Alzheimer's Disease Education and Referral Center

TRx0237 to Treat Behavioral Variant Frontotemporal Dementia

TRx0237 to Treat Behavioral Variant Frontotemporal Dementia

Overall Status: 
Recruiting
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 CodeStatusPrimary Contact

Geolocation is 34.070264, -118.4440562

Site
Los Angeles
California
90095
Recruiting
Name: Mario Mendez, MD
Phone: 310-794-2550
Email: mmendez@ucla.edu

Geolocation is 33.615828, -117.9307584

Site
Newport Beach
California
92663
Recruiting
Name: William Shankle, MD
Phone: 949-764-8190
Email: rshankle@mccare.com

Geolocation is 37.7748363, -122.3872576

Site
San Francisco
California
94158
Recruiting
Name: Adam Boxer, MD
Phone: 415-476-0661
Email: aboxer@memory.ucsf.edu

Geolocation is 28.5552719, -82.3878709

Site
Brooksville
Florida
34601
Recruiting
Name: Kelli Maw, MD
Phone: 352-597-8839
Email: kmaw@meridienresearch.net

Geolocation is 30.2606613, -81.460856

Site
Jacksonville
Florida
32224
Recruiting
Name: Neill Graff-Radford, MD
Phone: 904-953-6523
Email: graffradford.neill@mayo.edu

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name: Ira Goodman, MD
Phone: 407-426-9299
Email: drgoodman@compassresearch.com

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name: Jean Fils, MD
Phone: 813-974-2832
Email: jfils@health.usf.edu

Geolocation is 33.7980995, -84.3259367

Site
Atlanta
Georgia
30322
Recruiting
Name: William Hu, MD
Phone: 404-728-6443
Email: william.hu@emory.edu

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Recruiting
Name: Concetta Forchetti, MD
Phone: 847-593-8553
Email: concetta.forchetti@alexian.net

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Recruiting
Name: Brandy Matthews, MD
Phone: 317-963-7404
Email: brmatthe@iupui.edu

Geolocation is 39.2713976, -76.5603828

Site
Baltimore
Maryland
21224
Recruiting
Name: Chiadi Onyike, MD
Phone: 410-550-9054
Email: conyike1@jhmi.edu

Geolocation is 42.3652917, -71.0646337

Site
Boston
Massachusetts
02114
Recruiting
Name: Scott McGinnis, MD
Phone: 617-525-9539
Email: smmcginnis@partners.org

Geolocation is 44.0557303, -92.5253639

Site
Rochester
Minnesota
55905
Recruiting
Name: David Knopman, MD
Phone: 507-293-5354
Email: Knopman@mayo.edu

Geolocation is 40.2962222, -74.0509725

Site
Eatontown
New Jersey
07724
Recruiting
Name: Joel Ross, MD
Phone: 732-263-0101
Email: jrossmd@memorycenternj.com

Geolocation is 42.6547387, -73.7889689

Site
Albany
New York
12208
Recruiting
Name: Richard Holub, MD
Phone: 518-449-2662
Email: rholub@naaresearch.com

Geolocation is 40.5988077, -73.9447994

Site
Brooklyn
New York
11229
Recruiting
Name: Inna Yuryev-Golger, MD
Phone: 718-444-7774
Email: igolger@iclinicaltrials.net

Geolocation is 35.905249, -79.0581498

Site
Chapel Hill
North Carolina
27599
Recruiting
Name: Daniel Kaufer, MD
Phone: 919-966-8172
Email: kauferd@neurology.unc.edu

Geolocation is 41.5091257, -81.6089873

Site
Cleveland
Ohio
44106
Recruiting
Name: Alan Lerner, MD
Phone: 216-464-6412
Email: alan.lerner@uhhospitals.org

Geolocation is 35.5135639, -97.5788975

Site
Oklahoma City
Oklahoma
73112
Recruiting
Name: Marvin Peyton, MD
Phone: 405-753-4994
Email: drpeyton@okcrc.net

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
19046
Recruiting
Name: Marvin Kalafer, MD
Phone: 215-884-1700
Email: drkalafer@theclinicaltrialcenter.com

Geolocation is 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Recruiting
Name: Murray Grossman, MD
Phone: 215-662-3361
Email: mgrossma@mail.med.upenn.edu

Geolocation is 40.7078639, -111.8508966

Site
Salt Lake City
Utah
84106
Recruiting
Name: Miroslav Backonja, MD
Phone: 801-269-8200
Email: MBackonja@crilifetree.com

Geolocation is 42.878094, -73.1968001

Site
Bennington
Vermont
05201
Recruiting
Name: Lisa Capatano-Friedman, MD
Phone: 802-447-1409
Email: psingpsych1@gmail.com

Geolocation is 38.0293059, -78.4766781

Site
Charlottesville
Virginia
22903
Recruiting
Name: Erin Foff, MD
Phone: 434-243-5898
Email: epf4b@virginia.edu

Geolocation is 51.0662767, -114.1355032

Site
Calgary
Alberta
T2N 4Z6
Not yet recruiting
Name: David Patry, MD
Phone: 403-220-8394
Email: dgpatry@ucalgary.ca

Geolocation is 49.2650543, -123.2459921

Site
Vancouver
British Columbia
V6T 2B5
Recruiting
Name: Ging-Yuek Robin Hsiung, MD
Phone: (604) 822-3610
Email: hsiung@mail.ubc.ca

Geolocation is 48.4314591, -123.3274789

Site
Victoria
British Columbia
V8R 1J8
Recruiting
Name: Alex Henri-Bhargava, MD
Phone: 250-370-8261
Email: alexhb@uvic.ca

Geolocation is 44.6582865, -63.6700901

Site
Halifax
Nova Scotia
B3S 1M7
Not yet recruiting
Name: Mark Johnston, MD
Phone: 902-431-4433
Email: markerj1@me.com

Geolocation is 42.9555117, -81.2257216

Site
London
Ontario
N6C 5J1
Recruiting
Name: Elizabeth Finger, MD
Phone: (519) 646-6032
Email: Elizabeth.Finger@lhsc.on.ca

Geolocation is 43.7585342, -79.3535081

Site
Toronto
Ontario
M3B 2S7
Recruiting
Name: Sharon Cohen, MD
Phone: (416) 386-9761
Email: cohen@memorydisorders.ca

Geolocation is 43.6534023, -79.4053266

Site
Toronto
Ontario
M5T 2S8
Not yet recruiting
Name: Maria Carmela Tartaglia, MD
Phone: 416 603 5483
Email: carmela.tartaglia@uhn.on.ca

Geolocation is 45.4420201, -73.5800493

Site
Verdun
Quebec
H4H 1R3
Not yet recruiting
Name: Pedro Rosa-Neto, MD
Phone: 514 766 1009
Email: pedro.rosa@mcgill.ca
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