An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial

Phase 1

• Conditions: Alzheimer’s Disease and behavioral variant Frontotemporal Dementia; MedDRA version: 18.1Level: PTClassification code 10068968Term: Frontotemporal dementiaSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-002013-37-BE
• Lead Sponsor: TauRx Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-31
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

1. Subjects with a diagnosis according to NIA/AA criteria of 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 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 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Treatment will not be made available to subjects who have withdrawn from the double-blind study of prior participation prior to completion.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 childbearing potential must continue to use adequate contraception defined as follows (or, if in Italy, agree to avoid pregnancy):
• 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 contraceptives for at least 3 months prior to Baseline
• Vasectomized partner (with the appropriate post-vasectomy documentation of the absence of spermatozoa in the ejaculate)
• 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
• In Germany, subjects must be able to provide their own written informed consent. (see section 13 of the protocol)

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1050
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

1. History of swallowing difficulties (note: study drug should be swallowed whole and MUST NOT be broken, crushed or chewed or dissolved in fluids prior to ingestion)

2. Pregnant or breastfeeding

3. 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

4. Current participation in, or intent to enroll in, a clinical trial of a drug, biologic, device, or medical food

5. In Germany, subjects who meet the following criteria are to be excluded:
• Subjects who reside in a continuous care or assisted living facility if mandated by an order issued by either the judicial or the administrative authorities
• Subjects whose willingness to participate in the clinical trial may be unduly influenced by the expectation (regardless of whether justified) of benefits associated with participation, or of a retaliatory response from family, caregivers, or treating personnel in case of refusal to participate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified