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TRx0237 for Mild Alzheimer's Disease

Start: November 2012

End: May 2016

Enrollment: 500

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: N/A

Maximum Age: 89 Years

Must have:

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

Must NOT have:

  • 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Who Is the General Study Contact?

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

Where Is This Study Located?

Arizona
Xenoscience, Inc / 21st Century Neurology
Phoenix, 85004
NoesisPharma Clinical Trials
Phoenix, 85032
California
CITrials
Bellflower, 90706
ATP Clinical Research, Inc.
Costa Mesa, 92626
Southern California Research, LLC
Fountain Valley, 92708
Feldman, Robert MD
Laguna Hills, 92653
Synergy East
Lemon Grove, 91945
Collaborative Neuroscience Network
Long Beach, 90806
Neuro-Therapeutics, Inc.
Pasadena, 91105
Anderson Clinical Research
Redlands, 92374
Pacific Research Network
San Diego, 92103
San Francisco Clinical Research Center
San Francisco, 94118
Neurological Research Institute
Santa Monica, 90404
Schuster Medical Research Institute
Sherman Oaks, 91403
Colorado
Mile High Research Center
Denver, 80218
Connecticut
Institute for Neurodegenerative Disorders
New Haven, 06510
Coastal Connecticut Research, LLC
New London, 06320
Research Center for Clinical Studies, Inc
Norwalk, 06851
Florida
JEM Research
Atlantis, 33462
Bradenton Research Center
Bradenton, 34205
Meridien Research
Brooksville, 34601
Brain Matters Research
Delray Beach, 33445
MD Clinical
Hallandale Beach, 33009
Alzheimer's Research and Treatment Center
Lake Worth, 33449
Compass Research, LLC
Orlando, 32806
The Roskamp Institute, Inc.
Sarasota, 34243
Axiom Clinical Research of Florida
Tampa, 33609
USF Health Byrd Alzheimer's Institute
Tampa, 33613
Compass Research, LLC - North Clinic
The Villages, 32162
Premiere Research Institute (Palm Beach Neurology)
West Palm Beach, 33407
Georgia
Atlanta Center for Medical Research
Atlanta, 30331
Neurostudies.net
Decatur, 30033
Illinois
Alexian Brothers Neurosciences Institute
Elk Grove, 60007
Iowa
Ruan Neurology Clinic and Research Center
Des Moines, 50314
Maryland
CBH Health, LLC
Rockville, 20850
Michigan
Quest Research Institute
Farmington Hills, 48334
Mississippi
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, 39401
Olive Branch Family Medical
Olive Branch, 38654
Missouri
Millennium Psychiatric Associates
Creve Coeur, 63141
New Jersey
Memory Enhancement Centers of America, Inc
Eatontown, 07724
Advanced Memory Research Institute of NJ PC
Toms River, 08757
New Mexico
Albuquerque Neuroscience
Albuquerque, 87109
New York
Neurological Associates of Albany, P. C.
Albany, 12208
MedicalPsych Care, PLLC
Elmsford, 10523
Columbia University Taub Institute
New York, 10032
Research Foundation for Mental Hygiene, Inc.
Orangeburg, 10962
North Carolina
Wake Research Associates
Raleigh, 27612
Clinical Trials of America, Inc
Winston-Salem, 27103
Ohio
Neurobehavorial Clinical Research
Canton, 44718
Oklahoma
Oklahoma Clinical Research Center
Oklahoma City, 73112
Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, 19046
Rhode Island
RI Hospital
Providence, 02903
Tennessee
Neurology Clinic, P.C.
Cordova, 38018
Clinical Neuroscience Solutions CNS Healthcare
Memphis, 38119
Texas
Senior Adults Specialty Research, Inc.
Austin, 78757
FutureSearch Trials of Dallas, LP
Dallas, 75231
Utah
PRA Health Sciences
Salt Lake City, 84107
Wisconsin
Independent Psychiatric Consultants
Waukesha, 53188
British Columbia
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, V6T 1Z3
Ontario
Parkwood Institute
London, N6C 0A7
Toronto Memory Program
Toronto, M3B 2S7
Quebec
Jewish General Hospital
Montreal, H3T 1E2

Who Sponsors This Study?

Lead: TauRx Therapeutics Ltd.

Source: ClinicalTrials.gov ID: NCT01689233