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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 June 2023
• Main ID: NCT02245568
• Date of registration: 27/08/2014
• Prospective Registration: No
• Primary sponsor: TauRx Therapeutics Ltd
• Public title: Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
• Scientific title: An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
• Date of first enrolment: August 2014
• Target sample size: 913
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02245568
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Croatia, Finland, France, Germany, Italy, Korea, Republic of, Malaysia, Netherlands, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Behavioral Variant Frontotemporal Dementia

Alzheimer's Disease

Intervention(s)

Drug: LMTM

Primary Outcome(s)

Number of Participants With Serious or Non-serious Adverse Events [Time Frame: Up to 34 months]

Secondary ID(s)

TRx-237-020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02245568