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

NCT01689233 | Completed Phase 3 DMC

• 1 other identifier: TRx-237-005
• Study Type: interventional
• Target: 800
• Locations: 12 countries
• Sites: 95

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Alzheimer Disease; TRx0237; AD; Neurodegenerative Diseases; Dementia; Brain Diseases

Outcome Measures

Primary Outcomes (3)

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

  78 weeks

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

  78 weeks

• 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.

  78 weeks

Secondary Outcomes (5)

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

  78 weeks

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

  78 weeks

• Change from Baseline in Neuropsychiatric Inventory (NPI)

  78 weeks

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

  78 weeks

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

  78 weeks

Other Outcomes (6)

• Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite

  78 weeks

• Change in cerebrospinal fluid biomarkers of Alzheimer's Disease in subjects who separately consent to lumbar puncture

  78 weeks

• 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

  78 weeks

Study Arms (2)

TRx0237 200 mg/day

EXPERIMENTAL

Drug: TRx0237 200 mg/day

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TRx0237 200 mg/day DRUG

TRx0237 100 mg tablets will be administered twice daily.

TRx0237 200 mg/day

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: Up to 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TauRx Therapeutics Ltd: lead

Study Sites (95)

Xenoscience, Inc / 21st Century Neurology

Phoenix, Arizona, 85004, United States

Location

NoesisPharma Clinical Trials

Phoenix, Arizona, 85032, United States

Location

CITrials

Bellflower, California, 90706, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Southern California Research, LLC

Fountain Valley, California, 92708, United States

Location

Feldman, Robert MD

Laguna Hills, California, 92653, United States

Location

Synergy East

Lemon Grove, California, 91945, United States

Location

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

Neuro-Therapeutics, Inc.

Pasadena, California, 91105, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94118, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Schuster Medical Research Institute

Sherman Oaks, California, 91403, United States

Location

Mile High Research Center

Denver, Colorado, 80218, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

Location

Research Center for Clinical Studies, Inc

Norwalk, Connecticut, 06851, United States

Location

JEM Research

Atlantis, Florida, 33462, United States

Location

Bradenton Research Center

Bradenton, Florida, 34205, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Alzheimer's Research and Treatment Center

Lake Worth, Florida, 33449, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

The Roskamp Institute, Inc.

Sarasota, Florida, 34243, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

Location

Compass Research, LLC - North Clinic

The Villages, Florida, 32162, United States

Location

Premiere Research Institute (Palm Beach Neurology)

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Neurostudies.net

Decatur, Georgia, 30033, United States

Location

Alexian Brothers Neurosciences Institute

Elk Grove, Illinois, 60007, United States

Location

Ruan Neurology Clinic and Research Center

Des Moines, Iowa, 50314, United States

Location

CBH Health, LLC

Rockville, Maryland, 20850, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Neurological Research Center - Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Olive Branch Family Medical

Olive Branch, Mississippi, 38654, United States

Location

Millennium Psychiatric Associates

Creve Coeur, Missouri, 63141, United States

Location

Memory Enhancement Centers of America, Inc

Eatontown, New Jersey, 07724, United States

Location

Advanced Memory Research Institute of NJ PC

Toms River, New Jersey, 08757, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, 87109, United States

Location

Neurological Associates of Albany, P. C.

Albany, New York, 12208, United States

Location

MedicalPsych Care, PLLC

Elmsford, New York, 10523, United States

Location

Columbia University Taub Institute

New York, New York, 10032, United States

Location

Research Foundation for Mental Hygiene, Inc.

Orangeburg, New York, 10962, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Clinical Trials of America, Inc

Winston-Salem, North Carolina, 27103, United States

Location

Neurobehavorial Clinical Research

Canton, Ohio, 44718, United States

Location

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

RI Hospital

Providence, Rhode Island, 02903, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

Clinical Neuroscience Solutions CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Senior Adults Specialty Research, Inc.

Austin, Texas, 78757, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84107, United States

Location

Independent Psychiatric Consultants

Waukesha, Wisconsin, 53188, United States

Location

Discipline of Psychiatry, University of Queensland

Herston, Queensland, 4029, Australia

Location

University Hospital Brussels Department of Neurology

Brussels, 1090, Belgium

Location

University Hospital Gent Department of Neurology

Ghent, 9000, Belgium

Location

Jessa Hospital

Hasselt, 3500, Belgium

Location

Regional Hospital Sint-Trudo

Sint-Truiden, 3800, Belgium

Location

GasthuisZusters Antwerpen Sint-Augustinus

Wilrijk, 2610, Belgium

Location

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

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Parkwood Institute

London, Ontario, N6C 0A7, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

University Hospital Centre Zagreb, Department of Neurology

Zagreb, 10000, Croatia

Location

University Psychiatric Hospital Vrapče

Zagreb, 10090, Croatia

Location

University of Eastern Finland, Brain Research Unit Mediteknia

Kuopio, 70210, Finland

Location

Clinical Research Services Turku (CRST)

Turku, 20520, Finland

Location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

Hôpital La Grave

Toulouse, 31059, France

Location

Hôpital de Charpennes

Villeurbanne, 69100, France

Location

Neurozentrum Achim Dr. med. Andreas Mahler

Achim, 28832, Germany

Location

University Medicine Berlin - Charité, CBF, Neurology

Berlin, 12200, Germany

Location

Memory Clinic, ECRC

Berlin, 13125, Germany

Location

Arzeneimittelforschung Leipzig GmbH

Leipzig, 04107, Germany

Location

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

Rostock, 18147, Germany

Location

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

Ancona, 60126, Italy

Location

IRCCS San Giovanni di Dio - Fatebenefratelli

Brescia, 25125, Italy

Location

Fondazione Universita 'G. D'Annunzio di Chieti

Chieti Scalo, 66100, Italy

Location

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

Genova, 16132, Italy

Location

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

Roma, 00189, Italy

Location

Alzheimer Center Southwest Netherlands, Erasmus MC

Rotterdam, 3015, Netherlands

Location

Fundacio ACE

Barcelona, 08028, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitari Mútua de Terrassa

Terrassa, 08221, Spain

Location

Grampian NHS, Royal Cornhill Hospital

Aberdeen, AB25 2ZH, United Kingdom

Location

Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit

Crowborough, TN6 1HB, United Kingdom

Location

Re:Cogniton Health

London, W1G 9JF, United Kingdom

Location

Memory Assessment and Research Centre (MARC)

Southampton, SO30 3JB, United Kingdom

Location

Kingshill Research Centre, Victoria Hospital

Swindon, SN3 6BW, United Kingdom

Location

Related Links

• Alzheimer's Survey

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Dementia; Brain Diseases

Interventions

hydromethylthionine

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 21, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

US (58); AU (1); IT (5); FI (2); GB (5); CA (4); BE (5); NL (1); DE (5); ES (4); FR (3); CR (2)