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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 n/a

NoesisPharma Clinical Trials
Phoenix Arizona 85032 n/a

CITrials
Bellflower California 90706 n/a

ATP Clinical Research, Inc.
Costa Mesa California 92626 n/a

Southern California Research, LLC
Fountain Valley California 92708 n/a

Feldman, Robert MD
Laguna Hills California 92653 n/a

Synergy East
Lemon Grove California 91945 n/a

Collaborative Neuroscience Network
Long Beach California 90806 n/a

Neuro-Therapeutics, Inc.
Pasadena California 91105 n/a

Anderson Clinical Research
Redlands California 92374 n/a

Pacific Research Network
San Diego California 92103 n/a

San Francisco Clinical Research Center
San Francisco California 94118 n/a

Neurological Research Institute
Santa Monica California 90404 n/a

Schuster Medical Research Institute
Sherman Oaks California 91403 n/a

Mile High Research Center
Denver Colorado 80218 n/a

Institute for Neurodegenerative Disorders
New Haven Connecticut 06510 n/a

Coastal Connecticut Research, LLC
New London Connecticut 06320 n/a

Research Center for Clinical Studies, Inc
Norwalk Connecticut 06851 n/a

JEM Research
Atlantis Florida 33462 n/a

Bradenton Research Center
Bradenton Florida 34205 n/a

Meridien Research
Brooksville Florida 34601 n/a

Brain Matters Research
Delray Beach Florida 33445 n/a

MD Clinical
Hallandale Beach Florida 33009 n/a

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449 n/a

Compass Research, LLC
Orlando Florida 32806 n/a

The Roskamp Institute, Inc.
Sarasota Florida 34243 n/a

Axiom Clinical Research of Florida
Tampa Florida 33609 n/a

USF Health Byrd Alzheimer's Institute
Tampa Florida 33613 n/a

Compass Research, LLC - North Clinic
The Villages Florida 32162 n/a

Premiere Research Institute (Palm Beach Neurology)
West Palm Beach Florida 33407 n/a

Atlanta Center for Medical Research
Atlanta Georgia 30331 n/a

Neurostudies.net
Decatur Georgia 30033 n/a

Alexian Brothers Neurosciences Institute
Elk Grove Illinois 60007 n/a

Ruan Neurology Clinic and Research Center
Des Moines Iowa 50314 n/a

CBH Health, LLC
Rockville Maryland 20850 n/a

Quest Research Institute
Farmington Hills Michigan 48334 n/a

Neurological Research Center - Hattiesburg Clinic
Hattiesburg Mississippi 39401 n/a

Olive Branch Family Medical
Olive Branch Mississippi 38654 n/a

Millennium Psychiatric Associates
Creve Coeur Missouri 63141 n/a

Memory Enhancement Centers of America, Inc
Eatontown New Jersey 07724 n/a

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

Albuquerque Neuroscience
Albuquerque New Mexico 87109 n/a

Neurological Associates of Albany, P. C.
Albany New York 12208 n/a

MedicalPsych Care, PLLC
Elmsford New York 10523 n/a

Columbia University Taub Institute
New York New York 10032 n/a

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

Wake Research Associates
Raleigh North Carolina 27612 n/a

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

Neurobehavorial Clinical Research
Canton Ohio 44718 n/a

Oklahoma Clinical Research Center
Oklahoma City Oklahoma 73112 n/a

The Clinical Trial Center, LLC
Jenkintown Pennsylvania 19046 n/a

RI Hospital
Providence Rhode Island 02903 n/a

Neurology Clinic, P.C.
Cordova Tennessee 38018 n/a

Clinical Neuroscience Solutions CNS Healthcare
Memphis Tennessee 38119 n/a

Senior Adults Specialty Research, Inc.
Austin Texas 78757 n/a

FutureSearch Trials of Dallas, LP
Dallas Texas 75231 n/a

PRA Health Sciences
Salt Lake City Utah 84107 n/a

Independent Psychiatric Consultants
Waukesha Wisconsin 53188 n/a

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

Parkwood Institute
London Ontario N6C 0A7 n/a

Toronto Memory Program
Toronto Ontario M3B 2S7 n/a

Jewish General Hospital
Montreal Quebec H3T 1E2 n/a

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