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TRx0237 for Mild to Moderate 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 to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
N/A 89 Years Both No
December 2012
March 2015
833

  • Diagnosis of dementia and probable Alzheimer's disease
  • Clinical Dementia Rating (CDR) total score of 1 to 2; Mini-Mental State Examination (MMSE) score of 14-26 (inclusive); Modified Hachinski ischemic score of 4 or less
  • Women of childbearing potential must practice abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
  • Participant or his/her representative can read and understand the language of the study site
  • Caregiver who will provide written informed consent for his/her own participation; can read, understand, and speak the language of the study site; lives with the participant or sees him/her for at least 2 hours per day on 3 or more days per week; agrees to accompany the participant to each study visit; and can verify daily compliance with the study drug
  • If taking an Alzheimer's medication (acetylcholinesterase inhibitor and/or memantine), must have taken the medication for at least 3 months and be on stable dose

  • 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, epilepsy, significant head injury, or unexplained or recurrent loss of consciousness lasting 15 minutes or more
  • Major depressive disorder, schizophrenia, or other psychotic disorders; bipolar disorder; substance-related disorders
  • Metal implants in the head (except dental), pacemaker, cochlear implants, or any other nonremovable items that preclude MRI
  • Living in a hospital or moderate- to high-dependency continuous care facility
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Glucose-6-phosphate dehydrogenase deficiency
  • Current or past significant blood-related abnormality
  • Abnormal laboratory test results at screening as deemed by the investigator
  • Clinically significant cardiovascular disease or abnormal assessments
  • Pre-existing or current signs of respiratory failure
  • Concurrent 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 (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer), unless treatment has resulted in complete freedom from cancer for at least 2 years
  • Prior intolerance or hypersensitivity to methylthioninium-containing drug or similar organic dyes
  • Prohibited medications: Tacrine; anxiolytics and/or sedatives/hypnotics taken prior to cognitive testing (exceptions: sedation for imaging or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime); clozapine, olanzapine, carbamazepine, primidone, or drugs associated with methemoglobinemia
  • Current or recent participation in another clinical trial

In this study, researchers will test the drug TRx0237 (also called LMTX™) as a treatment for mild to moderate Alzheimer's disease. Results of cognitive testing and brain imaging will be compared between participants receiving one of two doses (125 mg/day or 250 mg/day) 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 its study sites, please contact Bernard Hall at 1-800-910-5609 or info@alzheimersstudies.net.

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

Feldman, Robert MD
Laguna Hills California 92653

University of Southern California
Los Angeles California 90033

Shankle Clinic and Hoag Memorial Hospital Presbyterian
Newport Beach California 92658

Pacific Research Network
San Diego California 92103

San Francisco Clinical Research Center
San Francisco California 94118

Yale University School of Medicine
New Haven Connecticut 06510

JEM Research
Atlantis Florida 33462

Brain Matters Research
Delray Beach Florida 33445

CNS Healthcare, Inc
Jacksonville Florida 32256

Compass Research, LLC-North Clinic
Leesburg Florida 34748

Miami Research Associates
Miami Florida 33143

Compass Research, LLC
Orlando Florida 32806

iResearch Atlanta
Decatur Georgia 30030

Alexian Brothers Neurosciences Institute
Elk Grove Illinois 60007

ActivMed Practices & Research
Methuen Massachusetts 01844

Olive Branch Family Medical
Olive Branch Mississippi 38654

Memory Enhancement Centers of America, Inc
Eatontown New Jersey 07724

CRI Worldwide
Marlton New Jersey 08053

The Cognitive Research Center of New Jersey
Springfield New Jersey 07801

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

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

SPRI
Brooklyn New York 11235

Neurobehavioral Clinical Research
Canton Ohio 44718

The Clinical Trial Center, LLC
Jenkintown Pennsylvania 19046

FutureSearch Trials of Neurology
Austin Texas 78731

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

TauRx Therapeutics Ltd.

Name Phone Email
Bernard Hall 1-800-910-5609 info@alzheimersstudies.net

NCT01689246

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease