Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

Phase 3

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
LMTM	LMTM	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious or Non-serious Adverse Events	Up to 34 months	Study-emergent adverse events (including the onset of new adverse events or worsening of pre-existing adverse events) were recorded from the time of first dose in this study to the end of study participation. All laboratory test, vital sign, or electrocardiogram parameter abnormalities deemed clinically significant by the Investigator were to be reported as adverse events.

Secondary Outcome Measures

Name	Time	Method

Locations (132): Xenoscience, Inc / 21st Century Neurology
🇺🇸
Phoenix, Arizona, United States
Southern California Research, LLC
🇺🇸
Fountain Valley, California, United States
Feldman, Robert MD
🇺🇸
Laguna Hills, California, United States
Collaborative Neuroscience Network
🇺🇸
Long Beach, California, United States
The Shankle Clinic
🇺🇸
Newport Beach, California, United States
Neuro-Therapeutics, Inc.
🇺🇸
Pasadena, California, United States
Pacific Research Network
🇺🇸
San Diego, California, United States
San Francisco Clinical Research Center
🇺🇸
San Francisco, California, United States
Memory and Aging Centre
🇺🇸
San Francisco, California, United States
Schuster Medical Research Institute
🇺🇸
Sherman Oaks, California, United States
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Xenoscience, Inc / 21st Century Neurology
🇺🇸Phoenix, Arizona, United States