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TRx0237 for Mild Alzheimer's Disease

Completed

The purpose of this Phase III study is to determine the safety and efficacy of the experimental drug TRx0237 to treat people with mild Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
N/A 89 Years Both No
November 2012
July 2015
500

Participants with Alzheimer's Disease

  • Diagnosis of dementia and probable Alzheimer's disease
  • Clinical dementia rating (CDR) total score of 0.5 to 1; MMSE score of 20 to 26 (inclusive); modified Hachinski ischemic score of 4 or less
  • Women of child-bearing potential must use adequate contraception or practice sexual abstinence throughout the study
  • If taking an acetylcholinesterase inhibitor and/or memantine at the time of screening, the participant must have been taking such medication(s) for at least 3 months and must have been on a stable dose for 6 weeks or more

Caregivers

  • Willing to provide written informed consent for own participation
  • Able to read, understand, and speak the designated language at the study site
  • Lives with the person with Alzheimer's or sees him/her for at least 2 hours per day on three or more days per week
  • Agrees to accompany the participant to each study visit
  • Able to verify daily compliance with the study drug

  • Significant central nervous system 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
  • Epilepsy, major depressive disorder, schizophrenia, bipolar disorder, substance abuse disorder
  • Metal implants in the head (except dental), pacemaker, cochlear implants, or any other nonremovable items that contraindicate magnetic resonance imaging; compatible prosthetics, clips, stents, or any other device proven to be compatible will be allowed
  • 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 or current significant hematological abnormality
  • Abnormal lab test results as deemed 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
  • Diagnosis of cancer within the past 2 years (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
  • Prohibited medications: Tacrine; anxiolytics, sedatives, or hypnotics taken before cognitive testing (exceptions: sedation for imaging or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime); clozapine; olanzapine; carbamazepine; primidone; drugs known to pose more than a very rare risk of methemoglobinemia at approved dose
  • Current or prior participation in a Phase III clinical trial of a product for cognition in which the last dose was received within 90 days before screening (unless confirmed to have been randomized to placebo) or participation in a clinical trial of a drug, biologic, device, or medical food in which the last dose/administration was received within the past 28 days

In this study, researchers will test the drug TRx0237 (also called LMTX™) as a treatment for mild Alzheimer's disease. Results of cognitive testing will be compared between participants receiving the drug (100 mg twice daily) and those taking a placebo. The drug acts by reducing levels of aggregated or misfolded tau proteins, which are associated with the progressive neurodegeneration of Alzheimer’s disease.

For more information about this trial or study sites, contact Karen Pozzie at 1-800-910-5609 or info@alzheimersstudies.net.

Name City State Zip Status Primary Contact
Xenoscience, Inc / 21st Century Neurology
Phoenix Arizona 85004

NoesisPharma Clinical Trials
Phoenix Arizona 85032

CITrials
Bellflower California 90706

ATP Clinical Research, Inc.
Costa Mesa California 92626

Southern California Research, LLC
Fountain Valley California 92708

Feldman, Robert MD
Laguna Hills California 92653

Synergy East
Lemon Grove California 91945

Collaborative Neuroscience Network
Long Beach California 90806

Neuro-Therapeutics, Inc.
Pasadena California 91105

Anderson Clinical Research
Redlands California 92374

Pacific Research Network
San Diego California 92103

San Francisco Clinical Research Center
San Francisco California 94118

Neurological Research Institute
Santa Monica California 90404

Schuster Medical Research Institute
Sherman Oaks California 91403

Mile High Research Center
Denver Colorado 80218

Institute for Neurodegenerative Disorders
New Haven Connecticut 06510

Coastal Connecticut Research, LLC
New London Connecticut 06320

Research Center for Clinical Studies, Inc
Norwalk Connecticut 06851

JEM Research
Atlantis Florida 33462

Bradenton Research Center
Bradenton Florida 34205

Meridien Research
Brooksville Florida 34601

Brain Matters Research
Delray Beach Florida 33445

MD Clinical
Hallandale Beach Florida 33009

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449

Compass Research, LLC
Orlando Florida 32806

The Roskamp Institute, Inc.
Sarasota Florida 34243

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

Premiere Research Institute (Palm Beach Neurology)
West Palm Beach Florida 33407

Atlanta Center for Medical Research
Atlanta Georgia 30331

Neurostudies.net
Decatur Georgia 30033

Alexian Brothers Neurosciences Institute
Elk Grove Illinois 60007

Ruan Neurology Clinic and Research Center
Des Moines Iowa 50314

CBH Health, LLC
Rockville Maryland 20850

Quest Research Institute
Farmington Hills Michigan 48334

Neurological Research Center - Hattiesburg Clinic
Hattiesburg Mississippi 39401

Olive Branch Family Medical
Olive Branch Mississippi 38654

Millennium Psychiatric Associates
Creve Coeur Missouri 63141

Memory Enhancement Centers of America, Inc
Eatontown New Jersey 07724

Advanced Memory Research Institute of NJ PC
Toms River New Jersey 08757

Albuquerque Neuroscience
Albuquerque New Mexico 87109

Neurological Associates of Albany, P. C.
Albany New York 12208

MedicalPsych Care, PLLC
Elmsford New York 10523

Columbia University Taub Institute
New York New York 10032

Research Foundation for Mental Hygiene, Inc.
Orangeburg New York 10962

Wake Research Associates
Raleigh North Carolina 27612

Clinical Trials of America, Inc
Winston-Salem North Carolina 27103

Neurobehavorial Clinical Research
Canton Ohio 44718

Oklahoma Clinical Research Center
Oklahoma City Oklahoma 73112

The Clinical Trial Center, LLC
Jenkintown Pennsylvania 19046

RI Hospital
Providence Rhode Island 02903

Neurology Clinic, P.C.
Cordova Tennessee 38018

Clinical Neuroscience Solutions CNS Healthcare
Memphis Tennessee 38119

Senior Adults Specialty Research, Inc.
Austin Texas 78757

FutureSearch Trials of Dallas, LP
Dallas Texas 75231

PRA Health Sciences
Salt Lake City Utah 84107

Independent Psychiatric Consultants
Waukesha Wisconsin 53188

University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver British Columbia V6T 1Z3

Parkwood Institute
London Ontario N6C 0A7

Toronto Memory Program
Toronto Ontario M3B 2S7

Jewish General Hospital
Montreal Quebec H3T 1E2

TauRx Therapeutics Ltd.

Name Phone Email
Kim Lee 1-800-910-5609 info@alzheimersstudies.net

NCT01689233

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