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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

Tracking Information
First Submitted Date  ICMJE June 20, 2012
First Posted Date  ICMJE June 22, 2012
Results First Submitted Date April 28, 2014
Results First Posted Date July 11, 2014
Last Update Posted Date July 11, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
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.
Change History Complete list of historical versions of study NCT01626391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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.
Study Arms
  • Experimental: TRx0237
    Intervention: Drug: TRx0237
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2012)
60
Actual Study Completion Date March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01626391
Other Study ID Numbers  ICMJE TRx-237-008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party TauRx Therapeutics Ltd
Study Sponsor  ICMJE TauRx Therapeutics Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Dale, MD MAC Clinical Research
PRS Account TauRx Therapeutics Ltd
Verification Date June 2014

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