Start: December 2012
End: November 2015
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 to moderate Alzheimer's disease.
Do I Qualify To Participate in This Study?
- 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
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, 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
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 its study sites, please contact Bernard Hall 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: NCT01689246