Alzheimer DiseaseNCT03539380
TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease
A study testing TRx0237 in people with Alzheimer Disease, run by TauRx Therapeutics Ltd.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- TRx0237
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
Diane Downie, PhD contact
About this study
Official title: TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease: Intermediate-Size Patient Population
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.
- Conditions
- Alzheimer Disease
- Being tested
- TRx0237
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRx0237Drug
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- TauRx Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539380
- Sponsor's protocol ID
- TRx-237-040
- Status last verified
- Sep 2024
- First submitted
- 15 May 2018
- Last updated
- 27 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease: Intermediate-Size Patient Population
- ClinicalTrials.gov ID
- NCT03539380
- Acronym / sponsor ID
- TRx-237-040
- Conditions
- Alzheimer Disease
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- TauRx Therapeutics LtdIndustry (pharma, biotech, devices)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRx0237Starting 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) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Sponsor websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Downie, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing TRx0237 in people with Alzheimer Disease, run by TauRx Therapeutics Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sotereos Gates, PhD (+44 (0) 7771 570707, s.gates@taurx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.