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

August 14, 2025 updated by: TauRx Therapeutics Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
598

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
  • Canada
      • Québec, Canada, G3K 2P8
        • Alpha Recherche Clinique
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials, Ltd.
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Memory Clinic (Ottawa)
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Clinique Mémoire de l'Outaouais
  • France
      • Bordeaux, France, 33076
        • CHU Bordeaux - Pellegrin
      • Bron, France, 69677
        • Hopital Neurologique Pierre Wertheimer
      • Limoges, France, 87042
        • CHU de Limoges
      • Marseille, France, 13385
        • Timone Adults Hospital
      • Montpellier, France, 34295
        • Guidechauliac Hospital
      • Nantes, France, 44093
        • Hôpital Laënnec - CHU de Nantes
      • Rennes, France, 35009
        • CHU de Rennes
      • Toulouse, France, 31059
        • CRC Gerontopole Cite de la Sante, Hôpital La Grave
      • Villeurbanne, France, 69100
        • Hopital des Charpennes
  • Italy
      • Brescia, Italy, 25125
        • IRCCS Centro S. Giovanni di Dio Fatebenefratelli
      • Cefalù, Italy, 90015
        • Foundation Institute G.Giglio
      • Monza, Italy, 20900
        • Azienda Ospedaliera San Gerardo - Clinica Neurologica
      • Pavia, Italy, 27100
        • Istituto Neurologico Casimiro Mondino, IRCCS
      • Perugia, Italy, 06156
        • University of Perugia, Ospedale S.M. della Misericordia
      • Roma, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea
      • Roma, Italy, 00186
        • Ospedale San Giovanni Calibita Fatebenefratelli
      • Rome, Italy, 00179
        • Irccs Fondazione Santa Lucia
      • Udine, Italy, 33100
        • Clinica Neurologica Santa Maria della Misericordia
  • Poland
      • Bialystok, Poland, 15-756
        • Podlaskie Centrum Psychogeriatrii
      • Bydgoszcz, Poland, 85-163
        • Centrum Medyczne Neuromed
      • Katowice, Poland, 40-123
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
      • Lublin, Poland, 20-582
        • Indywidualna Praktyka Lekarska
      • Poznan, Poland, 61-853
        • NZOZ Neuro-Kard
      • Szczecin, Poland, 70-111
        • Euromedis Sp. z o.o.
      • Warsaw, Poland, 01-684
        • Centrum Medyczne NeuroProtect
  • Spain
      • Barcelona, Spain, 08195
        • Hospital General de Catalunya
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28223
        • Hospital Universitario Quirónsalud Madrid
      • Madrid, Spain, 28015
        • Hospitales de Madrid
      • Salamanca, Spain, 37005
        • Centro de salud de San Juan, Unidad de Investigación Neurociencias
      • Seville, Spain, 41009
        • Hospital Virgen de la Macarena
      • Terrassa, Spain, 08222
        • Hospital Universitario Mútua Terrassa
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset
  • United Kingdom
      • Birmingham, United Kingdom, B16 8LT
        • Re:Cognition Health
      • Glasgow, United Kingdom, G20 0XA
        • Glasgow Memory Clinic Ltd
      • Guildford, United Kingdom, GU2 7YD
        • Re:Cognition Health
      • London, United Kingdom, W1G 9JF
        • Re:Cognition Health - Central London
      • Plymouth, United Kingdom, PL6 8BT
        • Re:Cognition Health
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85004
        • Xenoscience
      • Scottsdale, Arizona, United States, 85258
        • Imaging Endpoints Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Atria Clinical Research
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research, Inc.
      • Fountain Valley, California, United States, 92708
        • HB Clinical Trials Inc.
      • Fullerton, California, United States, 92835
        • Fullerton Neurology and Headache Center
      • Laguna Hills, California, United States, 92653
        • Senior Clinical Trials, Inc.
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Oceanside, California, United States, 92056
        • Excell Research, Inc.
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Medical Group
    • Florida
      • Aventura, Florida, United States, 33180
        • Visionary Investigators Network
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research
      • Hallandale, Florida, United States, 33009
        • MD Clinical
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc.
      • Merritt Island, Florida, United States, 32952
        • Merrit Island Medical Research
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miami, Florida, United States, 33133
        • CCM Clinical Research Group
      • Miami, Florida, United States, 33155
        • Allied Biomedical Research Institute
      • Miami, Florida, United States, 33173
        • Florida International Research Center
      • Miami, Florida, United States, 33165
        • Future Care Solution, LLC
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research Institute, LLC
      • Miami, Florida, United States, 33135
        • Advance Medical Research Center
      • Miami, Florida, United States, 33135
        • Vitae Research Center, LLC
      • Miami, Florida, United States, 33144
        • L&C Professional Medical Research Institute
      • Miami, Florida, United States, 33176
        • Visionary Investigators Network
      • Miami, Florida, United States, 33126
        • Biomed Research Institute, Inc
      • Miami, Florida, United States, 33015
        • Health Care Family Rehab and Research
      • Miami, Florida, United States, 33125
        • Optimus Clinical Research
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare
      • Orlando, Florida, United States, 32806
        • Bioclinica Research
      • Palmetto Bay, Florida, United States, 33157
        • IMIC Inc
      • Pensacola, Florida, United States, 32504
        • Emerald Coast Center For Neurological Disorders
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sarasota, Florida, United States, 34243
        • The Roskamp Institute, Inc.
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • Wellington, Florida, United States, 33414
        • Alzheimer's Research and Treatment Center
    • Georgia
      • Decatur, Georgia, United States, 30033
        • NeuroStudies.net, LLC
      • Suwanee, Georgia, United States, 30024
        • Georgia Neurology and Sleep Medicine Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology P.C.
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research of NJ PC
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Buffalo, New York, United States, 14203
        • UBMD Neurology
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • Alzheimer's Memory Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuroscience Research Center, LLC
      • Centerville, Ohio, United States, 45459
        • Valley Medical Research
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Research Center
      • Dayton, Ohio, United States, 45459
        • Neurology Diagnostics Inc.
      • North Canton, Ohio, United States, 44321
        • Neuro-Behavioral Clinical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • IPS Research Company
      • Tulsa, Oklahoma, United States, 74136
        • Tulsa Clinical Research LLC
    • Oregon
      • Portland, Oregon, United States, 97225
        • Neural Net Research
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • CBRI - Roper Hospital
      • Port Royal, South Carolina, United States, 29935
        • Coastal Neurology
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Re:Cognition Health
    • Washington
      • Spokane, Washington, United States, 99202
        • Kingfisher Cooperative, LLC
      • Tacoma, Washington, United States, 98405
        • Universal Research Group, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Drug: Control
Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
Experimental: TRx0237 16 mg/day
Drug: TRx0237 16 mg/day
Oral TRx0237 4-mg tablets administered twice daily
Experimental: TRx0237 8 mg/day
Drug: TRx0237 8 mg/day
Oral TRx0237 4-mg tablet administered twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
52 weeks
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).
52 weeks
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.
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Annualized Rate of Whole Brain Atrophy (16 mg/Day vs Control)
Time Frame: 52 weeks
This secondary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group.
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
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.
52 weeks
Change in Annualized Rate of Temporoparietal Lobe Atrophy (16 mg/Day vs Control)
Time Frame: 52 weeks
This secondary outcome measure was assessed in the TRx0237 16mg/day group compared to the control group.
52 weeks
Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (8 mg/Day vs Control)
Time Frame: 52 weeks

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.
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

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.
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

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.
52 weeks
Change in Annualized Rate of Temporoparietal Lobe Atrophy (8 mg/Day vs Control)
Time Frame: 52 weeks

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.
52 weeks
Change From Open-Label Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
Time Frame: 104 weeks

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.
104 weeks
Number of Study Participants With Serious and Non-serious Adverse Events (8 mg/Day vs Control)
Time Frame: 52 weeks
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.
52 weeks
Number of Study Participants With Serious and Non-serious Adverse Events (Open-label)
Time Frame: 104 weeks

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.
104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TauRx Therapeutics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRx-237-039

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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