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: 
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 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 33.4528292, -112.0685027

Site
Phoenix
Arizona
85004
Name:
Phone:

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
92653
Name:
Phone:

Geolocation is 34.0502898, -118.2117257

Site
Los Angeles
California
90033
Name:
Phone:

Geolocation is 33.6392245, -117.8647782

Site
Newport Beach
California
92658
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 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Name:
Phone:

Geolocation is 26.5909025, -80.1008762

Site
Atlantis
Florida
33462
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 30.2205397, -81.5537192

Site
Jacksonville
Florida
32256
Name:
Phone:

Geolocation is 28.810823, -81.8778582

Site
Leesburg
Florida
34748
Name:
Phone:

Geolocation is 25.6993807, -80.2934522

Site
Miami
Florida
33143
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Name:
Phone:

Geolocation is 33.7748275, -84.2963123

Site
Decatur
Georgia
30030
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove
Illinois
60007
Name:
Phone:

Geolocation is 42.7262016, -71.1908924

Site
Methuen
Massachusetts
01844
Name:
Phone:

Geolocation is 42.3028239, -71.1864397

Site
Newton
Massachusetts
02459
Name:
Phone:

Geolocation is 34.9617604, -89.8295315

Site
Olive Branch
Mississippi
38654
Name:
Phone:

Geolocation is 40.2962222, -74.0509725

Site
Eatontown
New Jersey
07724
Name:
Phone:

Geolocation is 39.8912248, -74.9218324

Site
Marlton
New Jersey
08053
Name:
Phone:

Geolocation is 40.7385033, -74.1903104

Site
Springfield
New Jersey
07801
Name:
Phone:

Geolocation is 39.9471038, -74.2531465

Site
Toms River
New Jersey
08757
Name:
Phone:

Geolocation is 42.6547387, -73.7889689

Site
Albany
New York
12208
Name:
Phone:

Geolocation is 40.5860069, -73.9418603

Site
Brooklyn
New York
11235
Name:
Phone:

Geolocation is 40.8540649, -81.460856

Site
Canton
Ohio
44718
Name:
Phone:

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
19046
Name:
Phone:

Geolocation is 30.3542409, -97.7742702

Site
Austin
Texas
78731
Name:
Phone:

Geolocation is 49.8900709, -119.4931005

Site
Kelowna
British Columbia
V1Y 1Z9
Name:
Phone:

Geolocation is 45.0836805, -64.497142

Site
Kentville
Nova Scotia
B4N 4K9
Name:
Phone:

Geolocation is 43.7585342, -79.3535081

Site
North York
Ontario
M3B 2S7
Name:
Phone:

Geolocation is 45.4420201, -73.5800493

Site
Montreal
Quebec
H4H 1R3
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 
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