An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia

Phase 3

Recruiting

• Conditions: Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia); 10007963

• Registration Number: NL-OMON41951
• Lead Sponsor: TauRx Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

1. Subjects with a diagnosis according to NIA/AA criteria of all cause dementia and probable Alzheimer*s disease (AD) 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 who participated in Study TRx-237-015 and did not consent to extended treatment for up to 15 months as per Protocol Version 3.0 (extended from 12 months as per the original study protocol) may be enrolled into this open-label extension study following completion of the 12-month double-blind treatment period and 4-week post-treatment follow-up visit for Study TRx-237-015.);OR ;Subjects with a diagnosis of probable bvFTD according to the International Consensus Criteria for behavioral variant frontotemporal dementia (bvFTD) at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52). ;Treatment will not be made available to subjects who have withdrawn from the double-blind study of prior participation prior to completion.;2. Females of child-bearing potential must continue to use adequate contraception (or, if in Italy, agree to avoid pregnancy) defined as follows:
• barrier method (such as condom, diaphragm or cervical/vault cap) with spermicidal foam, gel, film, cream, or suppository; intrauterine device (IUD) or system; oral or long-acting injected or implanted hormonal contraceptives for at least 3 months prior to Baseline; or vasectomized partner (with the appropriate post-vasectomy documentation of the absence of spermatozoa in the ejaculate); or true abstinence (when this is in line with the preferred and usual lifestyle of the subject)
• subjects must agree to continue to maintain adequate contraception throughout participation in the study;3. Subject and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and IRB/EC approval, is/are able to read, understand, and provide written informed consent in the designated language of the study site;4. Has an identified adult caregiver who meets the following criteria:
• Either lives with the subject or sees the subject on average for >= 1 hour/day >= 3 days/week, and in the investigator*s opinion, the extent of contact is sufficient to provide meaningful assessment of changes in subject behavior and function over time and provide information on safety and tolerability
• 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
• Agrees to accompany the subject to each study visit
• Is able to verify daily compliance with study drug;5. Able to comply with the study procedures in the view of the investigator

Exclusion Criteria

1. History of swallowing difficulties (note: study drug should be swallowed whole and MUST NOT be broken crushed, chewed or dissolved in fluids prior to ingestion);2. Pregnant or breastfeeding;3. Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in original study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit;4. Current participation in, or intent to enroll in, a clinical trial of a drug, biologic, device, or medical food

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objectives of this study are to provide subjects who have completed<br /><br>participation in a Phase 2 or Phase 3 trial continued access to<br /><br>therapy and to evaluate the long-term safety and tolerability of LMTM given in<br /><br>flexible doses of up to 300 mg/day.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>