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: 
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
Recruiting
Name: Stephen Flitman, MD
Phone: 602-274-9500
Email: sflitman@xenoscience.com

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
92653
Recruiting
Name: Robert Feldman, MD
Phone: 949-588-0909
Email: rgfeldman@cox.net

Geolocation is 34.0502898, -118.2117257

Site
Los Angeles
California
90033
Recruiting
Name: Lon Schneider, MD
Phone: 323-442-7600
Email: lschneid@usc.edu

Geolocation is 33.6392245, -117.8647782

Site
Newport Beach
California
92658
Recruiting
Name: William Shankle, MD
Phone: 949-478-8858
Email: rshankle@mccare.com

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Recruiting
Name: Stephen Thein, PhD
Phone: 619-294-4302
Email: sthein@prnsd.com

Geolocation is 37.7822891, -122.463708

Site
San Francisco
California
94118
Recruiting
Name: Jerome Goldstein, MD
Phone: 415-673-4600
Email: SFHACLIN@aol.com

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Recruiting
Name: Christopher VanDyck, MD
Phone: 203-764-8100
Email: christopher.vandyck@yale.edu

Geolocation is 26.5909025, -80.1008762

Site
Atlantis
Florida
33462
Recruiting
Name: Mark Goldstein, MD
Phone: 561-968-2933
Email: MGoldstein@jemri.net

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Recruiting
Name: Mark Brody, MD
Phone: 561-374-8461
Email: mbrody@brainmattersresearch.com

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Recruiting
Name: Beth Safirstein, MD
Phone: 954-455-5757
Email: bsafirstein@mdclinical.org

Geolocation is 30.2205397, -81.5537192

Site
Jacksonville
Florida
32256
Recruiting
Name: John Joyce, MD
Phone: 904-281-5757
Email: mjoyce@cnshealthcare.com

Geolocation is 28.810823, -81.8778582

Site
Leesburg
Florida
34748
Recruiting
Name: James McDonough, MD
Phone: 352-261-0901
Email: drmcdonough@compassresearch.com

Geolocation is 25.6993807, -80.2934522

Site
Miami
Florida
33143
Recruiting
Name: Bruce Kohrman, MD
Phone: 305-279-0015
Email: bkohrman@gmail.com

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name: Kevin Radbill, DO
Phone: 407-426-9299
Email: drradbill@compassresearch.com

Geolocation is 33.7748275, -84.2963123

Site
Decatur
Georgia
30030
Recruiting
Name: Michael Burke, MD
Phone: 404-537-1281
Email: drburke@iresearchatlanta.com

Geolocation is 42.0408898, -87.9922684

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

Geolocation is 42.7262016, -71.1908924

Site
Methuen
Massachusetts
01844
Recruiting
Name: Michael McCartney, MD
Phone: 603-319-8863
Email: mmccartney@activmedresearch.com

Geolocation is 42.3028239, -71.1864397

Site
Newton
Massachusetts
02459
Recruiting
Name: Michael Biber, MD
Phone: 617-581-6434
Email: mchlbiber1@gmail.com

Geolocation is 34.9617604, -89.8295315

Site
Olive Branch
Mississippi
38654
Recruiting
Name: Randall Huling, MD
Phone: 662-893-8474
Email: rhuling@obfmc.com

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 39.8912248, -74.9218324

Site
Marlton
New Jersey
08053
Recruiting
Name: Steven Glass, MD
Phone: 856-334-6062
Email: sglass@crilifetree.com

Geolocation is 40.7102067, -74.3081167

Site
Springfield
New Jersey
07801
Recruiting
Name: Michelle Papka, PhD
Phone: 973-850-4622
Email: mpapka@thecrcnj.com

Geolocation is 39.9471038, -74.2531465

Site
Toms River
New Jersey
08757
Recruiting
Name: Sanjiv Sharma, MD
Phone: 732-341-9500
Email: ssharma@amrinj.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 40.5860069, -73.9418603

Site
Brooklyn
New York
11235
Recruiting
Name: Nick Vatakis, MD
Phone: 718-616-2400
Email: nvatakis@spristudy.com

Geolocation is 40.8540649, -81.460856

Site
Canton
Ohio
44718
Recruiting
Name: Shishuka Malhotra, MD
Phone: 330-493-1118
Email: smalhotra@nb-cr.com

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 30.3542409, -97.7742702

Site
Austin
Texas
78731
Recruiting
Name: John Hudson, MD
Phone: 512-380-9595
Email: jdh@sleepdoc.net

Geolocation is 49.8900709, -119.4931005

Site
Kelowna
British Columbia
V1Y 1Z9
Recruiting
Name: Paul Latimer, MD, PhD
Phone: 1 250 862 8141
Email: dr@oktrials.ca

Geolocation is 45.0836805, -64.497142

Site
Kentville
Nova Scotia
B4N 4K9
Recruiting
Name: Mark Johnston, MD
Phone: 1 902 679 0536
Email: mark.johnston@truenorthcr.com

Geolocation is 43.7585342, -79.3535081

Site
North York
Ontario
M3B 2S7
Recruiting
Name: Sharon Cohen, MD
Phone: 1 416 386 9761
Email: cohen@memorydisorders.ca

Geolocation is 45.4420201, -73.5800493

Site
Montreal
Quebec
H4H 1R3
Recruiting
Name: René Desautéls, MD
Phone: 1 514 761 6131
Email: rene.desautels@douglas.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 
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