Alzheimer's drug TRx0237 put to the test in large trial

NCT ID NCT03446001

Disease control Sponsor: TauRx Therapeutics Ltd Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a drug called TRx0237 can help people with Alzheimer's disease. About 600 participants took either a low dose, a higher dose, or a placebo for 12 months, followed by a year where everyone could get the drug. The goal was to see if the drug slows memory loss and helps with daily activities. The trial is complete, and results will show if TRx0237 is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TRx0237 (a drug taken orally as tablets)
What this could lead to: If successful, this could lead to a treatment that slows or modifies the course of Alzheimer's disease, potentially helping patients maintain cognitive function and daily living skills longer.
What could go wrong: This is a Phase 3 trial, but previous similar drugs have failed. The results may show no benefit over placebo, and side effects could occur. The study is completed, so results are pending analysis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

598 people

The number who actually took part.

Started

Dec 2017

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Alzheimer's Disease (AD), encompassing probable AD and mild cognitive impairment due to AD (MCI-AD) based on the 2011 National Institute on Aging and Alzheimer's Association (NIA/AA) criteria * Documented PET scan that is positive for amyloid * Mini-Mental State Examination (MMSE) score of 16-27 (inclusive), subject to stratification requirements * Global Clinical Dementia Rating (CDR) of 0.5 to 2 (if 0.5, including a score of \>0 in one of the functional domains: Community Affairs, Home and Hobbies, or Personal Care) * Age \<90 years * Females must be surgically sterile, have undergone bilateral tubal occlusion / ligation, be post-menopausal, or use adequate contraception * Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with local and national law is/are able to read, understand, and provide written informed consent in the designated language of the study site * Has one or more identified adult study partner who either lives with the subject or has sufficient contact to provide assessment of changes in subject behavior and function over time and information on safety and tolerability; is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language(s) at the study site; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug * Must not be taking an acetylcholinesterase inhibitor and/or memantine for at least 60 days at the time of the Baseline assessments * Able to comply with the study procedures in the view of the Investigator Exclusion Criteria: * Significant central nervous system disorder other than probable AD or MCI-AD * Significant intracranial focal or vascular pathology seen on brain MRI scan that would lead to a diagnosis other than probable AD or MCI-AD * Clinical evidence or history of cerebrovascular accident; transient ischemic attack; significant head injury, for example, associated loss of consciousness, skull fracture or persisting cognitive impairment; other unexplained or recurrent loss of consciousness for ≥15 minutes * Epilepsy (a single prior seizure \>6 months prior to Screening is considered acceptable) * Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria met for major depressive disorder; schizophrenia; other psychotic disorders, bipolar disorder; substance (including alcohol) related disorders * Metal implants in the head, 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 * Any physical disability that would prevent completion of study procedures or assessments * History of swallowing difficulties * Pregnant or breastfeeding * Glucose-6-phosphate dehydrogenase (G6PD) 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 significant by the Investigator * Clinically significant cardiovascular disease or abnormal electrocardiogram assessments * Pre-existing or current signs or symptoms of respiratory failure * Concurrent acute or chronic clinically significant immunologic, hepatobiliary, or endocrine disease and/or other unstable or major disease other than probable AD or MCI-AD * Diagnosis of cancer (excluding basal cell carcinoma, squamous cell carcinoma, or prostate carcinoma in situ \[Stage 1\]) within the past 2 years or a previous (\>2 years) diagnosis of cancer that has required any form of intervention or treatment within the past 2 years * Prior intolerance or hypersensitivity to methylthioninium (MT)-containing drug or methemoglobinemia induced by MT-containing drug, similar organic dyes, or any of the excipients * Treatment currently or within 90 days before Baseline with Souvenaid®, clozapine, carbamazepine, primidone, valproate, or drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses * Current or prior participation in any clinical trial of TRx0237; a clinical trial of a product for cognition prior to Baseline in which the last dose was received within 90 days prior to Baseline unless confirmed to have been randomized to placebo; or a clinical trial of any other investigational drug, biologic, device, or medical food in which the last dose was received within 28 days prior to Baseline

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States
Advance Medical Research Center

Miami, Florida, 33135, United States
Advanced Memory Research of NJ PC

Toms River, New Jersey, 08755, United States
Albany Medical College

Albany, New York, 12208, United States
Allied Biomedical Research Institute

Miami, Florida, 33155, United States
Alpha Recherche Clinique

Québec, G3K 2P8, Canada
Alzheimer's Memory Center

Charlotte, North Carolina, 28270, United States
Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States
Arizona Research Center

Phoenix, Arizona, 85053, United States
Atria Clinical Research

Little Rock, Arkansas, 72209, United States
Azienda Ospedaliera San Gerardo - Clinica Neurologica

Monza, 20900, Italy
Azienda Ospedaliera Sant'Andrea

Roma, 00189, Italy
Bioclinica Research

Orlando, Florida, 32806, United States
Biomed Research Institute, Inc

Miami, Florida, 33126, United States
CBRI - Roper Hospital

Charleston, South Carolina, 29414, United States
CCM Clinical Research Group

Miami, Florida, 33133, United States
CHU Bordeaux - Pellegrin

Bordeaux, 33076, France
CHU de Limoges

Limoges, 87042, France
CHU de Rennes

Rennes, 35009, France
CRC Gerontopole Cite de la Sante, Hôpital La Grave

Toulouse, 31059, France
California Neuroscience Medical Group

Sherman Oaks, California, 91403, United States
Centro de salud de San Juan, Unidad de Investigación Neurociencias

Salamanca, 37005, Spain
Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland
Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland
Clinica Neurologica Santa Maria della Misericordia

Udine, 33100, Italy
Clinique Mémoire de l'Outaouais

Gatineau, Quebec, J8T 8J1, Canada
Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium
Coastal Neurology

Port Royal, South Carolina, 29935, United States
Emerald Coast Center for Neurological Disorders

Pensacola, Florida, 32504, United States
Euromedis Sp. z o.o.

Szczecin, 70-111, Poland
Excell Research, Inc.

Oceanside, California, 92056, United States
Finlay Medical Research

Greenacres City, Florida, 33467, United States
Finlay Medical Research

Miami, Florida, 33126, United States
Florida International Research Center

Miami, Florida, 33173, United States
Foundation Institute G.Giglio

Cefalù, 90015, Italy
Fullerton Neurology and Headache Center

Fullerton, California, 92835, United States
Future Care Solution, LLC

Miami, Florida, 33165, United States
Georgia Neurology and Sleep Medicine Associates

Suwanee, Georgia, 30024, United States
Glasgow Memory Clinic Ltd

Glasgow, G20 0XA, United Kingdom
Guidechauliac Hospital

Montpellier, 34295, France
HB Clinical Trials Inc.

Fountain Valley, California, 92708, United States
Health Care Family Rehab and Research

Miami, Florida, 33015, United States
Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States
Hopital des Charpennes

Villeurbanne, 69100, France
Hospital General de Catalunya

Barcelona, 08195, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Doctor Peset

Valencia, 46017, Spain
Hospital Universitario Mutua Terrassa

Terrassa, 08222, Spain
Hospital Universitario QuironSalud Madrid

Madrid, 28223, Spain
Hospital Virgen de la Macarena

Seville, 41009, Spain
Hospitales de Madrid

Madrid, 28015, Spain
Hôpital Laënnec - CHU de Nantes

Nantes, 44093, France
Hôpital Neurologique Pierre Wertheimer

Bron, 69677, France
IMIC Inc

Palmetto Bay, Florida, 33157, United States
IPS Research Company

Oklahoma City, Oklahoma, 73106, United States
IRCCS Centro S. Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy
IRCCS Fondazione Santa Lucia

Rome, 00179, Italy
Imaging Endpoints Research

Scottsdale, Arizona, 85258, United States
Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States
Indywidualna Praktyka Lekarska

Lublin, 20-582, Poland
Istituto Neurologico Casimiro Mondino, IRCCS

Pavia, 27100, Italy
Josephson Wallack Munshower Neurology P.C.

Indianapolis, Indiana, 46256, United States
Kingfisher Cooperative, LLC

Spokane, Washington, 99202, United States
L&C Professional Medical Research Institute

Miami, Florida, 33144, United States
MD Clinical

Hallandale, Florida, 33009, United States
Memory Clinic (Ottawa)

Ottawa, Ontario, K1Z 1G3, Canada
Merrit Island Medical Research

Merritt Island, Florida, 32952, United States
Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States
NZOZ Neuro-Kard

Poznan, 61-853, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, 40-123, Poland
Neural Net Research

Portland, Oregon, 97225, United States
Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, 44321, United States
NeuroStudies.net, LLC

Decatur, Georgia, 30033, United States
Neurology Diagnostics Inc.

Dayton, Ohio, 45459, United States
Neuroscience Research Center, LLC

Canton, Ohio, 44718, United States
Okanagan Clinical Trials, Ltd.

Kelowna, British Columbia, V1Y 1Z9, Canada
Optimus Clinical Research

Miami, Florida, 33125, United States
Ospedale San Giovanni Calibita Fatebenefratelli

Roma, 00186, Italy
Podlaskie Centrum Psychogeriatrii

Bialystok, 15-756, Poland
Progressive Medical Research

Port Orange, Florida, 32127, United States
Re:Cognition Health

Fairfax, Virginia, 22031, United States
Re:Cognition Health

Birmingham, B16 8LT, United Kingdom
Re:Cognition Health

Guildford, GU2 7YD, United Kingdom
Re:Cognition Health

Plymouth, PL6 8BT, United Kingdom
Re:Cognition Health - Central London

London, W1G 9JF, United Kingdom
Richmond Behavioral Associates

Staten Island, New York, 10312, United States
Senior Clinical Trials, Inc.

Laguna Hills, California, 92653, United States
Sensible Healthcare

Ocoee, Florida, 34761, United States
Sharp Mesa Vista Hospital

San Diego, California, 92123, United States
Stedman Clinical Trials

Tampa, Florida, 33613, United States
Syrentis Clinical Research

Santa Ana, California, 92705, United States
The Lindner Research Center

Cincinnati, Ohio, 45219, United States
The Roskamp Institute, Inc.

Sarasota, Florida, 34243, United States
Timone Adults Hospital

Marseille, 13385, France
Tulsa Clinical Research LLC

Tulsa, Oklahoma, 74136, United States
UBMD Neurology

Buffalo, New York, 14203, United States
Universal Research Group, LLC

Tacoma, Washington, 98405, United States
University of Perugia, Ospedale S.M. della Misericordia

Perugia, 06156, Italy
Valley Medical Research

Centerville, Ohio, 45459, United States
Visionary Investigators Network

Aventura, Florida, 33180, United States
Visionary Investigators Network

Miami, Florida, 33176, United States
Vitae Research Center, LLC

Miami, Florida, 33135, United States
Xenoscience

Phoenix, Arizona, 85004, United States

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