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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539380
Expanded Access Status : Available
First Posted : May 29, 2018
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

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.

Condition or disease Intervention/treatment
Alzheimer Disease Drug: TRx0237

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's Disease: Individual Patient Use



Intervention Details:
  • Drug: TRx0237
    TRx0237 8 mg/day, with flexible dosing after 3 months (4-20 mg/day)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539380


Contacts
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Contact: Sotereos Gates, PhD +44 (0) 7771 570707 s.gates@taurx.com
Contact: Diane Downie, PhD d.downie@taurx.com

Sponsors and Collaborators
TauRx Therapeutics Ltd
Additional Information:
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Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT03539380    
Other Study ID Numbers: TRx-237-040
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders