Alzheimer's Disease Education and Referral Center

TRx0237 for Mild Alzheimer's Disease

TRx0237 for Mild Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
N/A
89 Years
Both
No
Inclusion Criteria: 

    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
Exclusion Criteria: 
    • 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 associated with methemoglobinemia
    • Current or prior participation in a Phase III clinical trial of a product for cognition within the past 3 months (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
Detailed Description: 

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.

Central Contact Information: 

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

Locations: 
Map MarkerCityStateStatusPrimary Contact

Geolocation is 33.4483771, -112.0740373

Phoenix
Arizona
Recruiting
Name:
Phone:

Geolocation is 33.1192068, -117.086421

Escondido
California
Recruiting
Name:
Phone:

Geolocation is 33.7091847, -117.9536697

Fountain Valley
California
Recruiting
Name:
Phone:

Geolocation is 33.768321, -118.1956168

Long Beach
California
Recruiting
Name:
Phone:

Geolocation is 40.5865396, -122.3916754

Redding
California
Not yet recruiting
Name:
Phone:

Geolocation is 32.7153292, -117.1572551

San Diego
California
Recruiting
Name:
Phone:

Geolocation is 37.7749295, -122.4194155

San Francisco
California
Recruiting
Name:
Phone:

Geolocation is 34.0194543, -118.4911912

Santa Monica
California
Recruiting
Name:
Phone:

Geolocation is 34.1489719, -118.451357

Sherman Oaks
California
Recruiting
Name:
Phone:

Geolocation is 39.737567, -104.9847179

Denver
Colorado
Recruiting
Name:
Phone:

Geolocation is 26.5909025, -80.1008762

Atlantis
Florida
Recruiting
Name:
Phone:

Geolocation is 27.4989278, -82.5748194

Bradenton
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 28.5552719, -82.3878709

Brooksville
Florida
Recruiting
Name:
Phone:

Geolocation is 25.9812024, -80.148379

Hallandale Beach
Florida
Recruiting
Name:
Phone:

Geolocation is 26.6159015, -80.056986

Lake Worth
Florida
Recruiting
Name:
Phone:

Geolocation is 28.810823, -81.8778582

Leesburg
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 26.1723065, -80.1319893

Oakland Park
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 28.5383355, -81.3792365

Orlando
Florida
Recruiting
Name:
Phone:

Geolocation is 26.7153424, -80.0533746

West Palm Beach
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 33.7489954, -84.3879824

Atlanta
Georgia
Recruiting
Name:
Phone:

Geolocation is 42.0408898, -87.9922684

Elk Grove
Illinois
Recruiting
Name:
Phone:

Geolocation is 41.6005448, -93.6091064

Des Moines
Iowa
Not yet recruiting
Name:
Phone:

Geolocation is 39.0839973, -77.1527578

Rockville
Maryland
Not yet recruiting
Name:
Phone:

Geolocation is 42.3370413, -71.2092214

Newton
Massachusetts
Recruiting
Name:
Phone:

Geolocation is 34.9617604, -89.8295315

Olive Branch
Mississippi
Recruiting
Name:
Phone:

Geolocation is 40.2962222, -74.0509725

Eatontown
New Jersey
Not yet recruiting
Name:
Phone:

Geolocation is 40.336419, -74.4330474

Monroe Township
New Jersey
Recruiting
Name:
Phone:

Geolocation is 39.9537358, -74.1979458

Toms River
New Jersey
Not yet recruiting
Name:
Phone:

Geolocation is 35.110703, -106.609991

Albuquerque
New Mexico
Not yet recruiting
Name:
Phone:

Geolocation is 42.6525793, -73.7562317

Albany
New York
Not yet recruiting
Name:
Phone:

Geolocation is 41.0464858, -73.9495818

Orangeburg
New York
Not yet recruiting
Name:
Phone:

Geolocation is 40.5795317, -74.1502007

Staten Island
New York
Recruiting
Name:
Phone:

Geolocation is 40.7989473, -81.378447

Canton
Ohio
Recruiting
Name:
Phone:

Geolocation is 35.4675602, -97.5164276

Oklahoma City
Oklahoma
Recruiting
Name:
Phone:

Geolocation is 35.9250637, -86.8688899

Franklin
Tennessee
Recruiting
Name:
Phone:

Geolocation is 35.1495343, -90.0489801

Memphis
Tennessee
Recruiting
Name:
Phone:

Geolocation is 32.7801399, -96.8004511

Dallas
Texas
Not yet recruiting
Name:
Phone:

Geolocation is 40.7607793, -111.8910474

Salt Lake City
Utah
Recruiting
Name:
Phone:

Geolocation is 49.261226, -123.1139268

Vancouver
British Columbia
Not yet recruiting
Name:
Phone:

Geolocation is 45.5086699, -73.5539925

Montreal
Quebec
Not yet recruiting
Name:
Phone:
Lead Sponsor: 
Agency
TauRx Therapeutics Ltd.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
Kim Lee
1-800-910-5609
info@alzheimersstudies.net
Locations
 
 
ClinicalTrials.gov ID 
NCT01689233 (follow link to view full record on ct.gov in new window)
Official Title: 
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease
Study Start Date: 
November 2012
Study End Date: 
July 2015
Disease Stage: 
Early
Enrollment: 
500