Alzheimer's Disease Education and Referral Center

TRx0237 to Treat Behavioral Variant Frontotemporal Dementia

TRx0237 to Treat Behavioral Variant Frontotemporal Dementia

Overall Status: 
Completed
Brief Description: 

The purpose of this study is to test the experimental drug TRx0237 as a treatment for behavioral variant frontotemporal dementia (bvFTD).

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
N/A
79 Years
Both
No
Inclusion Criteria: 
    • Diagnosis of probable behavioral variant frontotemporal dementia (bvFTD)
    • Centrally rated frontotemporal atrophy score of 2 or greater on brain MRI; Mini-Mental State Examination score of 20 or less; modified Hachinski ischemic score of 4 or less
    • Females, if of child-bearing potential, must practice abstinence or be competent to use adequate contraception throughout the study
    • Adult caregiver who is willing to provide written informed consent for his/her own participation; can read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for at least 2 hours/day on 3 or more days/week; agrees to accompany the participant to each study visit; and is able to verify daily compliance with the study drug
    • If currently taking an acetylcholinesterase inhibitor and/or memantine, taking the drug for at least 3 months and on a stable dose for at least 6 weeks
Exclusion Criteria: 
    • Significant central nervous system (CNS) disorder other than bvFTD; significant focal or vascular intracranial pathology seen on brain MRI scan
    • Biomarker evidence of underlying Alzheimer's disease pathology
    • Expressive language deficits
    • Meets research criteria for amyotrophic lateral sclerosis or motor neuron disease
    • Meets diagnostic criteria for probable bvFTD but has a proven mutation-producing, non-tau, non-TDP-43 pathology
    • Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness for at least 15 minutes
    • Epilepsy
    • Rapid eye movement sleep behavior disorder
    • Major depressive disorder, schizophrenia, or other psychotic disorders; bipolar disorder; substance (including alcohol)-related disorders
    • Metal implants in the head (except dental), pacemaker, cochlear implants, or any other nonremovable items that prevent MRI
    • Resides in a hospital or moderate- to high-dependency care facility
    • History of swallowing difficulties
    • Pregnant or breastfeeding
    • Glucose-6-phosphate dehydrogenase deficiency
    • History of significant hematological abnormality; clinically significant cardiovascular disease or abnormal assessments; preexisting or current signs or symptoms of respiratory failure
    • Concurrent clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than bvFTD
    • 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 drug substances
    • Prohibited medications (current or past 90 days): tacrine, amphetamine, dexamphetamine, clozapine, olanzapine, carbamazepine, primidone, or drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses
    • Participation in a clinical trial of a product for cognition within the past 3 months; of a drug, biologic, device, or medical food in which the last dose/administration was received within the past 28 days
Detailed Description: 

This Phase III international trial will test the drug TRx0237 (also known as LMTXTM) as a possible treatment for bvFTD. Participants will take either a 100-mg tablet of the study drug or a placebo twice daily for 1 year and undergo cognitive testing. TRx0237 works by inhibiting the action of tau, a protein that accumulates abnormally in the brains of people with bvFTD.

Central Contact Information: 

For more information about this clinical trial or study sites, please contact Karen Pozzie at 1-800-910-5609 or info@alzheimersstudies.net.

Locations: 
Map Marker CityStateZip CodePrimary Contact

Geolocation is 34.070264, -118.4440562

David Geffen School of Medicine at UCLA, UCLA Neurological Services
Los Angeles
California
90095

Geolocation is 33.615828, -117.9307584

The Shankle Clinic
Newport Beach
California
92663

Geolocation is 37.7748363, -122.3872576

Memory and Aging Centre
San Francisco
California
94158

Geolocation is 28.5552719, -82.3878709

Meridien Research
Brooksville
Florida
34601

Geolocation is 30.2606613, -81.460856

Mayo Clinic
Jacksonville
Florida
32224

Geolocation is 28.5085825, -81.3564411

Compass Research, LLC
Orlando
Florida
32806

Geolocation is 28.0869646, -82.4698603

University of South Florida
Tampa
Florida
33613

Geolocation is 33.828105, -84.3279093

Department of Neurology, Emory University
Atlanta
Georgia
30329

Geolocation is 42.0039178, -87.9703461

Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village
Illinois
60007

Geolocation is 39.7794767, -86.1700894

Indiana University Department of Neurology
Indianapolis
Indiana
46202

Geolocation is 39.2713976, -76.5603828

Johns Hopkins University
Baltimore
Maryland
21224

Geolocation is 42.3652917, -71.0646337

Neurological Clinical Research Institute (NCRI) Massachusetts General Hospital
Boston
Massachusetts
02114

Geolocation is 44.0557303, -92.5253639

Mayo Clinic, Department of Neurology
Rochester
Minnesota
55905

Geolocation is 40.2962222, -74.0509725

Memory Enhancement Center of America, Inc.
Eatontown
New Jersey
07724

Geolocation is 42.6547387, -73.7889689

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

Geolocation is 40.5988077, -73.9447994

Integrative Clinical Trials LLC
Brooklyn
New York
11229

Geolocation is 35.905249, -79.0581498

UNC Department of Neurology, Physicians Office Building
Chapel Hill
North Carolina
27599

Geolocation is 41.5091257, -81.6089873

University Hospitals Case Medical Center, Neurology Clinical Trials Unit
Cleveland
Ohio
44106

Geolocation is 35.5135639, -97.5788975

Rivers Wellness and Research Institute
Oklahoma City
Oklahoma
73112

Geolocation is 40.0959438, -75.1251743

The Clinical Trial Center, LLC
Jenkintown
Pennsylvania
19046

Geolocation is 39.9583587, -75.1953934

Hospital of the University of Pennsylvania, Department of Neurology
Philadelphia
Pennsylvania
19104

Geolocation is 40.7078639, -111.8508966

PRA Health Sciences, Phase 2/3 Outpatient and CNS Clinic
Salt Lake City
Utah
84106

Geolocation is 42.8781345, -73.1967741

The Memory Clinic
Bennington
Vermont
05201

Geolocation is 38.0293059, -78.4766781

University of Virginia
Charlottesville
Virginia
22903

Geolocation is 51.0662767, -114.1355032

Heritage Medical Research Clinic-University of Calgary
Calgary
Alberta
T2N 4Z6

Geolocation is 49.2650543, -123.2459921

University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver
British Columbia
V6T 2B5

Geolocation is 48.4314591, -123.3274789

Vancouver Island Health Authority
Victoria
British Columbia
V8R 1J8

Geolocation is 44.6582865, -63.6700901

True North Clinical Research
Halifax
Nova Scotia
B3S 1M7

Geolocation is 42.9598744, -81.2353612

Geriatric Clinical Trials Group, Parkwood Institute
London
Ontario
N6C 0A7

Geolocation is 43.7585342, -79.3535081

Toronto Memory Program
Toronto
Ontario
M3B 2S7

Geolocation is 43.6534023, -79.4053266

University Health Network, Toronto Western Hospital, Memory Clinic
Toronto
Ontario
M5T 2S8

Geolocation is 45.4420201, -73.5800493

McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
Verdun
Quebec
H4H 1R3
Lead Sponsor: 
Agency
TauRx Therapeutics Ltd.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
Bernard Hall
1-800-910-5609
Locations
 
 
ClinicalTrials.gov ID 
NCT01626378 (follow link to view full record on ct.gov in new window)
Official Title: 
A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)
Study Start Date: 
August 2013
Study End Date: 
August 2015
Enrollment: 
180