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: 
Completed
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 CodePrimary Contact

Geolocation is 33.4528292, -112.0685027

Xenoscience, Inc/ 21st Century Neurology
Phoenix
Arizona
85004

Geolocation is 33.590277, -117.6962824

Feldman, Robert MD
Laguna Hills
California
92653

Geolocation is 34.0502898, -118.2117257

University of Southern California
Los Angeles
California
90033

Geolocation is 33.6391568, -117.8647939

Shankle Clinic and Hoag Memorial Hospital Presbyterian
Newport Beach
California
92658

Geolocation is 32.749789, -117.1676501

Pacific Research Network
San Diego
California
92103

Geolocation is 37.7822891, -122.463708

San Francisco Clinical Research Center
San Francisco
California
94118

Geolocation is 41.3052226, -72.9268626

Yale University School of Medicine
New Haven
Connecticut
06510

Geolocation is 26.5909025, -80.1008762

JEM Research
Atlantis
Florida
33462

Geolocation is 26.4647478, -80.109357

Brain Matters Research
Delray Beach
Florida
33445

Geolocation is 30.2205397, -81.5537192

CNS Healthcare, Inc
Jacksonville
Florida
32256

Geolocation is 28.810823, -81.8778582

Compass Research, LLC-North Clinic
Leesburg
Florida
34748

Geolocation is 25.6993807, -80.2934522

Miami Research Associates
Miami
Florida
33143

Geolocation is 28.5085825, -81.3564411

Compass Research, LLC
Orlando
Florida
32806

Geolocation is 33.7748275, -84.2963123

iResearch Atlanta
Decatur
Georgia
30030

Geolocation is 42.0039178, -87.9703461

Alexian Brothers Neurosciences Institute
Elk Grove
Illinois
60007

Geolocation is 42.7262016, -71.1908924

ActivMed Practices & Research
Methuen
Massachusetts
01844

Geolocation is 34.9617604, -89.8295315

Olive Branch Family Medical
Olive Branch
Mississippi
38654

Geolocation is 40.2962222, -74.0509725

Memory Enhancement Centers of America, Inc
Eatontown
New Jersey
07724

Geolocation is 39.8912248, -74.9218324

CRI Worldwide
Marlton
New Jersey
08053

Geolocation is 40.740169, -74.167076

The Cognitive Research Center of New Jersey
Springfield
New Jersey
07801

Geolocation is 39.9618663, -74.2583556

Advanced Memory Research Institute of NJ PC
Toms River
New Jersey
08757

Geolocation is 42.6547387, -73.7889689

Neurological Associates of Albany, P. C.
Albany
New York
12208

Geolocation is 40.5860069, -73.9418603

SPRI
Brooklyn
New York
11235

Geolocation is 40.8540649, -81.460856

Neurobehavioral Clinical Research
Canton
Ohio
44718

Geolocation is 40.0959438, -75.1251743

The Clinical Trial Center, LLC
Jenkintown
Pennsylvania
19046

Geolocation is 30.3542409, -97.7742702

FutureSearch Trials of Neurology
Austin
Texas
78731

Geolocation is 49.8900709, -119.4931005

Okanagan Clinical Trials
Kelowna
British Columbia
V1Y 1Z9

Geolocation is 45.0836805, -64.497142

True North Clinical Research Kentville Inc
Kentville
Nova Scotia
B4N 4K9

Geolocation is 43.7585342, -79.3535081

Toronto Memory Program
North York
Ontario
M3B 2S7
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