Start: November 2012
End: May 2016
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?
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
- 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.
Who Is the General Study Contact?
For more information about this trial or study sites, contact Karen Pozzie at 1-800-910-5609 or firstname.lastname@example.org.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: TauRx Therapeutics Ltd.
Source: ClinicalTrials.gov ID: NCT01689233