Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment

NCT03446001 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: TRx-237-039
• Study Type: interventional
• Target: 598
• Locations: 8 countries
• Sites: 103

Brief Summary

The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (16 mg/Day vs Control)

  This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).

  52 weeks

• Change From Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (16 mg/Day vs Control)

  This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 78, with higher numbers indicating a better outcome (lower impairment).

  52 weeks

• Number of Study Participants With Serious and Non-serious Adverse Events (16 mg/Day vs Control)

  This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the placebo group. All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator are to be reported as adverse events.

  52 weeks

Secondary Outcomes (10)

• Change in Annualized Rate of Whole Brain Atrophy (16 mg/Day vs Control)

  52 weeks

• Change in Standardized Uptake Value Ratio (SUVR) Based on Temporal Lobe 18F-fluorodeoxyglucose Positron Emission Tomography (18F-FDG-PET) (16 mg/Day vs Control)

  52 weeks

• Change in Annualized Rate of Temporoparietal Lobe Atrophy (16 mg/Day vs Control)

  52 weeks

• Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (8 mg/Day vs Control)

  52 weeks

• Change From Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (8 mg/Day vs Control)

  52 weeks

Study Arms (3)

TRx0237 16 mg/day

EXPERIMENTAL

Drug: TRx0237 16 mg/day

Control

PLACEBO COMPARATOR

Drug: Control

TRx0237 8 mg/day

EXPERIMENTAL

Drug: TRx0237 8 mg/day

Interventions

TRx0237 16 mg/day DRUG

Oral TRx0237 4-mg tablets administered twice daily

TRx0237 16 mg/day

Control DRUG

Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily

Control

TRx0237 8 mg/day DRUG

Oral TRx0237 4-mg tablet administered twice daily

TRx0237 8 mg/day

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TauRx Therapeutics Ltd: lead

Study Sites (103)

Xenoscience

Phoenix, Arizona, 85004, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Imaging Endpoints Research

Scottsdale, Arizona, 85258, United States

Location

Atria Clinical Research

Little Rock, Arkansas, 72209, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

HB Clinical Trials Inc.

Fountain Valley, California, 92708, United States

Location

Fullerton Neurology and Headache Center

Fullerton, California, 92835, United States

Location

Senior Clinical Trials, Inc.

Laguna Hills, California, 92653, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

Sharp Mesa Vista Hospital

San Diego, California, 92123, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

California Neuroscience Medical Group

Sherman Oaks, California, 91403, United States

Location

Visionary Investigators Network

Aventura, Florida, 33180, United States

Location

Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Merrit Island Medical Research

Merritt Island, Florida, 32952, United States

Location

Health Care Family Rehab and Research

Miami, Florida, 33015, United States

Location

Optimus Clinical Research

Miami, Florida, 33125, United States

Location

Biomed Research Institute, Inc

Miami, Florida, 33126, United States

Location

Finlay Medical Research

Miami, Florida, 33126, United States

Location

CCM Clinical Research Group

Miami, Florida, 33133, United States

Location

Advance Medical Research Center

Miami, Florida, 33135, United States

Location

Vitae Research Center, LLC

Miami, Florida, 33135, United States

Location

L&C Professional Medical Research Institute

Miami, Florida, 33144, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Future Care Solution, LLC

Miami, Florida, 33165, United States

Location

Florida International Research Center

Miami, Florida, 33173, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Visionary Investigators Network

Miami, Florida, 33176, United States

Location

Sensible Healthcare

Ocoee, Florida, 34761, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

IMIC Inc

Palmetto Bay, Florida, 33157, United States

Location

Emerald Coast Center for Neurological Disorders

Pensacola, Florida, 32504, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

The Roskamp Institute, Inc.

Sarasota, Florida, 34243, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States

Location

NeuroStudies.net, LLC

Decatur, Georgia, 30033, United States

Location

Georgia Neurology and Sleep Medicine Associates

Suwanee, Georgia, 30024, United States

Location

Josephson Wallack Munshower Neurology P.C.

Indianapolis, Indiana, 46256, United States

Location

Advanced Memory Research of NJ PC

Toms River, New Jersey, 08755, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

UBMD Neurology

Buffalo, New York, 14203, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Alzheimer's Memory Center

Charlotte, North Carolina, 28270, United States

Location

Neuroscience Research Center, LLC

Canton, Ohio, 44718, United States

Location

Valley Medical Research

Centerville, Ohio, 45459, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Neurology Diagnostics Inc.

Dayton, Ohio, 45459, United States

Location

Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, 44321, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73106, United States

Location

Tulsa Clinical Research LLC

Tulsa, Oklahoma, 74136, United States

Location

Neural Net Research

Portland, Oregon, 97225, United States

Location

CBRI - Roper Hospital

Charleston, South Carolina, 29414, United States

Location

Coastal Neurology

Port Royal, South Carolina, 29935, United States

Location

Re:Cognition Health

Fairfax, Virginia, 22031, United States

Location

Kingfisher Cooperative, LLC

Spokane, Washington, 99202, United States

Location

Universal Research Group, LLC

Tacoma, Washington, 98405, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Okanagan Clinical Trials, Ltd.

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Memory Clinic (Ottawa)

Ottawa, Ontario, K1Z 1G3, Canada

Location

Clinique Mémoire de l'Outaouais

Gatineau, Quebec, J8T 8J1, Canada

Location

Alpha Recherche Clinique

Québec, G3K 2P8, Canada

Location

CHU Bordeaux - Pellegrin

Bordeaux, 33076, France

Location

Hôpital Neurologique Pierre Wertheimer

Bron, 69677, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Timone Adults Hospital

Marseille, 13385, France

Location

Guidechauliac Hospital

Montpellier, 34295, France

Location

Hôpital Laënnec - CHU de Nantes

Nantes, 44093, France

Location

CHU de Rennes

Rennes, 35009, France

Location

CRC Gerontopole Cite de la Sante, Hôpital La Grave

Toulouse, 31059, France

Location

Hopital des Charpennes

Villeurbanne, 69100, France

Location

IRCCS Centro S. Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Foundation Institute G.Giglio

Cefalù, 90015, Italy

Location

Azienda Ospedaliera San Gerardo - Clinica Neurologica

Monza, 20900, Italy

Location

Istituto Neurologico Casimiro Mondino, IRCCS

Pavia, 27100, Italy

Location

University of Perugia, Ospedale S.M. della Misericordia

Perugia, 06156, Italy

Location

Ospedale San Giovanni Calibita Fatebenefratelli

Roma, 00186, Italy

Location

Azienda Ospedaliera Sant'Andrea

Roma, 00189, Italy

Location

IRCCS Fondazione Santa Lucia

Rome, 00179, Italy

Location

Clinica Neurologica Santa Maria della Misericordia

Udine, 33100, Italy

Location

Podlaskie Centrum Psychogeriatrii

Bialystok, 15-756, Poland

Location

Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, 40-123, Poland

Location

Indywidualna Praktyka Lekarska

Lublin, 20-582, Poland

Location

NZOZ Neuro-Kard

Poznan, 61-853, Poland

Location

Euromedis Sp. z o.o.

Szczecin, 70-111, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

Location

Hospital General de Catalunya

Barcelona, 08195, Spain

Location

Hospitales de Madrid

Madrid, 28015, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario QuironSalud Madrid

Madrid, 28223, Spain

Location

Centro de salud de San Juan, Unidad de Investigación Neurociencias

Salamanca, 37005, Spain

Location

Hospital Virgen de la Macarena

Seville, 41009, Spain

Location

Hospital Universitario Mutua Terrassa

Terrassa, 08222, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Re:Cognition Health

Birmingham, B16 8LT, United Kingdom

Location

Glasgow Memory Clinic Ltd

Glasgow, G20 0XA, United Kingdom

Location

Re:Cognition Health

Guildford, GU2 7YD, United Kingdom

Location

Re:Cognition Health - Central London

London, W1G 9JF, United Kingdom

Location

Re:Cognition Health

Plymouth, PL6 8BT, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

hydromethylthionine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Sotereos Gates, PhD
• Organization: TauRx Therapeutics Management Ltd.

s.gates@taurx.com

+44 (0) 7771 570707

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 26, 2018
• Study Start: December 1, 2017
• Primary Completion: March 31, 2022
• Study Completion: April 4, 2023
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Locations

BE (1); CA (4); PL (7); ES (8); IT (9); US (60); FR (9); GB (5)