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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: TRx0237; Drug: Placebo

• Registration Number: NCT01626391
• Lead Sponsor: TauRx Therapeutics Ltd

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 available

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-22
• Study Start: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-04-28
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-10
• Last Update Submitted: 2014-06-10
• Results First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRx0237	TRx0237	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine	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.