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TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
TRx0237
Sponsored by
TauRx Therapeutics Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Alzheimer Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Early (encompassing Mild Cognitive Impairment) or mild to moderate Alzheimer's disease, as confirmed by a cognitive assessment
  • Clinical benefit of continued access to TRx0237 is expected to outweigh any perceived risk
  • Ability to travel to the named clinic for regularly scheduled visits.
  • The patient and/or his/her legal representative have been informed of the potential risks and obligations and have given written informed consent for continued treatment consistent with local requirements.
  • Not participating in a clinical trial of another investigational drug.
  • Has one (or more) identified adult study partner who either lives with the subject or has sufficient contact to provide assessment of changes in subject behavior and function over time and 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
  • A female patient of child-bearing potential must use adequate birth control (as defined by the protocol) for at least 90 days before beginning treatment and agree to continue its use whilst on treatment and for 30 days after the last dose of TRx0237.

Exclusion Criteria:

  • Swallowing difficulties which prevent taking the medication whole as instructed.
  • Unable to comply with this study protocol or has health concerns that may increase risk, in the opinion of the treating physician
  • Enrolled in a previous TRx0237 clinical trial and either did not complete the clinical trial, had a significant treatment-related adverse event that could cause an undue risk, or progressed to severe Alzheimer's disease
  • Current use of acetylcholinesterase inhibitors and/or memantine (use is permitted prior to enrollment and is to be discontinued under the guidance of the treating physician in order to enter this study)
  • Use of drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine and related antimalarials)
  • Use of clozapine
  • Clinically significant cardiovascular disease
  • Clinically significant respiratory failure
  • History of clinically significant hematological abnormality or hemoglobin value (confirmed upon repeat) below age/sex appropriate laboratory lower limit of normal
  • Creatinine clearance <30 mL/min
  • Clinically significant alanine transaminase (3×the upper limit of normal [ULN]) and/or bilirubin (2×ULN) values

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2018
    Last Updated
    October 4, 2023
    Sponsor
    TauRx Therapeutics Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03539380
    Brief Title
    TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease
    Official Title
    TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease: Intermediate-Size Patient Population
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TauRx Therapeutics Ltd

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access program (EAP) for eligible participants. This program is designed to provide continued access to TRx0237 to individual patients with early and mild-moderate Alzheimer's disease who do not qualify for participation in an ongoing clinical trial. Eligible participants must have previously completed participation in a clinical trial of TRx0237 conducted by TauRx or have previously taken TRx0237 in a compassionate use program, among other criteria. Patients will be considered where a physician can demonstrate clinical benefit for a patient not meeting these criteria; in these cases, TauRx will consider participation of the patient on a case-by-case basis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    TRx0237
    Intervention Description
    Starting dose of TRx0237 16 mg/day (unless enrolled under earlier version of protocol and are on an established dose), with flexible dosing after 3 months (4-16 mg/day)

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Early (encompassing Mild Cognitive Impairment) or mild to moderate Alzheimer's disease, as confirmed by a cognitive assessment Clinical benefit of continued access to TRx0237 is expected to outweigh any perceived risk Ability to travel to the named clinic for regularly scheduled visits. The patient and/or his/her legal representative have been informed of the potential risks and obligations and have given written informed consent for continued treatment consistent with local requirements. Not participating in a clinical trial of another investigational drug. Has one (or more) identified adult study partner who either lives with the subject or has sufficient contact to provide assessment of changes in subject behavior and function over time and 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 A female patient of child-bearing potential must use adequate birth control (as defined by the protocol) for at least 90 days before beginning treatment and agree to continue its use whilst on treatment and for 30 days after the last dose of TRx0237. Exclusion Criteria: Swallowing difficulties which prevent taking the medication whole as instructed. Unable to comply with this study protocol or has health concerns that may increase risk, in the opinion of the treating physician Enrolled in a previous TRx0237 clinical trial and either did not complete the clinical trial, had a significant treatment-related adverse event that could cause an undue risk, or progressed to severe Alzheimer's disease Use of drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine and related antimalarials) Use of clozapine Clinically significant cardiovascular disease Clinically significant respiratory failure History of clinically significant hematological abnormality or hemoglobin value (confirmed upon repeat) below age/sex appropriate laboratory lower limit of normal Creatinine clearance <15 mL/min Clinically significant alanine transaminase (3×the upper limit of normal [ULN]) and/or bilirubin (2×ULN) values
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sotereos Gates, PhD
    Phone
    +44 (0) 7771 570707
    Email
    s.gates@taurx.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diane Downie, PhD
    Email
    d.downie@taurx.com

    12. IPD Sharing Statement

    Links:
    URL
    http://taurx.com
    Description
    Sponsor website

    Learn more about this trial

    TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease

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