Alzheimer's Disease Education and Referral Center

TRx0237 for Mild Alzheimer's Disease

TRx0237 for Mild 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 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 CodePrimary Contact

Geolocation is 33.4528292, -112.0685027

Xenoscience, Inc / 21st Century Neurology
Phoenix
Arizona
85004
n/a

Geolocation is 33.6364503, -112.0118669

NoesisPharma Clinical Trials
Phoenix
Arizona
85032
n/a

Geolocation is 33.8816818, -118.1170117

CITrials
Bellflower
California
90706
n/a

Geolocation is 33.6834142, -117.9073244

ATP Clinical Research, Inc.
Costa Mesa
California
92626
n/a

Geolocation is 33.7091847, -117.9536697

Southern California Research, LLC
Fountain Valley
California
92708
n/a

Geolocation is 33.590277, -117.6962824

Feldman, Robert MD
Laguna Hills
California
92653
n/a

Geolocation is 32.7425516, -117.0314172

Synergy East
Lemon Grove
California
91945
n/a

Geolocation is 33.8065036, -118.1912538

Collaborative Neuroscience Network
Long Beach
California
90806
n/a

Geolocation is 34.1406082, -118.1678543

Neuro-Therapeutics, Inc.
Pasadena
California
91105
n/a

Geolocation is 34.0708773, -117.1558867

Anderson Clinical Research
Redlands
California
92374
n/a

Geolocation is 32.749789, -117.1676501

Pacific Research Network
San Diego
California
92103
n/a

Geolocation is 37.7822891, -122.463708

San Francisco Clinical Research Center
San Francisco
California
94118
n/a

Geolocation is 34.02875, -118.4717975

Neurological Research Institute
Santa Monica
California
90404
n/a

Geolocation is 34.1423899, -118.4571974

Schuster Medical Research Institute
Sherman Oaks
California
91403
n/a

Geolocation is 39.732746, -104.9710123

Mile High Research Center
Denver
Colorado
80218
n/a

Geolocation is 41.3052226, -72.9268626

Institute for Neurodegenerative Disorders
New Haven
Connecticut
06510
n/a

Geolocation is 41.3631426, -72.106068

Coastal Connecticut Research, LLC
New London
Connecticut
06320
n/a

Geolocation is 41.1339818, -73.4062342

Research Center for Clinical Studies, Inc
Norwalk
Connecticut
06851
n/a

Geolocation is 26.5909025, -80.1008762

JEM Research
Atlantis
Florida
33462
n/a

Geolocation is 27.4872771, -82.5889012

Bradenton Research Center
Bradenton
Florida
34205
n/a

Geolocation is 28.5552719, -82.3878709

Meridien Research
Brooksville
Florida
34601
n/a

Geolocation is 26.4647478, -80.109357

Brain Matters Research
Delray Beach
Florida
33445
n/a

Geolocation is 25.9812024, -80.148379

MD Clinical
Hallandale Beach
Florida
33009
n/a

Geolocation is 26.5907805, -80.2432839

Alzheimer's Research and Treatment Center
Lake Worth
Florida
33449
n/a

Geolocation is 28.5085825, -81.3564411

Compass Research, LLC
Orlando
Florida
32806
n/a

Geolocation is 27.4081935, -82.5294065

The Roskamp Institute, Inc.
Sarasota
Florida
34243
n/a

Geolocation is 27.9407591, -82.5104655

Axiom Clinical Research of Florida
Tampa
Florida
33609
n/a

Geolocation is 28.0869646, -82.4698603

USF Health Byrd Alzheimer's Institute
Tampa
Florida
33613
n/a

Geolocation is 28.9121162, -81.986206

Compass Research, LLC - North Clinic
The Villages
Florida
32162
n/a

Geolocation is 26.7619563, -80.1037721

Premiere Research Institute (Palm Beach Neurology)
West Palm Beach
Florida
33407
n/a

Geolocation is 33.698565, -84.5431867

Atlanta Center for Medical Research
Atlanta
Georgia
30331
n/a

Geolocation is 33.8092255, -84.2805478

Neurostudies.net
Decatur
Georgia
30033
n/a

Geolocation is 42.0039178, -87.9703461

Alexian Brothers Neurosciences Institute
Elk Grove
Illinois
60007
n/a

Geolocation is 41.608982, -93.6268464

Ruan Neurology Clinic and Research Center
Des Moines
Iowa
50314
n/a

Geolocation is 39.0839973, -77.1527578

CBH Health, LLC
Rockville
Maryland
20850
n/a

Geolocation is 42.5049385, -83.3468784

Quest Research Institute
Farmington Hills
Michigan
48334
n/a

Geolocation is 31.3271189, -89.2903392

Neurological Research Center - Hattiesburg Clinic
Hattiesburg
Mississippi
39401
n/a

Geolocation is 34.9617604, -89.8295315

Olive Branch Family Medical
Olive Branch
Mississippi
38654
n/a

Geolocation is 38.6608855, -90.422618

Millennium Psychiatric Associates
Creve Coeur
Missouri
63141
n/a

Geolocation is 40.2962222, -74.0509725

Memory Enhancement Centers of America, Inc
Eatontown
New Jersey
07724
n/a

Geolocation is 39.9618663, -74.2583556

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

Geolocation is 35.1590068, -106.5760857

Albuquerque Neuroscience
Albuquerque
New Mexico
87109
n/a

Geolocation is 42.6547387, -73.7889689

Neurological Associates of Albany, P. C.
Albany
New York
12208
n/a

Geolocation is 41.0550969, -73.8201337

MedicalPsych Care, PLLC
Elmsford
New York
10523
n/a

Geolocation is 40.8409822, -73.9447994

Columbia University Taub Institute
New York
New York
10032
n/a

Geolocation is 41.0464858, -73.9495818

Research Foundation for Mental Hygiene, Inc.
Orangeburg
New York
10962
n/a

Geolocation is 35.8533273, -78.6965972

Wake Research Associates
Raleigh
North Carolina
27612
n/a

Geolocation is 36.0564654, -80.3324514

Clinical Trials of America, Inc
Winston-Salem
North Carolina
27103
n/a

Geolocation is 40.8540649, -81.460856

Neurobehavorial Clinical Research
Canton
Ohio
44718
n/a

Geolocation is 35.5135639, -97.5788975

Oklahoma Clinical Research Center
Oklahoma City
Oklahoma
73112
n/a

Geolocation is 40.0959438, -75.1251743

The Clinical Trial Center, LLC
Jenkintown
Pennsylvania
19046
n/a

Geolocation is 41.816736, -71.4091563

RI Hospital
Providence
Rhode Island
02903
n/a

Geolocation is 35.1376546, -89.7661527

Neurology Clinic, P.C.
Cordova
Tennessee
38018
n/a

Geolocation is 35.0772572, -89.84582

Clinical Neuroscience Solutions CNS Healthcare
Memphis
Tennessee
38119
n/a

Geolocation is 30.3568213, -97.730807

Senior Adults Specialty Research, Inc.
Austin
Texas
78757
n/a

Geolocation is 32.8798071, -96.7547522

FutureSearch Trials of Dallas, LP
Dallas
Texas
75231
n/a

Geolocation is 40.6620696, -111.8866683

PRA Health Sciences
Salt Lake City
Utah
84107
n/a

Geolocation is 43.0116784, -88.2314813

Independent Psychiatric Consultants
Waukesha
Wisconsin
53188
n/a

Geolocation is 49.2601955, -123.2426367

University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver
British Columbia
V6T 1Z3
n/a

Geolocation is 42.9598744, -81.2353612

Parkwood Institute
London
Ontario
N6C 0A7
n/a

Geolocation is 43.7585342, -79.3535081

Toronto Memory Program
Toronto
Ontario
M3B 2S7
n/a

Geolocation is 45.4976084, -73.6292768

Jewish General Hospital
Montreal
Quebec
H3T 1E2
n/a
Lead Sponsor: 
Agency
TauRx Therapeutics Ltd.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
Kim Lee
1-800-910-5609
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