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
About this trial
This is an expanded access trial for Alzheimer Disease
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
- 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
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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