Cure My Disease

Don't miss your cure!

 Log in / Sign up

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

NCT ID NCT03446001

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Alzheimer disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.