Alzheimer DiseasePhase 3NCT03446001
Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment
A Phase 3 study testing TRx0237 16 mg/day and TRx0237 8 mg/day in people with Alzheimer Disease, run by TauRx Therapeutics Ltd at 103 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- TRx0237 16 mg/day and TRx0237 8 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 598 participants
- Where
- 103 sitesin 8 countries
- Study dates
- 1 Dec 2017to 4 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
103 sites in 8 countries.
103 sites in 8 countries
United States60 sites
Albany Medical College
Albany, New York, 12208
Visionary Investigators Network
Aventura, Florida, 33180
UBMD Neurology
Buffalo, New York, 14203
Neuroscience Research Center, LLC
Canton, Ohio, 44718
Valley Medical Research
Centerville, Ohio, 45459
CBRI - Roper Hospital
Charleston, South Carolina, 29414
Alzheimer's Memory Center
Charlotte, North Carolina, 28270
The Lindner Research Center
Cincinnati, Ohio, 45219
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
Neurology Diagnostics Inc.
Dayton, Ohio, 45459
NeuroStudies.net, LLC
Decatur, Georgia, 30033
Re:Cognition Health
Fairfax, Virginia, 22031
HB Clinical Trials Inc.
Fountain Valley, California, 92708
Fullerton Neurology and Headache Center
Fullerton, California, 92835
Finlay Medical Research
Greenacres City, Florida, 33467
MD Clinical
Hallandale, Florida, 33009
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, 46256
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653
Atria Clinical Research
Little Rock, Arkansas, 72209
Merrit Island Medical Research
Merritt Island, Florida, 32952
Health Care Family Rehab and Research
Miami, Florida, 33015
Optimus Clinical Research
Miami, Florida, 33125
Biomed Research Institute, Inc
Miami, Florida, 33126
Finlay Medical Research
Miami, Florida, 33126
CCM Clinical Research Group
Miami, Florida, 33133
Advance Medical Research Center
Miami, Florida, 33135
Vitae Research Center, LLC
Miami, Florida, 33135
L&C Professional Medical Research Institute
Miami, Florida, 33144
Allied Biomedical Research Institute
Miami, Florida, 33155
Future Care Solution, LLC
Miami, Florida, 33165
Florida International Research Center
Miami, Florida, 33173
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
Visionary Investigators Network
Miami, Florida, 33176
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44321
Excell Research, Inc.
Oceanside, California, 92056
Sensible Healthcare
Ocoee, Florida, 34761
IPS Research Company
Oklahoma City, Oklahoma, 73106
Bioclinica Research
Orlando, Florida, 32806
IMIC Inc
Palmetto Bay, Florida, 33157
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32504
Xenoscience
Phoenix, Arizona, 85004
Arizona Research Center
Phoenix, Arizona, 85053
Progressive Medical Research
Port Orange, Florida, 32127
Coastal Neurology
Port Royal, South Carolina, 29935
Neural Net Research
Portland, Oregon, 97225
Sharp Mesa Vista Hospital
San Diego, California, 92123
Syrentis Clinical Research
Santa Ana, California, 92705
The Roskamp Institute, Inc.
Sarasota, Florida, 34243
Imaging Endpoints Research
Scottsdale, Arizona, 85258
California Neuroscience Medical Group
Sherman Oaks, California, 91403
Kingfisher Cooperative, LLC
Spokane, Washington, 99202
Richmond Behavioral Associates
Staten Island, New York, 10312
Georgia Neurology and Sleep Medicine Associates
Suwanee, Georgia, 30024
Universal Research Group, LLC
Tacoma, Washington, 98405
Stedman Clinical Trials
Tampa, Florida, 33613
Advanced Memory Research of NJ PC
Toms River, New Jersey, 08755
Tulsa Clinical Research LLC
Tulsa, Oklahoma, 74136
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414
France9 sites
CHU Bordeaux - Pellegrin
Bordeaux, 33076
Hôpital Neurologique Pierre Wertheimer
Bron, 69677
CHU de Limoges
Limoges, 87042
Timone Adults Hospital
Marseille, 13385
Guidechauliac Hospital
Montpellier, 34295
Hôpital Laënnec - CHU de Nantes
Nantes, 44093
CHU de Rennes
Rennes, 35009
CRC Gerontopole Cite de la Sante, Hôpital La Grave
Toulouse, 31059
Hopital des Charpennes
Villeurbanne, 69100
Italy9 sites
IRCCS Centro S. Giovanni di Dio Fatebenefratelli
Brescia, 25125
Foundation Institute G.Giglio
Cefalù, 90015
Azienda Ospedaliera San Gerardo - Clinica Neurologica
Monza, 20900
Istituto Neurologico Casimiro Mondino, IRCCS
Pavia, 27100
University of Perugia, Ospedale S.M. della Misericordia
Perugia, 06156
Ospedale San Giovanni Calibita Fatebenefratelli
Roma, 00186
Azienda Ospedaliera Sant'Andrea
Roma, 00189
IRCCS Fondazione Santa Lucia
Rome, 00179
Clinica Neurologica Santa Maria della Misericordia
Udine, 33100
Spain8 sites
Hospital General de Catalunya
Barcelona, 08195
Hospitales de Madrid
Madrid, 28015
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario QuironSalud Madrid
Madrid, 28223
Centro de salud de San Juan, Unidad de Investigación Neurociencias
Salamanca, 37005
Hospital Virgen de la Macarena
Seville, 41009
Hospital Universitario Mutua Terrassa
Terrassa, 08222
Hospital Universitario Doctor Peset
Valencia, 46017
Poland7 sites
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
Centrum Medyczne NEUROMED
Bydgoszcz, 85-163
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice, 40-123
Indywidualna Praktyka Lekarska
Lublin, 20-582
NZOZ Neuro-Kard
Poznan, 61-853
Euromedis Sp. z o.o.
Szczecin, 70-111
Centrum Medyczne NeuroProtect
Warsaw, 01-684
United Kingdom5 sites
Re:Cognition Health
Birmingham, B16 8LT
Glasgow Memory Clinic Ltd
Glasgow, G20 0XA
Re:Cognition Health
Guildford, GU2 7YD
Re:Cognition Health - Central London
London, W1G 9JF
Re:Cognition Health
Plymouth, PL6 8BT
Canada4 sites
Clinique Mémoire de l'Outaouais
Gatineau, Quebec, J8T 8J1
Okanagan Clinical Trials, Ltd.
Kelowna, British Columbia, V1Y 1Z9
Memory Clinic (Ottawa)
Ottawa, Ontario, K1Z 1G3
Alpha Recherche Clinique
Québec, G3K 2P8
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment
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
- Being tested
- TRx0237 16 mg/day, Control, TRx0237 8 mg/day
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRx0237 16 mg/dayDrug
Oral TRx0237 4-mg tablets administered twice daily
ControlDrug
Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
TRx0237 8 mg/dayDrug
Oral TRx0237 4-mg tablet administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| TRx0237 16 mg/day | Experimental | Not described Receives: Drug: TRx0237 16 mg/day |
| Control | Placebo comparator | Not described Receives: Drug: Control |
| TRx0237 8 mg/day | Experimental | Not described Receives: Drug: TRx0237 8 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 52 weeks
Secondary outcomes (10)
Change in Annualized Rate of Whole Brain Atrophy (16 mg/Day vs Control)
This secondary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group.
Measured: 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)
This secondary outcome measure (normalized to pons) was assessed in the TRx0237 16 mg/day dose group compared to the control group, and restricted to subjects with Clinical Dementia Rating (CDR) 0.5 at Screening.
Measured: 52 weeks
Change in Annualized Rate of Temporoparietal Lobe Atrophy (16 mg/Day vs Control)
This secondary outcome measure was assessed in the TRx0237 16mg/day group compared to the control group.
Measured: 52 weeks
Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (8 mg/Day vs Control)
This secondary outcome measure was assessed in the TRx0237 8 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).
Note: Estimates for the Control Arm in the primary outcome and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Measured: 52 weeks
Change From Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (8 mg/Day vs Control)
This secondary outcome measure was assessed in the TRx0237 8 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).
Note: Estimates for the Control Arm in the primary outcome and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Measured: 52 weeks
Change in Standardized Uptake Value Ratio (SUVR) Based on Temporal Lobe 18F-fluorodeoxyglucose Positron Emission Tomography (18F-FDG-PET) (8 mg/Day vs Control)
This secondary outcome measure was assessed in the TRx0237 8mg/day dose group compared to the control group, and restricted to subjects with Clinical Dementia Rating (CDR) 0.5 at Screening.
Note: Estimates for the Control Arm in the TRx0237 16 mg/day dose group comparison and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Measured: 52 weeks
Change in Annualized Rate of Temporoparietal Lobe Atrophy (8 mg/Day vs Control)
This secondary outcome measure was assessed in the TRx0237 8 mg/day dose group compared to the control group.
Note: Estimates for the Control Arm in the TRx0237 16 mg/day dose group comparison and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Measured: 52 weeks
Change From Open-Label Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
This secondary outcome measure was assessed for the open-label period of the study comparing subjects originally randomized to placebo to subjects originally randomized to either dose of TRx0237. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).
Note: It was prespecified to combine subjects who received TRx0237 8 mg/day or TRx0237 16 mg/day in the double-blind phase as early starters; thus these are combined for this comparison.
Measured: 104 weeks
Number of Study Participants With Serious and Non-serious Adverse Events (8 mg/Day vs Control)
This secondary outcome measure was assessed in the TRx0237 8 mg/day group compared to the control group over 52 weeks. All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator were to be reported as adverse events.
Measured: 52 weeks
Number of Study Participants With Serious and Non-serious Adverse Events (Open-label)
This secondary outcome measure was assessed for all subjects receiving TRx0237 in the open-label phase of the study (in which subjects had received TRx0237 for up to 104 weeks).
Note: Subjects who received TRx0237 8 mg/day or TRx0237 16 mg/day arms in the double-blind phase are combined for this comparison as all had previously received TRx0237 as compared to those subjects in the control arm who were receiving TRx0237 for the first time in the open-label phase.
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Dec 2017
- Primary completion31 Mar 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- TauRx Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446001
- Sponsor's protocol ID
- TRx-237-039
- Status last verified
- Aug 2025
- First submitted
- 8 Feb 2018
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment
- ClinicalTrials.gov ID
- NCT03446001
- Acronym / sponsor ID
- TRx-237-039
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- TauRx Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRx0237 16 mg/dayOral TRx0237 4-mg tablets administered twice daily | Drug | TRx0237 16 mg/day |
| ControlOral placebo tablets (some of which contain a urinary discolorant) administered twice daily | Drug | Control |
| TRx0237 8 mg/dayOral TRx0237 4-mg tablet administered twice daily | Drug | TRx0237 8 mg/day |
Primary outcome
Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (16 mg/Day vs Control)
Time frame: 52 weeks
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).
Change From Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (16 mg/Day vs Control)
Time frame: 52 weeks
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).
Number of Study Participants With Serious and Non-serious Adverse Events (16 mg/Day vs Control)
Time frame: 52 weeks
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.
10 secondary outcomes
Change in Annualized Rate of Whole Brain Atrophy (16 mg/Day vs Control)
Time frame: 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)
Time frame: 52 weeks
Change in Annualized Rate of Temporoparietal Lobe Atrophy (16 mg/Day vs Control)
Time frame: 52 weeks
Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (8 mg/Day vs Control)
Time frame: 52 weeks
Change From Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (8 mg/Day vs Control)
Time frame: 52 weeks
Change in Standardized Uptake Value Ratio (SUVR) Based on Temporal Lobe 18F-fluorodeoxyglucose Positron Emission Tomography (18F-FDG-PET) (8 mg/Day vs Control)
Time frame: 52 weeks
Change in Annualized Rate of Temporoparietal Lobe Atrophy (8 mg/Day vs Control)
Time frame: 52 weeks
Change From Open-Label Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
Time frame: 104 weeks
Number of Study Participants With Serious and Non-serious Adverse Events (8 mg/Day vs Control)
Time frame: 52 weeks
Number of Study Participants With Serious and Non-serious Adverse Events (Open-label)
Time frame: 104 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
103 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRx0237 16 mg/day and TRx0237 8 mg/day in people with Alzheimer Disease, run by TauRx Therapeutics Ltd at 103 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, France, Italy, Spain, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (16 mg/Day vs Control) (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.