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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01689233
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : March 14, 2018
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: TRx0237 200 mg/day Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease
Study Start Date : October 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TRx0237 200 mg/day Drug: TRx0237 200 mg/day
TRx0237 100 mg tablets will be administered twice daily.

Placebo Comparator: Placebo Drug: Placebo
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.

Primary Outcome Measures :
  1. Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) [ Time Frame: 78 weeks ]
  2. Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) [ Time Frame: 78 weeks ]
  3. Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes [ Time Frame: 78 weeks ]
    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.

Secondary Outcome Measures :
  1. Change from Baseline in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 78 weeks ]
  2. Change from Baseline in Mini-Mental Status Examination (MMSE) [ Time Frame: 78 weeks ]
  3. Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: 78 weeks ]
  4. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 78 weeks ]
  5. Change in expected decline of whole brain volume as measured by brain MRI [ Time Frame: 78 weeks ]

Other Outcome Measures:
  1. Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite [ Time Frame: 78 weeks ]
  2. Change in cerebrospinal fluid biomarkers of Alzheimer's Disease in subjects who separately consent to lumbar puncture [ Time Frame: 78 weeks ]
  3. Compare the influence of Apolipoprotein E genotype on the primary and selected secondary outcomes in subjects by or for whom legally acceptable consent is separately provided [ Time Frame: 78 weeks ]
  4. Reduction in glucose uptake decline in the temporal lobe on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging [ Time Frame: 78 weeks ]
  5. Change in expected increase in ventricular volume as measured by brain MRI [ Time Frame: 78 weeks ]
  6. Change in expected decline in hippocampal volume as measured by brain MRI [ Time Frame: 78 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01689233

  Hide Study Locations
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United States, Arizona
Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, United States, 85004
NoesisPharma Clinical Trials
Phoenix, Arizona, United States, 85032
United States, California
Bellflower, California, United States, 90706
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
Southern California Research, LLC
Fountain Valley, California, United States, 92708
Feldman, Robert MD
Laguna Hills, California, United States, 92653
Synergy East
Lemon Grove, California, United States, 91945
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
Neuro-Therapeutics, Inc.
Pasadena, California, United States, 91105
Anderson Clinical Research
Redlands, California, United States, 92374
Pacific Research Network
San Diego, California, United States, 92103
San Francisco Clinical Research Center
San Francisco, California, United States, 94118
Neurological Research Institute
Santa Monica, California, United States, 90404
Schuster Medical Research Institute
Sherman Oaks, California, United States, 91403
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Coastal Connecticut Research, LLC
New London, Connecticut, United States, 06320
Research Center for Clinical Studies, Inc
Norwalk, Connecticut, United States, 06851
United States, Florida
JEM Research
Atlantis, Florida, United States, 33462
Bradenton Research Center
Bradenton, Florida, United States, 34205
Meridien Research
Brooksville, Florida, United States, 34601
Brain Matters Research
Delray Beach, Florida, United States, 33445
MD Clinical
Hallandale Beach, Florida, United States, 33009
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33449
Compass Research, LLC
Orlando, Florida, United States, 32806
The Roskamp Institute, Inc.
Sarasota, Florida, United States, 34243
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613
Compass Research, LLC - North Clinic
The Villages, Florida, United States, 32162
Premiere Research Institute (Palm Beach Neurology)
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Decatur, Georgia, United States, 30033
United States, Illinois
Alexian Brothers Neurosciences Institute
Elk Grove, Illinois, United States, 60007
United States, Iowa
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, United States, 50314
United States, Maryland
CBH Health, LLC
Rockville, Maryland, United States, 20850
United States, Michigan
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
United States, Mississippi
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Olive Branch Family Medical
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Memory Enhancement Centers of America, Inc
Eatontown, New Jersey, United States, 07724
Advanced Memory Research Institute of NJ PC
Toms River, New Jersey, United States, 08757
United States, New Mexico
Albuquerque Neuroscience
Albuquerque, New Mexico, United States, 87109
United States, New York
Neurological Associates of Albany, P. C.
Albany, New York, United States, 12208
MedicalPsych Care, PLLC
Elmsford, New York, United States, 10523
Columbia University Taub Institute
New York, New York, United States, 10032
Research Foundation for Mental Hygiene, Inc.
Orangeburg, New York, United States, 10962
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Clinical Trials of America, Inc
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Neurobehavorial Clinical Research
Canton, Ohio, United States, 44718
United States, Oklahoma
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
United States, Rhode Island
RI Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Neurology Clinic, P.C.
Cordova, Tennessee, United States, 38018
Clinical Neuroscience Solutions CNS Healthcare
Memphis, Tennessee, United States, 38119
United States, Texas
Senior Adults Specialty Research, Inc.
Austin, Texas, United States, 78757
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States, 75231
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84107
United States, Wisconsin
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States, 53188
Australia, Queensland
Discipline of Psychiatry, University of Queensland
Herston, Queensland, Australia, 4029
University Hospital Brussels Department of Neurology
Bruxelles, Belgium, 1090
University Hospital Gent Department of Neurology
Gent, Belgium, 9000
Jessa Hospital
Hasselt, Belgium, 3500
Regional Hospital Sint-Trudo
Sint-Truiden, Belgium, 3800
GasthuisZusters Antwerpen Sint-Augustinus
Wilrijk, Belgium, 2610
Canada, British Columbia
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, British Columbia, Canada, V6T 1Z3
Canada, Ontario
Parkwood Institute
London, Ontario, Canada, N6C 0A7
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
University Hospital Centre Zagreb, Department of Neurology
Zagreb, Croatia, 10000
University Psychiatric Hospital Vrapče
Zagreb, Croatia, 10090
University of Eastern Finland, Brain Research Unit Mediteknia
Kuopio, Finland, 70210
Clinical Research Services Turku (CRST)
Turku, Finland, 20520
Hôpitaux Civils de Colmar
Colmar Cedex, France, 68024
Hôpital La Grave
Toulouse, France, 31059
Hôpital de Charpennes
Villeurbanne, France, 69100
Neurozentrum Achim Dr. med. Andreas Mahler
Achim, Germany, 28832
University Medicine Berlin - Charité, CBF, Neurology
Berlin, Germany, 12200
Memory Clinic, ECRC
Berlin, Germany, 13125
Arzeneimittelforschung Leipzig GmbH
Leipzig, Germany, 04107
Klinik und Poliklinik für Psychiatrie und Psychotherapie Zentrum für Nervenheilkunde - Universitätsklinikum Rostock
Rostock, Germany, 18147
A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona, Italy, 60126
IRCCS San Giovanni di Dio - Fatebenefratelli
Brescia, Italy, 25125
Fondazione Universita 'G. D'Annunzio di Chieti
Chieti Scalo, Italy, 66100
Clinical Neurology Department of Neuroscience (DINOGMI) - University of Genoa
Genova, Italy, 16132
Azienda Ospedaliera Universitaria Sant'Andrea di Roma - Unita' di Neurologia
Roma, Italy, 00189
Alzheimer Center Southwest Netherlands, Erasmus MC
Rotterdam, Netherlands, 3015
Fundacio ACE
Barcelona, Spain, 08028
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitari Mútua de Terrassa
Terrassa, Spain, 08221
United Kingdom
Grampian NHS, Royal Cornhill Hospital
Aberdeen, United Kingdom, AB25 2ZH
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
Crowborough, United Kingdom, TN6 1HB
Re:Cogniton Health
London, United Kingdom, W1G 9JF
Memory Assessment and Research Centre (MARC)
Southampton, United Kingdom, SO30 3JB
Kingshill Research Centre, Victoria Hospital
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
TauRx Therapeutics Ltd

Additional Information:
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Responsible Party: TauRx Therapeutics Ltd Identifier: NCT01689233     History of Changes
Other Study ID Numbers: TRx-237-005
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by TauRx Therapeutics Ltd:
Alzheimer's Disease
Alzheimer Disease
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action