endpoint

•Safety and Tolerability of TRx0237 When Coadministered With

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 IDNCT01626391

Org study IDTRx-237-008

Timeline

Milestones

Study first posted2012-06-22estimated

Study start2012-09 (month precision)

Primary completion2013-03actual (month precision)

Study completion2013-03actual (month precision)

Last update posted2014-07-11estimated

Results first posted2014-07-11estimated

Assets

Drug assets

LMTM

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of all cause dementia and probable Alzheimer's disease (AD)

•Mini-Mental State Examination (MMSE) score of 14-26 (inclusive)

•Cognitive impairment present for at least 6 months

•Age ≤90 years

•Modified Hachinski ischaemic score of ≤4

•Females, if of childbearing potential, must use adequate contraception and maintain this use throughout participation in the study

•Patient is able to read, understand, and provide written informed consent

•Has one or more identified caregivers who are able to verify daily compliance with study drug and provide information on safety and tolerability; the caregiver(s) must also give consent to participate

•Currently taking an 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 disorder other than Alzheimer's disease

•Patients in whom baseline MRI is contraindicated such as metal implants in head (except dental), pacemaker, and cochlear implant

•Significant focal or intracranial pathology that would lead to a diagnosis other than probable Alzheimer's disease

•Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness

•Epilepsy

•Major depressive disorder, schizophrenia or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders

•Resides in a hospital or continuous care facility

•History of swallowing difficulties

•Pregnant or breastfeeding

•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

•Pre-existing or current signs or symptoms of respiratory failure

•Concurrent acute or chronic clinically significant immunologic, renal, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease

•Prior intolerance to methylthioninium-containing drug or any of the excipients

•Treatment currently or within 3 months before Baseline with any of the following medications (unless otherwise noted):

-Tacrine

-Anxiolytics and/or sedatives/hypnotics (exceptions: sedation for MRI or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime)

-Antipsychotics (clozapine, chlorpromazine, thioridazine, or ziprasidone)

-Carbamazepine

-Drugs associated with methaemoglobinaemia (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine and related antimalarials, sulfonamides)

-Warfarin (and other Coumadin derivates such as phenprocoumon)

•Current or prior participation in a clinical trial of a drug, biologic, or device in which the last dose was received within 28 days prior to Baseline

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

Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine

Time frame:8 weeks

event count, event

Primary/registry result

Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine

Time frame:8 weeks

event count, event

Posted result

Group	Value (number), participants	Reported bounds
TRx0237n=5 Participants	4	-
Placebon=4 Participants	4	-

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.