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TRx0237 for Mild Alzheimer's

Recruiting

This Phase II/III study will test the safety and efficacy of the investigational drug TRx0237, also known as LMTX, in older adults with mild Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
N/A 90 Years All No
January 10, 2018
December 2022
375

  • Diagnosis of early Alzheimer's Disease, all probable AS and MCI due to AD.
  • Documented PET scan that is positive for amyloid
  • Mini-Mental State Examination score of 20 to 25 and Clinical Dementia Rating of 0.5
  • Global Clinical Dementia Rating (CDR) of 0.5
  • Females must be post-menopausal, be surgically sterile, have undergone bilateral tubal occlusion/ligation, or use adequate contraception
  • Able to read and understand in the language of the study site
  • Study partner who either lives with the participant or sufficient contact to provide assessment of changes over time, is fluent in the study site language, can attend study visits, and can verify the participant takes the study drug daily

  • Significant central nervous system disorder other than probable AD or MCI-AD
  • Significant intracranial focal or vascular pathology seen on magnetic resonance imaging (MRI) scan
  • Clinical evidence or history of cerebrovascular accident, transient ischemic attack (mini-stroke), significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment, or other unexplained or recurrent loss of consciousness for 15 minutes or more
  • Epilepsy
  • Major depressive disorder, schizophrenia and other psychotic disorders, bipolar disorder, and substance-related disorders, including alcohol
  • Non-removable items that could interfere with ability to undergo MRI, including metal implants in the head, pacemaker, and cochlear implants
  • Reside in hospital or moderate- to high-dependency continuous care facility
  • Any physical disability that would prevent completion of study procedures or assessments
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Glucose-6-phosphate dehydrogenase deficiency
  • History of or current significant blood abnormality
  • Abnormal serum chemistry laboratory value at screening
  • Clinically significant heart disease or abnormal assessments
  • Pre-existing or current signs of respiratory failure 
  • Significant immunologic, hepatobiliary, or endocrine disease and/or other unstable or major disease other than probable AD or MCI-AD
  • Diagnosis of cancer in past 2 years
  • Intolerance or hypersensitivity to methylthioninium-containing drugs or methemoglobinemia induced by such drugs, similar organic dyes, or any related components
  • Prohibited medications (within past 90 days): Souvenaid, clozapine, carbamazepine, primidone, valproate, or drugs for which there is a warning or precaution in the labeling about methemoglobinemia
  • Current or previous participation in another TRx0237 trial
  • Participation in a trial testing a drug, biologic, device, or medical food within 28 days prior to baseline or of a cognition-related product within 90 days prior to baseline unless part of the control group

TRx0237 is a small molecule drug being tested for its ability to inhibit aggregation of tau, a protein that forms neurofibrillary tangles in the brains of people with Alzheimer's and other neurodegenerative diseases. Participants in this study will be randomized to take either a 4 mg tablet of the study drug two times per day or placebo for 39 weeks. Researchers will measure changes in tau levels as seen on PET scans, as well as changes in brain atrophy (measured by MRI), cognitive function, and activities of daily living.

For more information about this study or study sites, contact Marcus Wischik at info@taurx.com.

Name City State Zip Status Primary Contact
Xenoscience
Phoenix Arizona 85004 Recruiting

Arizona Research Center
Phoenix Arizona 85053 Recruiting

Imaging Endpoints Research
Scottsdale Arizona 85258 Recruiting

Atria Clinical Research
Little Rock Arkansas 72209 Recruiting

CITrials
Bellflower California 90706 Not yet recruiting

ATP Clinical Research, Inc.
Costa Mesa California 92626 Active, not recruiting

HB Clinical Trials Inc.
Fountain Valley California 92708 Not yet recruiting

Fullerton Neurology and Headache Center
Fullerton California 92835 Terminated

Behavioral Research Specialist, LLC
Glendale California 91206 Active, not recruiting

Paradigm Research
La Mesa California 91942 Recruiting

Senior Clinical Trials, Inc.
Laguna Hills California 92653 Recruiting

Hoag Memorial Hospital Presbyterian
Newport Beach California 92663 Not yet recruiting

Excell Research, Inc.
Oceanside California 92056 Recruiting

Sutter Institute for Medical Research
Sacramento California 95816 Not yet recruiting

Sharp Mesa Vista Hospital
San Diego California 92123 Recruiting

CITrials
Santa Ana California 92705 Not yet recruiting

Syrentis Clinical Research
Santa Ana California 92705 Recruiting

California Neuroscience Medical Group
Sherman Oaks California 91403 Recruiting

Yale University
Fairfield Connecticut 06824 Not yet recruiting

Coastal Connecticut Research, LCC
New London Connecticut 06320 Not yet recruiting

Visionary Investigators Network
Aventura Florida 33180 Recruiting

Boca Raton Regional Hospital, Marcus Neuroscience Institute
Boca Raton Florida 33486 Not yet recruiting

Finlay Medical Research
Green Acres Florida 33467 Recruiting

MD Clinical
Hallandale Beach Florida 33009 Recruiting

Indago Research & Health Center, Inc.
Hialeah Florida 33012 Recruiting

Merrit Island Medical Research
Merritt Island Florida 32952 Recruiting

Health Care Family Rehab and Research
Miami Florida 33015 Recruiting

Homestead Associates in Research, Inc.
Miami Florida 33032 Not yet recruiting

Optimus Clinical Research
Miami Florida 33125 Recruiting

Biomed Research Institute, Inc
Miami Florida 33126 Recruiting

Finlay Medical Research
Miami Florida 33126 Recruiting

CCM Clinical Research Group
Miami Florida 33133 Recruiting

Advance Medical Research Center
Miami Florida 33135 Recruiting

Vitae Research Center, LLC
Miami Florida 33135 Recruiting

L&C Professional Medical Research Institute
Miami Florida 33144 Terminated

Allied Biomedical Research Institute
Miami Florida 33155 Recruiting

Future Care Solution, LLC
Miami Florida 33165 Recruiting

Florida International Research Center
Miami Florida 33173 Recruiting

Miami Dade Medical Research Institute, LLC
Miami Florida 33176 Recruiting

Visionary Investigators Network
Miami Florida 33176 Recruiting

Renstar Medical Research
Ocala Florida 34470 Not yet recruiting

Bioclinica Research
Ocala Florida 34471 Not yet recruiting

Sensible Healthcare
Ocoee Florida 34761 Recruiting

Bioclinica Research
Orlando Florida 32806 Recruiting

Combined Research Orlando Phase I-IV
Orlando Florida 32807 Not yet recruiting

IMIC Inc
Palmetto Bay Florida 33157 Recruiting

Emerald Coast Center for Neurological Disorders
Pensacola Florida 32504 Recruiting

Progressive Medical Research
Port Orange Florida 32127 Recruiting

The Roskamp Institute, Inc.
Sarasota Florida 34243 Recruiting

Meridien Research
Spring Hill Florida 34609 Withdrawn

Stedman Clinical Trials
Tampa Florida 33613 Recruiting

Alzheimer's Research and Treatment Center
Wellington Florida 33414 Recruiting

NeuroStudies.net, LLC
Decatur Georgia 30033 Active, not recruiting

Georgia Neurology and Sleep Medicine Associates
Suwanee Georgia 30024 Recruiting

Advanced Clinical Research
Boise Idaho 83642 Withdrawn

Josephson Wallack Munshower Neurology P.C.
Indianapolis Indiana 46256 Recruiting

Heartland Research Associates
Newton Kansas 67114 Withdrawn

Advanced Memory Research of NJ PC
Toms River New Jersey 08755 Recruiting

Neurology Specialists of Monmouth County, PA
West Long Branch New Jersey 07764 Not yet recruiting

Albany Medical College
Albany New York 12208 Not yet recruiting

SPRI Clinical Trials
Brooklyn New York 11235 Not yet recruiting

UBMD Neurology
Buffalo New York 14203 Recruiting

New York University
New York New York 10016 Not yet recruiting

Richmond Behavioral Associates
Staten Island New York 10312 Recruiting

Alzheimer's Memory Center
Charlotte North Carolina 28270 Recruiting

Wake Research Associates
Raleigh North Carolina 27612 Active, not recruiting

Neuroscience Research Center, LLC
Canton Ohio 44718 Recruiting

Valley Medical Research
Centerville Ohio 45459 Recruiting

The Lindner Research Center
Cincinnati Ohio 45219 Active, not recruiting

University of Cincinnati Neurology Department
Cincinnati Ohio 45219 Not yet recruiting

Neurology Diagnostics Inc.
Dayton Ohio 45459 Recruiting

Neuro-Behavioral Clinical Research, Inc.
North Canton Ohio 44321 Not yet recruiting

IPS Research Company
Oklahoma City Oklahoma 73106 Recruiting

Tulsa Clinical Research LLC
Tulsa Oklahoma 74136 Not yet recruiting

Neural Net Research
Portland Oregon 97225 Recruiting

CBRI - Roper Hospital
Charleston South Carolina 29414 Recruiting

Coastal Neurology
Port Royal South Carolina 29935 Recruiting

NIIP at Quillen College of Medicine
Johnson City Tennessee 37604 Not yet recruiting

Texas Neurology, P. A.
Dallas Texas 75214 Not yet recruiting

University of Texas Health Science Center
San Antonio Texas 78229 Not yet recruiting

Center for Alzheimer's Care, Imaging, and Research
Salt Lake City Utah 84108 Not yet recruiting

Re:Cognition Health
Fairfax Virginia 22031 Recruiting

Virginia Mason Medical Center
Seattle Washington 98101 Active, not recruiting

Kingfisher Cooperative, LLC
Spokane Washington 99202 Not yet recruiting

Universal Research Group, LLC
Tacoma Washington 98405 Not yet recruiting

Alpha Recherche Clinique
Québec G3K 2P8 Not yet recruiting

Okanagan Clinical Trials, Ltd.
Kelowna British Columbia V1Y 1Z9 Not yet recruiting

Medical Arts Health Research Group
West Vancouver British Columbia V7T 1C5 Not yet recruiting

True North Clinical Research - Halifax
Halifax Nova Scotia B3S 1M7 Not yet recruiting

True North Clinical Research
Kentville Nova Scotia B4N 4K9 Not yet recruiting

Memory Clinic (Ottawa)
Ottawa Ontario K1Z 1G3 Recruiting

Clinique Mémoire de l'Outaouais
Gatineau Quebec J8T 8J1 Recruiting

McGill University Faculty of Medicine - McGill Centre for Studies in Aging
Verdun Quebec H4H 1R3 Not yet recruiting

TauRx Therapeutics Ltd

Name Phone Email
Marcus Wischik +44 (0)1224 440935 info@taurx.com

NCT03446001

Randomized, Double-Blind, Placebo-Controlled, 2-Arm, 6-Month, Brain Imaging and Safety Study of TRx0237 in Subjects With Mild Alzheimer's Disease