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Alzheimer's DiseasePhase 3NCT01689233

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease

A Phase 3 study testing TRx0237 200 mg/day in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd at 95 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild Alzheimer's Disease. Read more about this study

Who is it for?
Ages Up to 89 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
TRx0237 200 mg/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
95 sitesin 12 countries
Study dates
Oct 2012to May 2016
Phase
Phase 3
Are there results?
None posted in the registry

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 89 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of all cause dementia and probable Alzheimer's disease
  • Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild) and MMSE score of 20-26 (inclusive)
  • Age <90 years
  • Modified Hachinski ischemic score of ≤4
  • Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
  • Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent
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  • Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
  • If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
  • Able to comply with the study procedures

Who cannot join

  • Significant central nervous system (CNS) disorder other than Alzheimer's disease
  • Significant focal or vascular intracranial pathology seen on brain MRI scan
  • Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
  • Epilepsy
  • Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
  • Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
Show all 25Show fewer
  • Resides in hospital or moderate to high dependency continuous care facility
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Glucose-6-phosphate dehydrogenase 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 relevant by the investigator
  • Clinically significant cardiovascular disease or abnormal assessments
  • Preexisting or current signs or symptoms of respiratory failure
  • Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
  • Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
  • Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
  • Treatment currently or within 3 months before Baseline with any of the following medications (unless otherwise noted):
  • Tacrine
  • Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
  • Carbamazepine, primidone
  • Drugs with a warning or precaution in the labeling of methemoglobinemia at approved doses
  • Current or prior participation in a clinical trial as follows:
  • Clinical trial of a product for cognition in which the last dose was received within 90 days prior to Screening (unless confirmed to have been randomized to placebo)
  • A clinical trial of a drug, biologic, device, or medical food in which the last dose/administration was received within 28 days prior to Baseline

Trial locations and contacts

95 sites in 12 countries.

95 sites in 12 countries

United States58 sites

  • Neurological Associates of Albany, P. C.

    Albany, New York, 12208

  • Albuquerque Neuroscience

    Albuquerque, New Mexico, 87109

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • JEM Research

    Atlantis, Florida, 33462

  • Senior Adults Specialty Research, Inc.

    Austin, Texas, 78757

  • CITrials

    Bellflower, California, 90706

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • Meridien Research

    Brooksville, Florida, 34601

  • Neurobehavorial Clinical Research

    Canton, Ohio, 44718

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Millennium Psychiatric Associates

    Creve Coeur, Missouri, 63141

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Neurostudies.net

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Ruan Neurology Clinic and Research Center

    Des Moines, Iowa, 50314

  • Memory Enhancement Centers of America, Inc

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neurosciences Institute

    Elk Grove, Illinois, 60007

  • MedicalPsych Care, PLLC

    Elmsford, New York, 10523

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Southern California Research, LLC

    Fountain Valley, California, 92708

  • MD Clinical

    Hallandale, Florida, 33009

  • Neurological Research Center - Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Feldman, Robert MD

    Laguna Hills, California, 92653

  • Alzheimer's Research and Treatment Center

    Lake Worth, Florida, 33449

  • Synergy East

    Lemon Grove, California, 91945

  • Collaborative Neuroscience Network

    Long Beach, California, 90806

  • Clinical Neuroscience Solutions CNS Healthcare

    Memphis, Tennessee, 38119

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Columbia University Taub Institute

    New York, New York, 10032

  • Research Center for Clinical Studies, Inc

    Norwalk, Connecticut, 06851

  • Oklahoma Clinical Research Center

    Oklahoma City, Oklahoma, 73112

  • Olive Branch Family Medical

    Olive Branch, Mississippi, 38654

  • Research Foundation for Mental Hygiene, Inc.

    Orangeburg, New York, 10962

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Neuro-Therapeutics, Inc.

    Pasadena, California, 91105

  • Xenoscience, Inc / 21st Century Neurology

    Phoenix, Arizona, 85004

  • NoesisPharma Clinical Trials

    Phoenix, Arizona, 85032

  • RI Hospital

    Providence, Rhode Island, 02903

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Anderson Clinical Research

    Redlands, California, 92374

  • CBH Health, LLC

    Rockville, Maryland, 20850

  • PRA Health Sciences

    Salt Lake City, Utah, 84107

  • Pacific Research Network

    San Diego, California, 92103

  • San Francisco Clinical Research Center

    San Francisco, California, 94118

  • Neurological Research Institute

    Santa Monica, California, 90404

  • The Roskamp Institute, Inc.

    Sarasota, Florida, 34243

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida, 33613

  • Compass Research, LLC - North Clinic

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of NJ PC

    Toms River, New Jersey, 08757

  • Independent Psychiatric Consultants

    Waukesha, Wisconsin, 53188

  • Premiere Research Institute (Palm Beach Neurology)

    West Palm Beach, Florida, 33407

  • Clinical Trials of America, Inc

    Winston-Salem, North Carolina, 27103

Other trials in United States

Belgium5 sites

  • University Hospital Brussels Department of Neurology

    Brussels, 1090

  • University Hospital Gent Department of Neurology

    Ghent, 9000

  • Jessa Hospital

    Hasselt, 3500

  • Regional Hospital Sint-Trudo

    Sint-Truiden, 3800

  • GasthuisZusters Antwerpen Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Germany5 sites

  • Neurozentrum Achim Dr. med. Andreas Mahler

    Achim, 28832

  • University Medicine Berlin - Charité, CBF, Neurology

    Berlin, 12200

  • Memory Clinic, ECRC

    Berlin, 13125

  • Arzeneimittelforschung Leipzig GmbH

    Leipzig, 04107

  • Klinik und Poliklinik für Psychiatrie und Psychotherapie Zentrum für Nervenheilkunde - Universitätsklinikum Rostock

    Rostock, 18147

Other trials in Germany

Italy5 sites

  • A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

    Ancona, 60126

  • IRCCS San Giovanni di Dio - Fatebenefratelli

    Brescia, 25125

  • Fondazione Universita 'G. D'Annunzio di Chieti

    Chieti Scalo, 66100

  • Clinical Neurology Department of Neuroscience (DINOGMI) - University of Genoa

    Genova, 16132

  • Azienda Ospedaliera Universitaria Sant'Andrea di Roma - Unita' di Neurologia

    Roma, 00189

Other trials in Italy

United Kingdom5 sites

  • Grampian NHS, Royal Cornhill Hospital

    Aberdeen, AB25 2ZH

  • Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit

    Crowborough, TN6 1HB

  • Re:Cogniton Health

    London, W1G 9JF

  • Memory Assessment and Research Centre (MARC)

    Southampton, SO30 3JB

  • Kingshill Research Centre, Victoria Hospital

    Swindon, SN3 6BW

Other trials in United Kingdom

Canada4 sites

  • Parkwood Institute

    London, Ontario, N6C 0A7

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

Spain4 sites

  • Fundacio ACE

    Barcelona, 08028

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitari Mútua de Terrassa

    Terrassa, 08221

Other trials in Spain

France3 sites

  • Hôpitaux Civils de Colmar

    Colmar, 68024

  • Hôpital La Grave

    Toulouse, 31059

  • Hôpital de Charpennes

    Villeurbanne, 69100

Other trials in France

Croatia2 sites

  • University Hospital Centre Zagreb, Department of Neurology

    Zagreb, 10000

  • University Psychiatric Hospital Vrapče

    Zagreb, 10090

Other trials in Croatia

Finland2 sites

  • University of Eastern Finland, Brain Research Unit Mediteknia

    Kuopio, 70210

  • Clinical Research Services Turku (CRST)

    Turku, 20520

Other trials in Finland

Australia1 site

  • Discipline of Psychiatry, University of Queensland

    Herston, Queensland, 4029

Other trials in Australia

Netherlands1 site

  • Alzheimer Center Southwest Netherlands, Erasmus MC

    Rotterdam, 3015

Other trials in Netherlands

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild Alzheimer's Disease.

Being tested
TRx0237 200 mg/day, Placebo
Keywords
Alzheimer's Disease, Alzheimer Disease, TRx0237, AD, Neurodegenerative Diseases, Dementia, Brain Diseases
Medical subject headings
Alzheimer Disease, Neurodegenerative Diseases, Dementia, Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRx0237 200 mg/dayDrug

    TRx0237 100 mg tablets will be administered twice daily.

  • PlaceboDrug

    Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.

Study groups in NCT01689233
Study groupRoleWhat they receive
TRx0237 200 mg/dayExperimentalNot described
Receives: Drug: TRx0237 200 mg/day
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)

    Measured: 78 weeks

  2. Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)

    Measured: 78 weeks

  3. Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes

    Safety parameters include adverse events, vital signs, methemoglobin and oxygen saturation, physical and neurological examinations, laboratory tests (hematology, serum chemistry, and urinalysis), electrocardiograms, potential for serotonin toxicity, brain magnetic resonance imaging (MRI), and potential for suicide or self-harm.

    Measured: 78 weeks

Secondary outcomes (5)

  1. Change from Baseline in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

    Measured: 78 weeks

  2. Change from Baseline in Mini-Mental Status Examination (MMSE)

    Measured: 78 weeks

  3. Change from Baseline in Neuropsychiatric Inventory (NPI)

    Measured: 78 weeks

  4. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured: 78 weeks

  5. Change in expected decline of whole brain volume as measured by brain MRI

    Measured: 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01689233
Sponsor's protocol ID
TRx-237-005
Status last verified
Mar 2018
First submitted
14 Sep 2012
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TRx0237 200 mg/day in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd at 95 sites in 12 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 9 inclusion and 25 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Belgium, Germany, Italy, United Kingdom and 7 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (time frame: 78 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?

On the ClinicalTrials.gov record for NCT01689233.

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 14 Mar 2018.

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