Alzheimer's Disease Education and Referral Center

TRx0237 for Mild Alzheimer's Disease

TRx0237 for Mild Alzheimer's Disease

Overall Status: 
Active, not 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 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
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 Karen Pozzie at 1-800-910-5609 or info@alzheimersstudies.net.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.6364503, -112.0118669

Site
Phoenix
Arizona
85032
Name:
Phone:

Geolocation is 33.4528292, -112.0685027

Site
Phoenix
Arizona
85004
Name:
Phone:

Geolocation is 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Name:
Phone:

Geolocation is 33.9372725, -118.1298234

Site
Downey
California
90241
Name:
Phone:

Geolocation is 33.090285, -117.0499859

Site
Escondido
California
92025
Name:
Phone:

Geolocation is 33.7091847, -117.9536697

Site
Fountain Valley
California
92708
Name:
Phone:

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
92653
Name:
Phone:

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Name:
Phone:

Geolocation is 34.1406082, -118.1678543

Site
Pasadena
California
91105
Name:
Phone:

Geolocation is 34.0708773, -117.1558867

Site
Redlands
California
92374
Name:
Phone:

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Name:
Phone:

Geolocation is 37.7822891, -122.463708

Site
San Francisco
California
94118
Name:
Phone:

Geolocation is 34.02875, -118.4717975

Site
Santa Monica
California
90404
Name:
Phone:

Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Name:
Phone:

Geolocation is 39.732746, -104.9710123

Site
Denver
Colorado
80218
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Name:
Phone:

Geolocation is 41.3631426, -72.106068

Site
New London
Connecticut
06320
Name:
Phone:

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Name:
Phone:

Geolocation is 26.5909025, -80.1008762

Site
Atlantis
Florida
33462
Name:
Phone:

Geolocation is 27.4872771, -82.5889012

Site
Bradenton
Florida
34205
Name:
Phone:

Geolocation is 28.5552719, -82.3878709

Site
Brooksville
Florida
34601
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Name:
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Name:
Phone:

Geolocation is 26.5907805, -80.2432839

Site
Lake Worth
Florida
33449
Name:
Phone:

Geolocation is 28.810823, -81.8778582

Site
Leesburg
Florida
34748
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Name:
Phone:

Geolocation is 27.4081935, -82.5294065

Site
Sarasota
Florida
34243
Name:
Phone:

Geolocation is 27.9407591, -82.5104655

Site
Tampa
Florida
33609
Name:
Phone:

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Name:
Phone:

Geolocation is 33.7717008, -84.3726049

Site
Atlanta
Georgia
30308
Name:
Phone:

Geolocation is 33.8092255, -84.2805478

Site
Decatur
Georgia
30033
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove
Illinois
60007
Name:
Phone:

Geolocation is 41.608982, -93.6268464

Site
Des Moines
Iowa
50314
Name:
Phone:

Geolocation is 39.0839973, -77.1527578

Site
Rockville
Maryland
20850
Name:
Phone:

Geolocation is 42.5049385, -83.3468784

Site
Farmington Hills
Michigan
48334
Name:
Phone:

Geolocation is 31.3271189, -89.2903392

Site
Hattiesburg
Mississippi
39401
Name:
Phone:

Geolocation is 34.9617604, -89.8295315

Site
Olive Branch
Mississippi
38654
Name:
Phone:

Geolocation is 38.6608855, -90.422618

Site
Creve Coeur
Missouri
63141
Name:
Phone:

Geolocation is 40.2962222, -74.0509725

Site
Eatontown
New Jersey
07724
Name:
Phone:

Geolocation is 39.9471038, -74.2531465

Site
Toms River
New Jersey
08757
Name:
Phone:

Geolocation is 35.1590068, -106.5760857

Site
Albuquerque
New Mexico
87109
Name:
Phone:

Geolocation is 42.6547387, -73.7889689

Site
Albany
New York
12208
Name:
Phone:

Geolocation is 41.0550969, -73.8201337

Site
Elmsford
New York
10523
Name:
Phone:

Geolocation is 40.8409822, -73.9447994

Site
New York
New York
10032
Name:
Phone:

Geolocation is 41.0464858, -73.9495818

Site
Orangeburg
New York
10962
Name:
Phone:

Geolocation is 35.8533273, -78.6965972

Site
Raleigh
North Carolina
27612
Name:
Phone:

Geolocation is 36.0564654, -80.3324514

Site
Winston-Salem
North Carolina
27103
Name:
Phone:

Geolocation is 40.8540649, -81.460856

Site
Canton
Ohio
44718
Name:
Phone:

Geolocation is 35.5135639, -97.5788975

Site
Oklahoma City
Oklahoma
73112
Name:
Phone:

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
19046
Name:
Phone:

Geolocation is 41.816736, -71.4091563

Site
Providence
Rhode Island
02903
Name:
Phone:

Geolocation is 35.1376546, -89.7661527

Site
Cordova
Tennessee
38018
Name:
Phone:

Geolocation is 35.0772572, -89.84582

Site
Memphis
Tennessee
38119
Name:
Phone:

Geolocation is 30.3568213, -97.730807

Site
Austin
Texas
78757
Name:
Phone:

Geolocation is 32.8798071, -96.7547522

Site
Dallas
Texas
75231
Name:
Phone:

Geolocation is 40.7078639, -111.8508966

Site
Salt Lake City
Utah
84106
Name:
Phone:

Geolocation is 43.0165459, -88.2947675

Site
Waukesha
Wisconsin
53188
Name:
Phone:

Geolocation is 49.2650543, -123.2459921

Site
Vancouver
British Columbia
V6T 2B5
Name:
Phone:

Geolocation is 42.9555117, -81.2257216

Site
London
Ontario
N6C 5J1
Name:
Phone:

Geolocation is 43.7585342, -79.3535081

Site
Toronto
Ontario
M3B 2S7
Name:
Phone:

Geolocation is 45.4976084, -73.6292768

Site
Montreal
Quebec
H3T 1E2
Name:
Phone:
Lead Sponsor: 
Agency
TauRx Therapeutics Ltd.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
Kim Lee
1-800-910-5609
Locations
 
 
ClinicalTrials.gov ID 
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