Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Condition: Alzheimer's Disease; Behavioral Variant Frontotemporal Dementia
MeSH terms: Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Intervention: LMTM
Intervention description: The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 913.0
Sex: All
Healthy volunteers: No
Keywords: Dementia; Alzheimer Disease; bvFTD; Frontotemporal Dementia; Neurodegenerative Diseases; Brain Diseases; Cognitive Disorders

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 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