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

• Sponsor: TauRx Therapeutics Ltd
• Information provided by (Responsible Party): TauRx Therapeutics Ltd

Study Description

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

Arms and Interventions

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

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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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
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:

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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