Status:
TERMINATED
Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Lead Sponsor:
TauRx Therapeutics Ltd
Conditions:
Alzheimer's Disease
Behavioral Variant Frontotemporal Dementia
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
913 Patients enrolled
Trial Details
Trial ID
NCT02245568
Start Date
August 1 2014
End Date
May 1 2017
Last Update
May 24 2023
Active Locations (135)
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1
Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, United States, 85004
2
Southern California Research, LLC
Fountain Valley, California, United States, 92708
3
Feldman, Robert MD
Laguna Hills, California, United States, 92653
4
Collaborative Neuroscience Network
Long Beach, California, United States, 90806