Clinical trial NCT01626391: Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
TRx0237
Safety Study
AD
Lead sponsor: TauRx Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 9
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Achim
country: Germany
city: Berlin
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Birmingham
country: United Kingdom
city: Bradford
country: United Kingdom
city: Crowborough
country: United Kingdom
city: Duston
country: United Kingdom
city: Oxford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: St Leonards on Sea
country: United Kingdom
city: Staffordshire
country: United Kingdom
Study officials:
affiliation: MAC Clinical Research
name: Mark Dale, MD
role: PRINCIPAL_INVESTIGATOR
References: