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Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

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

Keywords

Alzheimer's Disease Behavioral Variant Frontotemporal Dementia Dementia Alzheimer Disease bvFTD Frontotemporal Dementia Neurodegenerative Diseases Brain Diseases Cognitive Disorders

Eligibility

You can join if…

  • 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

You CAN'T join if...

  • 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

Locations

  • San Francisco Clinical Research Center
    San Francisco, California, 94118, United States
  • Memory and Aging Centre
    San Francisco, California, 94158, United States
  • Schuster Medical Research Institute
    Sherman Oaks, California, 91403, United States
  • Neuro-Therapeutics, Inc.
    Pasadena, California, 91105, United States
  • Neurological Research Institute
    Santa Monica, California, 90404, United States
  • Collaborative Neuroscience Network
    Long Beach, California, 90806, United States
  • Southern California Research, LLC
    Fountain Valley, California, 92708, United States
  • The Shankle Clinic
    Newport Beach, California, 92663, United States
  • Feldman, Robert MD
    Laguna Hills, California, 92653, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
TauRx Therapeutics Ltd
ID
NCT02245568
Phase
Phase 3
Lead Scientist
Adam Boxer
Study Type
Interventional
Last Updated
June 2016