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

Stopped early · Phase 3

Conditions studied: Alzheimer's Disease, Behavioral Variant Frontotemporal Dementia

In brief

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.

Key facts

Study ID

NCT02245568

Run by

TauRx Therapeutics Ltd

People needed

913

Starts

2014-08-01

Expected to finish

2017-05-01

Last updated by the study team

2023-05-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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

Where it is running

• 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
• Mile High Research Center — Denver, Colorado, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• JEM Research — Atlantis, Florida, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• CNS Healthcare, Inc — Jacksonville, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• The Roskamp Institute, Inc. — Sarasota, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Xenoscience, Inc / 21st Century Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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