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Open-Label Study of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

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ClinicalTrials.gov Identifier: NCT02245568
Recruitment Status : Terminated
First Posted : September 19, 2014
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

Study Description
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Brief Summary:
The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term safety of TRx0237.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral Variant Frontotemporal Dementia Drug: TRx0237 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 913 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Extension Study of the Effects of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Study Start Date : August 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TRx0237 Drug: TRx0237
All subjects will initially be given 200 mg/day of TRx0237 (one 100-mg tablet in the morning and one 100-mg tablet in the evening). Thereafter, dosing is flexible (100 mg/day to 300 mg/day).


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with serious and non-serious adverse events [ Time Frame: Up to 34 months ]
  2. Change from Baseline in laboratory test values [ Time Frame: Up to 34 months ]
    Standard hematology and serum chemistry parameters to be measured

  3. Change from Baseline in vital signs [ Time Frame: Up to 34 months ]
    Vital signs to be measured include blood pressure and pulse, temperature, respiratory rate and weight

  4. Change from Baseline in electrocardiograms [ Time Frame: Up to 34 months ]

Other Outcome Measures:
  1. Score of Euro Quality of Life - 5-level version (EQ-5D-5L) [ Time Frame: Up to 34 months ]
  2. Score of Resource Utilization in Dementia Questionnaire-Lite (RUD-Lite) [ Time Frame: Up to 34 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with all cause dementia and probable Alzheimer's disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.
  • Subjects with a diagnosis of probable bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).
  • Females, if of child-bearing potential, must practice true abstinence or continue 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 and ethics approval is/are able to read, understand, and provide written informed consent
  • Has an 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 ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
  • Able to comply with the study procedures

Exclusion Criteria:

  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit
  • Current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food
  • In Germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245568


  Show 136 Study Locations
Sponsors and Collaborators
TauRx Therapeutics Ltd
More Information
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Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT02245568     History of Changes
Other Study ID Numbers: TRx-237-020
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by TauRx Therapeutics Ltd:
Dementia
Alzheimer Disease
bvFTD
Frontotemporal Dementia
 Neurodegenerative Diseases
Brain Diseases
Cognitive Disorders

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
 TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action