Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

Brief Summary

Official Title: “A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)”

The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the treatment of patients with behavioral variant frontotemporal dementia (bvFTD).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2015

Interventions Used in this Clinical Trial

  • Drug: TRx0237
    • TRx0237 100 mg tablet will be administered twice daily.
  • Drug: Placebo
    • Placebo tablets will be administered twice daily. The placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: TRx0237 200 mg/day group
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from Baseline on Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (modified ADCS-CGIC)
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Change from Baseline on Addenbrooke’s Cognitive Examination – Revised (ACE-R)
    • Time Frame: 52 weeks
      Safety Issue?: No

Secondary Measures

  • Change from Baseline on Unified Parkinson’s Disease Rating Scale (UPDRS Parts II and III)
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Change from Baseline on Frontotemporal Dementia Rating Scale (FRS)
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Change from Baseline on Functional Activities Questionnaire (FAQ)
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
    • Time Frame: 52 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Diagnosis of probable bvFTD
  • Centrally rated frontotemporal atrophy score of 2 or greater on brain MRI
  • MMSE ≥20
  • Age <80 years
  • Modified Hachinski ischemic score of ≤ 4
  • Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
  • Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent
  • Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
  • If currently 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 (CNS) disorder other than bvFTD
  • Significant focal or vascular intracranial pathology seen on brain MRI scan
  • Biomarker evidence of underlying Alzheimer's disease pathology
  • Expressive language deficits
  • Meets research criteria for Amyotrophic Lateral Sclerosis or motor neuron disease
  • Meets diagnostic criteria for probable bvFTD but has a proven mutation producing non-tau, non-TDP-43 pathology
  • Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
  • Epilepsy
  • Rapid eye movement sleep behavior disorder
  • Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
  • Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI; magnetic resonance compatible prosthetics, clips, stents, or any other device proven to be compatible will be allowed
  • Resides in hospital or moderate to high dependency continuous care facility
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Glucose-6-phosphate dehydrogenase deficiency
  • 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
  • Preexisting or current signs or symptoms of respiratory failure
  • Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than bvFTD
  • Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
  • Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
  • Treatment currently or within 3 months before Baseline with any of the following medications (unless otherwise noted):
  • Tacrine
  • Amphetamine or dexamphetamine
  • Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
  • Carbamazepine, primidone
  • Drugs associated with methemoglobinemia
  • Current or prior participation in a clinical trial as follows:
  • Clinical trial of a product for cognition within 3 months (unless confirmed to have been randomized to placebo)
  • A clinical trial of a drug, biologic, device, or medical food in which the last dose/administration was received within 28 days prior to Baseline

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • TauRx Therapeutics Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Karen Pozzie, 1-888-570-3142, info@dementiastudy.net

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01626378