Alzheimer's Disease Education and Referral Center

TRx0237 for Mild Alzheimer's Disease

TRx0237 for Mild 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 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 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 33.6364503, -112.0118669

Site
Phoenix
Arizona
85032
Recruiting
Name: Lee Ann Kelley, MD
Phone: 602-795-1834
Email: lak@kelleymd.com

Geolocation is 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Recruiting
Name: Gustavo Alva, MD
Phone: 714-277-4472
Email: galva@theatpgroup.net

Geolocation is 33.9372725, -118.1298234

Site
Downey
California
90241
Recruiting
Name: Elizabeth Zarate-Rowell, MD
Phone: 562-622-0700
Email: elizabethrowellmd@diligentclinicaltrials.com

Geolocation is 33.090285, -117.0499859

Site
Escondido
California
92025
Recruiting
Name: Charmaine Semeniuk, MD
Phone: 760-871-0286
Email: semeniukc@synergyescondido.com

Geolocation is 33.7091847, -117.9536697

Site
Fountain Valley
California
92708
Recruiting
Name: John Murphy, MD
Phone: 714-665-1277
Email: jjmurphy@SCRstudies.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 33.8065036, -118.1912538

Site
Long Beach
California
90806
Recruiting
Name: Omid Omidvar, MD
Phone: 877-411-1616
Email: omidomidvar@cnstrial.com

Geolocation is 34.1406082, -118.1678543

Site
Pasadena
California
91105
Recruiting
Name: Richard Shubin, MD
Phone: 626-356-0800
Email: neuro47@sbcglobal.net

Geolocation is 34.0708773, -117.1558867

Site
Redlands
California
92374
Recruiting
Name: Don Anderson, MD
Phone: 909-792-9007
Email: dla@andersonstudies.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 34.02875, -118.4717975

Site
Santa Monica
California
90404
Recruiting
Name: David Kudrow, MD
Phone: 310-315-1456
Email: dbkudrow@earthlink.net

Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Recruiting
Name: Martin Schuster, MD
Phone: 818-788-0746
Email: schuster@smrionline.com

Geolocation is 39.732746, -104.9710123

Site
Denver
Colorado
80218
Recruiting
Name: Jack Klapper, MD
Phone: 303-877-2429
Email: jkheaddoc@gmail.com

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Recruiting
Name: Dana Jennings, MD
Phone: 203-401-4300
Email: Djennings@indd.org

Geolocation is 41.3631426, -72.106068

Site
New London
Connecticut
06320
Recruiting
Name: Laurence Radin, MD
Phone: 860-437-7092
Email: DrRadin.CCR@gmail.com

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Recruiting
Name: Bart Sloan, MD
Phone: 203-838-0070
Email: bsloan@rccsmail.com

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 27.4872771, -82.5889012

Site
Bradenton
Florida
34205
Recruiting
Name: William McElveen, MD
Phone: 941-708-0005
Email: wam_md@bradentonresearch.com

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 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Recruiting
Name: Mark Brody, MD
Phone: 561-764-8461
Email: mbrody@brainmattersresearch.com

Geolocation is 26.621043, -81.8333656

Site
Fort Myers
Florida
33916
Recruiting
Name: Ronica Kluge, MD
Phone: 239-936-4421
Email: rkluge@clinphys.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 26.5907805, -80.2432839

Site
Lake Worth
Florida
33449
Recruiting
Name: Michael Neam, MD
Phone: 561-209-2400
Email: mneam@researchalz.com

Geolocation is 28.810823, -81.8778582

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

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name: Marc Agronin, MD
Phone: 305-751-8626
Email: MAgronin@mjhha.org

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name: Craig Curtis, MD
Phone: 407-426-9299
Email: Drcurtis@compassresearch.com

Geolocation is 26.98699, -82.09518

Site
Port Charlotte
Florida
33952
Recruiting
Name: Liliana Montoya, MD
Phone: 941-743-1027
Email: Neurostudies4@daystar.net

Geolocation is 27.4081935, -82.5294065

Site
Sarasota
Florida
34243
Recruiting
Name: Andrew Keegan, MD
Phone: 941-256-8018
Email: akeegan@rfdn.org

Geolocation is 26.17785, -80.2711588

Site
Sunrise
Florida
33351
Recruiting
Name: Richard Singer, MD
Phone: 954-475-8171
Email: rsinger@neuroresearch.net

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name: Balebail Raj, MD
Phone: 813-874-1294
Email: Braj@health.usf.edu

Geolocation is 27.9407591, -82.5104655

Site
Tampa
Florida
33609
Recruiting
Name: Susan Steen, MD
Phone: 813-353-9613
Email: Ssteen.axiom@gmail.com

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Recruiting
Name: Carl Sadowsky, MD
Phone: 561-845-0500
Email: chsadow@aol.com

Geolocation is 33.7717008, -84.3726049

Site
Atlanta
Georgia
30308
Recruiting
Name: Robert Riesenberg, MD
Phone: 404-881-5800
Email: rriesenberg@acmr.org

Geolocation is 33.8092255, -84.2805478

Site
Decatur
Georgia
30033
Recruiting
Name: Marshall Nash, MD
Phone: 404-475-0552
Email: mnash@neurostudies.net

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 41.608982, -93.6268464

Site
Des Moines
Iowa
50314
Recruiting
Name: Michael Jacoby, MD
Phone: 515-358-0023
Email: iowaclinicalresearch@mercydesmoines.org

Geolocation is 39.0839973, -77.1527578

Site
Rockville
Maryland
20850
Recruiting
Name: Robert Litman, MD
Phone: 301-251-4702
Email: relitman@cbhhealth.com

Geolocation is 42.7262016, -71.1908924

Site
Methuen
Massachusetts
01844
Recruiting
Name: Michael McCartney, MD
Phone: 978-655-7155
Email: mmccartney@activmedresearch.com

Geolocation is 42.3028239, -71.1864397

Site
Newton
Massachusetts
02459
Recruiting
Name: Michael Biber, MD
Phone: 617-581-6434
Email: mbiber@bidmc.harvard.edu

Geolocation is 42.5049385, -83.3468784

Site
Farmington Hills
Michigan
48334
Recruiting
Name: Aaron Ellenbogen, MD
Phone: 248-957-8940
Email: aaron@questri.com

Geolocation is 31.3271189, -89.2903392

Site
Hattiesburg
Mississippi
39401
Recruiting
Name: Ronald Schwartz, MD
Phone: 601-573-5345
Email: ronald.schwartz@hattiesburgclinic.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 38.6608855, -90.422618

Site
Creve Coeur
Missouri
63141
Recruiting
Name: Franco Sicuro, MD
Phone: 314-298-0001
Email: fsicuro@millenniumpa.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 39.9471038, -74.2531465

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

Geolocation is 35.1590068, -106.5760857

Site
Albuquerque
New Mexico
87109
Recruiting
Name: Glen Michael Dempsey, MD
Phone: 505-848-3773
Email: gmdempsey@albneuro.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 41.0550969, -73.8201337

Site
Elmsford
New York
10523
Recruiting
Name: James Chou, MD
Phone: 914-345-9154
Email: JimChou66@medicalpsychcare.com

Geolocation is 42.7539447, -73.7830861

Site
Latham
New York
12110
Recruiting
Name: Keith Edwards, MD
Phone: 518-785-1000
Email: kedwards@tristateneuro.com

Geolocation is 40.8409822, -73.9447994

Site
New York
New York
10032
Recruiting
Name: Lawrence Honig, MD
Phone: 212-305-2371
Email: lh456@cumc.columbia.edu

Geolocation is 41.0464858, -73.9495818

Site
Orangeburg
New York
10962
Recruiting
Name: Nunzio Pomara, MD
Phone: 845-398-5579
Email: pomara@nki.rfmh.org

Geolocation is 40.555548, -74.1827119

Site
Staten Island
New York
10312
Recruiting
Name: Mark DiBuono, MD
Phone: 718-317-5522
Email: dibuono@rbany.com

Geolocation is 35.8533273, -78.6965972

Site
Raleigh
North Carolina
27612
Recruiting
Name: Singar Jadadeesan, MD
Phone: 919-781-2514
Email: sjagadeesan@wakeresearch.com

Geolocation is 36.0564654, -80.3324514

Site
Winston-Salem
North Carolina
27103
Recruiting
Name: Beverly Jones, MD
Phone: 336-768-3456
Email: bjones@ctamerica.net

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 35.5135639, -97.5788975

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

Geolocation is 35.5135639, -97.5788975

Site
Oklahoma City
Oklahoma
73112
Recruiting
Name: Amal Chakrburtty, MD
Phone: 405-759-5600
Email: drchakraburtty@redriverokc.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 41.8164902, -71.3646236

Site
East Providence
Rhode Island
02914
Recruiting
Name: John Stoukides, MD
Phone: 401-435-8950
Email: jstoukides@rimmri.com

Geolocation is 41.816736, -71.4091563

Site
Providence
Rhode Island
02903
Recruiting
Name: Brian Ott, MD
Phone: 401-444-6440
Email: bott@lifespan.org

Geolocation is 35.1376546, -89.7661527

Site
Cordova
Tennessee
38018
Recruiting
Name: Lee Stein, MD
Phone: 901-866-9252
Email: research@neuroclinic.org

Geolocation is 35.0772572, -89.84582

Site
Memphis
Tennessee
38119
Recruiting
Name: Lora McGill, MD
Phone: 901-843-1045
Email: Lmcgill@cnshealthcare.com

Geolocation is 30.3507705, -97.7362384

Site
Austin
Texas
78757
Recruiting
Name: Jaron Winston, MD
Phone: 512-407-8628
Email: jw@senioradults.net

Geolocation is 32.8798071, -96.7547522

Site
Dallas
Texas
75231
Recruiting
Name: Michael Downing, MD
Phone: 214-369-2600
Email: michaeld@fstrials.com

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 Catapano-Friedman, MD
Phone: 802-447-1409
Email: Psingpsych1@gmail.com

Geolocation is 43.0116784, -88.2314813

Site
Waukesha
Wisconsin
53188
Recruiting
Name: Cary Kohlenberg, MD
Phone: 262-513-0700
Email: caryjkohlenberg@gmail.com

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: Robin Hsiung, MD
Phone: 604-822-1782
Email: hsiung@mail.ubc.ca

Geolocation is 42.9555117, -81.2257216

Site
London
Ontario
N6C 5J1
Recruiting
Name: Stephen Pasternak, MD
Phone: 519-685-4292
Email: spasternak@robarts.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 45.4976084, -73.6292768

Site
Montreal
Quebec
H3T 1E2
Recruiting
Name: Howard Cherktow, MD
Phone: 514-340-8222
Email: howard.chertkow@mcgill.ca
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