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

Inclusion Criteria:

• Subjects with all cause dementia and probable Alzheimer's disease at enrollment andwho completed participation in one of the following three TauRx studies (inclusive ofthe 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 completedparticipation in TauRx study TRx-237-007 through Visit 9 (Week 52).
• Females, if of child-bearing potential, must practice true abstinence or continue touse adequate contraception and agree to maintain this throughout the study
• Subject, and/or, in the case of reduced decision-making capacity, legally acceptablerepresentative(s) consistent with national law and ethics approval is/are able toread, understand, and provide written informed consent
• Has an identified adult caregiver who is willing to provide written informed consentfor his/her own participation; is able to read, understand, and speak the designatedlanguage at the study site; either lives with the subject or sees the subject for ≥1hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and isable 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 imagingabnormality (in originating study) or emergent intercurrent illness that, in thejudgment of the principal investigator, could result in the risk of participationoutweighing 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 livingfacility or those whose willingness to participate in the clinical trial may be undulyinfluenced