Alzheimer's Disease Education and Referral Center

TRx0237 for Mild to Moderate Alzheimer's Disease

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

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

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.

Central Contact Information: 

For more information about this trial or its study sites, please contact Bernard Hall at 1-800-910-5609 or info@alzheimersstudies.net.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4483771, -112.0740373

Site
Phoenix
Arizona
Not yet recruiting
Name:
Phone:

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
Recruiting
Name:
Phone:

Geolocation is 34.0522342, -118.2436849

Site
Los Angeles
California
Recruiting
Name:
Phone:

Geolocation is 33.6189101, -117.9289469

Site
Newport Beach
California
Not yet recruiting
Name:
Phone:

Geolocation is 32.7153292, -117.1572551

Site
San Diego
California
Not yet recruiting
Name:
Phone:

Geolocation is 37.7749295, -122.4194155

Site
San Francisco
California
Not yet recruiting
Name:
Phone:

Geolocation is 41.308274, -72.9278835

Site
New Haven
Connecticut
Recruiting
Name:
Phone:

Geolocation is 26.5909025, -80.1008762

Site
Atlantis
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 26.4614625, -80.0728201

Site
Delray Beach
Florida
Recruiting
Name:
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 30.3321838, -81.655651

Site
Jacksonville
Florida
Recruiting
Name:
Phone:

Geolocation is 28.810823, -81.8778582

Site
Leesburg
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 25.7889689, -80.2264393

Site
Miami
Florida
Recruiting
Name:
Phone:

Geolocation is 28.5383355, -81.3792365

Site
Orlando
Florida
Not yet recruiting
Name:
Phone:

Geolocation is 33.7748275, -84.2963123

Site
Decatur
Georgia
Recruiting
Name:
Phone:

Geolocation is 42.0408898, -87.9922684

Site
Elk Grove
Illinois
Not yet recruiting
Name:
Phone:

Geolocation is 42.7262016, -71.1908924

Site
Methuen
Massachusetts
Recruiting
Name:
Phone:

Geolocation is 42.3370413, -71.2092214

Site
Newton
Massachusetts
Not yet recruiting
Name:
Phone:

Geolocation is 34.9617604, -89.8295315

Site
Olive Branch
Mississippi
Not yet recruiting
Name:
Phone:

Geolocation is 40.2962222, -74.0509725

Site
Eatontown
New Jersey
Recruiting
Name:
Phone:

Geolocation is 39.8912248, -74.9218324

Site
Marlton
New Jersey
Recruiting
Name:
Phone:

Geolocation is 40.716111, -74.3625

Site
Summit
New Jersey
Recruiting
Name:
Phone:

Geolocation is 39.9537358, -74.1979458

Site
Toms River
New Jersey
Recruiting
Name:
Phone:

Geolocation is 42.6525793, -73.7562317

Site
Albany
New York
Recruiting
Name:
Phone:

Geolocation is 40.65, -73.95

Site
Brooklyn
New York
Recruiting
Name:
Phone:

Geolocation is 40.7989473, -81.378447

Site
Canton
Ohio
Not yet recruiting
Name:
Phone:

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
Recruiting
Name:
Phone:

Geolocation is 30.267153, -97.7430608

Site
Austin
Texas
Recruiting
Name:
Phone:

Geolocation is 49.8879519, -119.4960106

Site
Kelowna
British Columbia
Recruiting
Name:
Phone:

Geolocation is 45.0769115, -64.4944735

Site
Kentville
Nova Scotia
Recruiting
Name:
Phone:

Geolocation is 43.7615377, -79.4110794

Site
North York
Ontario
Recruiting
Name:
Phone:

Geolocation is 45.5086699, -73.5539925

Site
Montreal
Quebec
Not yet recruiting
Name:
Phone:
Lead Sponsor: 
Agency
TauRx Therapeutics Ltd.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
Bernard Hall
1-800-910-5609
Locations
 
 
ClinicalTrials.gov ID 
NCT01689246 (follow link to view full record on ct.gov in new window)
Official Title: 
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Study Start Date: 
December 2012
Study End Date: 
March 2015
Disease Stage: 
Early
Middle
Enrollment: 
833