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

NCT01626391 | Terminated Phase 2 Results DMC

• 1 other identifier: TRx-237-008
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 12

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; TRx0237; Safety Study; AD

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine

  This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.

  8 weeks

Study Arms (2)

TRx0237

EXPERIMENTAL

Drug: TRx0237

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TRx0237 DRUG

TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks

TRx0237

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TauRx Therapeutics Ltd: lead

Study Sites (12)

Unknown Facility

Achim, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Leipzig, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Bradford, United Kingdom

Location

Unknown Facility

Crowborough, United Kingdom

Location

Unknown Facility

Duston, United Kingdom

Location

Unknown Facility

Oxford, United Kingdom

Location

Unknown Facility

Saint Leonards-on-Sea, United Kingdom

Location

Unknown Facility

Sheffield, United Kingdom

Location

Unknown Facility

Staffordshire, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

hydromethylthionine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Jiri Hardlund
• Organization: TauRx Therapeutics Ltd

JHH@taurx.com

+44 (0)1224438550

Study Officials

• Mark Dale, MD

  MAC Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 11, 2014
• Results First Posted: July 11, 2014

Record last verified: 2014-06

Locations

DE (4); GB (8)