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Alzheimer's DiseasePhase 3NCT01689246

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

A Phase 3 study testing TRx0237 150 mg/day and TRx0237 250 mg/day in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd at 121 sites in 16 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 to moderate 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 150 mg/day and TRx0237 250 mg/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
891 participants
Where
121 sitesin 16 countries
Study dates
Jan 2013to Nov 2015
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 1 (mild) to 2 (moderate) and MMSE score of 14-26 (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
Show all 9Show fewer
  • 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, or 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:
  • 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 about methemoglobinemia at approved doses
  • Current or prior participation in a clinical trial as follows:
  • Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo)
  • A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline

Trial locations and contacts

121 sites in 16 countries.

121 sites in 16 countries

United States26 sites

  • Neurological Associates of Albany, P. C.

    Albany, New York, 12208

  • JEM Research

    Atlantis, Florida, 33462

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • SPRI

    Brooklyn, New York, 11235

  • Neurobehavioral Clinical Research

    Canton, Ohio, 44718

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Memory Enhancement Centers of America, Inc

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neurosciences Institute

    Elk Grove, Illinois, 60007

  • CNS Healthcare, Inc

    Jacksonville, Florida, 32256

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Feldman, Robert MD

    Laguna Hills, California, 92653

  • Compass Research, LLC-North Clinic

    Leesburg, Florida, 34748

  • University of Southern California

    Los Angeles, California, 90033

  • CRI Worldwide

    Marlton, New Jersey, 08053

  • ActivMed Practices & Research

    Methuen, Massachusetts, 01844

  • Miami Research Associates

    Miami, Florida, 33143

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Shankle Clinic and Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Olive Branch Family Medical

    Olive Branch, Mississippi, 38654

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Xenoscience, Inc/ 21st Century Neurology

    Phoenix, Arizona, 85004

  • Pacific Research Network

    San Diego, California, 92103

  • San Francisco Clinical Research Center

    San Francisco, California, 94118

  • The Cognitive Research Center of New Jersey

    Springfield, New Jersey, 07801

  • Advanced Memory Research Institute of NJ PC

    Toms River, New Jersey, 08757

Other trials in United States

United Kingdom13 sites

  • NHS Grampian, Department of Old Age Psychiatry Royal Cornhill Hospital

    Aberdeen, AB25 2ZH

  • RICE - The Research Institute for the Care of Older People

    Bath, BA1 3NG

  • Belfast Health and Social Care Trust (BHSCT)

    Belfast, BT12 6BA

  • The Barberry Centre

    Birmingham, B15 2SG

  • MAC Clinical Research Ltd

    Blackpool, FY2 0JH

  • MAC Clinical Research Ltd

    Bradford, BD3 0DQ

  • MAC Clinical Research Ltd

    Cannock, WS11 0BN

  • MAC Clinical Research Ltd

    Leeds, LS10 1DU

  • Re: Cognition Health Ltd.

    London, W1G 9JF

  • Charing Cross Hospital

    London, W6 8RF

  • Dementia Research Centre

    London, WC1N 3BG

  • MAC Clinical Research Ltd

    Manchester, M13 9NQ

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

South Korea10 sites

  • Dong-A Medical Center

    Busan, 602-715

  • Inha University Hospital

    Incheon, 400-711

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

  • Inje University Sanggye Paik Hospital

    Seoul, 139-707

  • Konkuk University Medical Center

    Seoul, 143-729

  • Seoul National University Boramae Medical Center

    Seoul, 156-707

Other trials in South Korea

Australia9 sites

  • Royal Adelaide Hospital Memory Trials Centre

    Adelaide, South Australia, 5000

  • Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital

    Heidelberg West, Victoria, 3081

  • Discipline of Psychiatry, University of Qld

    Herston, Queensland, 4006

  • Division of Rehabilitation and Aged Care

    Hornsby, New South Wales, 2077

  • Southern Neurology Pty Limited

    Kogarah, New South Wales, 2217

  • McCusker Alzheimer's Research Foundation Inc

    Nedlands, Western Australia, 6009

  • Neurodegenerative Disorders Research Pty Ltd

    Perth, Western Australia, 6005

  • Academic Department for Old Age Psychiatry, Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Memory Unit, Neurology, The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Italy9 sites

  • Neurologia Ospedale Maggiore Policlinico

    Milan, 20122

  • Istituto Neurologico Carlo Besta

    Milan, 20133

  • IRCCS Istituto neurologico Casimiro Mondino

    Pavia, 27100

  • Clinica Neurologica, Università di Perugia-Ospedale S. Maria della Misericordia

    Perugia, 06156

  • Universita' Cattolica del Sacro Cuore

    Roma, 00168

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

    Roma, 00189

  • Dipartimento di Neuroscienze Universita' di Torino

    Torino, 10126

  • Azienda Ospedaliera S.maria Della Misericordia

    Udine, 33100

  • U.O. Di Neurologia Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Poland9 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • Pallmed sp zoo prowadząca NZOZ Dom Sue Ryder; Centrum Psychoneurologii Wieku Podeszłego

    Bydgoszcz, 85-796

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

    Katowice, 40-123

  • Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska

    Mosina, 62-050

  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

    Poznan, 61-853

  • Euromedis Sp. z o.o.

    Szczecin, 70-111

  • Usługi Lekarskie Sp.c Palasik, Żabierek

    Warsaw, 00-669

  • mMED

    Warsaw, 01-697

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-106

Other trials in Poland

Romania8 sites

  • County Emergency Clinical Hospital Arad, Psychiatry Department

    Arad, 310022

  • CMDTA "Neomed"

    Brasov, 500283

  • University Emergency Central Military Hospital "Dr.Carol Davila", Psychiatry Department

    Bucharest, 010816

  • Psychomedical Consult

    Bucharest, 024072

  • Clinical Municipal Hospital "Dr. Gavril Curteanu", Psychiatry Department

    Oradea, 410154

  • Psychiatry Hospital "Dr. Gheorghe Preda", Center of Mental Health

    Sibiu, 550082

  • Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III

    Sibiu, 550082

  • Emergency Clinical County Hospital Sibiu, Neurology Department

    Sibiu, 550166

Other trials in Romania

Russia8 sites

  • Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"

    Moscow, 109388

  • Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department

    Moscow, 115522

  • Mental Health Research Center of the Russian Academy of Medical Sciences

    Moscow, 115522

  • CityClinical Hospital #34, City Scientific Practical Neurological Center

    Novosibirsk, 630054

  • City Geriatric Medical and Social Center

    Saint Petersburg, 190103

  • Saint Nicholas Psychiatric Hospital

    Saint Petersburg, 190121

  • Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev

    Saint Petersburg, 192019

  • State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"

    Yekaterinburg, 620030

Other trials in Russia

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua

  • Chang Gung Memorial Hospital, Kaohsiung

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • En Chu Kong Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • National Yang-Ming University School of Medicine

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

Malaysia4 sites

  • University Kuala Lumpur Royal College of Medicine

    Ipoh, 30450

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • University Malaya Medical Centre

    Kuala Lumpur, 50603

  • Taiping Hospital

    Taiping, 34000

Other trials in Malaysia

Singapore4 sites

  • National University Hospital (NUH)

    Singapore, 119223

  • National Neuroscience Institute (NNI)

    Singapore, 308433

  • Tan Tock Seng Hospital (TTSH)

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Spain4 sites

  • Hospital Universitario de Ceuta

    Ceuta, 51003

  • Hospital Reina Sofía

    Córdoba, 14011

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Viamed Montecanal

    Zaragoza, 50006

Other trials in Spain

Canada3 sites

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • True North Clinical Research Kentville Inc

    Kentville, Nova Scotia, B4N 4K9

  • Toronto Memory Program

    North York, Ontario, M3B 2S7

Other trials in Canada

Germany3 sites

  • Neurozentrum Achim Dr. med. Andreas Mahler

    Achim, 28832

  • Charité, University Medicine Berlin, CBF, Neurology

    Berlin, 12200

  • Memory Clinic, ECRC

    Berlin, 13125

Other trials in Germany

Bulgaria2 sites

  • UMHAT "Alexandrovska" Clinic of Neurology Diseases Department of Neurodegenerative and Immune and Infectious Diseases of Central Nervous System with Sector for Treatment of Neuroinfections

    Sofia, 1431

  • UMHAT "Alexandrovska" Clinic of Psychiatry First Department of Psychiatry

    Sofia, 1431

Other trials in Bulgaria

Croatia2 sites

  • University Hospital Centre Zagreb

    Zagreb, 10000

  • University Psychiatric Hospital Vrapce

    Zagreb, 10090

Other trials in Croatia

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

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

Being tested
TRx0237 150 mg/day, TRx0237 250 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 150 mg/dayDrug

    TRx0237 75 mg tablets will be administered twice daily.

  • TRx0237 250 mg/dayDrug

    TRx0237 125 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 NCT01689246
Study groupRoleWhat they receive
TRx0237 250 mg/dayExperimentalNot described
Receives: Drug: TRx0237 250 mg/day
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
TRx0237 150 mg/dayExperimentalNot described
Receives: Drug: TRx0237 150 mg/day

What is being measured

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

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

    Measured: 65 weeks

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

    Measured: 65 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 suicide and self-harm, brain magnetic resonance imaging (MRI), and potential for serotonin toxicity

    Measured: 65 weeks

Secondary outcomes (3)

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

    Measured: 65 weeks

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

    Measured: 65 weeks

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

    Measured: 39 weeks and 65 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 startJan 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

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
891 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01689246
Sponsor's protocol ID
TRx-237-015
Status last verified
Mar 2018
First submitted
14 Sep 2012
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Gauthier S, Feldman HH, Schneider LS, Wilcock GK, Frisoni GB, Hardlund JH, Moebius HJ, Bentham P, Kook KA, Wischik DJ, Schelter BO, Davis CS, Staff RT, Bracoud L, Shamsi K, Storey JM, Harrington CR, Wischik CM. Efficacy and safety of tau-aggregation inhibitor therapy in patients with mild or moderate Alzheimer's disease: a randomised, controlled, double-blind, parallel-arm, phase 3 trial. Lancet. 2016 Dec 10;388(10062):2873-2884. doi: 10.1016/S0140-6736(16)31275-2. Epub 2016 Nov 16.

    PubMed 27863809

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TRx0237 150 mg/day and TRx0237 250 mg/day in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd at 121 sites in 16 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 121 sites in United States, United Kingdom, South Korea, Australia, Italy and 11 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 on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (time frame: 65 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 NCT01689246, which also lists 1 linked publication.

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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Clinical Trial NCT01689246 | AzTrials