Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01626391
Recruitment Status : Terminated (This study has been terminated for administrative reasons only.)
First Posted : June 22, 2012
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

June 20, 2012
June 22, 2012
April 28, 2014
July 11, 2014
July 11, 2014
September 2012
March 2013   (Final data collection date for primary outcome measure)
Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine [ Time Frame: 8 weeks ]
This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.
Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes [ Time Frame: 28 days ]
Safety parameters included adverse events, vital signs, methemoglobin, physical and neurological examinations, laboratory tests (hematology, serum chemistry, urinalysis, and troponin), electrocardiograms, and potential for suicidal behaviour and thoughts.
Complete list of historical versions of study NCT01626391 on Archive Site
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Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease
A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: TRx0237
    TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks
  • Drug: Placebo
    Placebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.
  • Experimental: TRx0237
    Intervention: Drug: TRx0237
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Clinical diagnosis of all cause dementia and probable Alzheimer's disease (AD)
  • Mini-Mental State Examination (MMSE) score of 14-26 (inclusive)
  • Cognitive impairment present for at least 6 months
  • Age ≤90 years
  • Modified Hachinski ischaemic score of ≤4
  • Females, if of childbearing potential, must use adequate contraception and maintain this use throughout participation in the study
  • Patient is able to read, understand, and provide written informed consent
  • Has one or more identified caregivers who are able to verify daily compliance with study drug and provide information on safety and tolerability; the caregiver(s) must also give consent to participate
  • Currently taking an taking an acetylcholinesterase inhibitor and/or memantine; the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
  • Able to comply with the study procedures

Exclusion Criteria:

  • Significant central nervous system disorder other than Alzheimer's disease
  • Patients in whom baseline MRI is contraindicated such as metal implants in head (except dental), pacemaker, and cochlear implant
  • Significant focal or intracranial pathology that would lead to a diagnosis other than probable Alzheimer's disease
  • 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 or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
  • Resides in a hospital or continuous care facility
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • History of significant hematological abnormality or current acute or chronic clinically significant abnormality
  • Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator
  • Clinically significant cardiovascular disease or abnormal assessments
  • Pre-existing or current signs or symptoms of respiratory failure
  • Concurrent acute or chronic clinically significant immunologic, renal, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
  • Prior intolerance to methylthioninium-containing drug or any of the excipients
  • Treatment currently or within 3 months before Baseline with any of the following medications (unless otherwise noted):

    • Tacrine
    • Anxiolytics and/or sedatives/hypnotics (exceptions: sedation for MRI or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime)
    • Antipsychotics (clozapine, chlorpromazine, thioridazine, or ziprasidone)
    • Carbamazepine
    • Drugs associated with methaemoglobinaemia (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine and related antimalarials, sulfonamides)
    • Warfarin (and other Coumadin derivates such as phenprocoumon)
  • Current or prior participation in a clinical trial of a drug, biologic, or device in which the last dose was received within 28 days prior to Baseline
Sexes Eligible for Study: All
up to 90 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
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TauRx Therapeutics Ltd
TauRx Therapeutics Ltd
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Principal Investigator: Mark Dale, MD MAC Clinical Research
TauRx Therapeutics Ltd
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP