TRx0237 for the Treatment of 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. Identifier: NCT03539380
Expanded Access Status : Available
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
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 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, among other criteria.

Condition or disease Intervention/treatment
Alzheimer Disease Drug: TRx0237

Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: TRx0237 for the Treatment of Mild-Moderate Alzheimer's Disease: Individual Patient Use

Intervention Details:
  • Drug: TRx0237
    TRx0237 8 mg/day

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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
  • The patient has the ability to travel to the named clinic for regularly scheduled visits.
  • The patient and/or his/her legal guardian have been informed of the potential risks and obligations and have given written informed consent for continued treatment consistent with local requirements.
  • The patient is not participating in a clinical trial of another investigational drug.
  • 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.
  • Patients, who in the opinion of the treating physician, are unable to comply with this study protocol or have health concerns that may increase risk.
  • Patients who enrolled in a previous TRx0237 clinical trial and either did not complete the clinical trial or had a significant treatment-related adverse event that could cause an undue risk
  • Current use of acetylcholinesterase inhibitors and/or memantine
  • 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 or olanzapine
  • Clinically significant respiratory failure (e.g., caused by chronic obstructive pulmonary disease, bronchial asthma, lung fibrosis, or other disease)
  • History of clinically significant hematological abnormality (including hemoglobinopathy, myelodysplastic syndrome, hemolytic anemia, or splenectomy) 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
  • Clinically significant cardiovascular disease (e.g., acute coronary syndrome or symptoms consistent with angina pectoris, signs or symptoms of clinical heart failure, atrial fibrillation that is not currently controlled, QTcF [QT corrected for heart rate using Fridericia's formula] of >460 msec in males or >470 msec in females, poorly controlled hypertension, tachycardia, or bradycardia)

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 identifier (NCT number): NCT03539380

Contact: Sotereos Gates, PhD +44 (0) 7771 570707

Sponsors and Collaborators
TauRx Therapeutics Ltd

Responsible Party: TauRx Therapeutics Ltd Identifier: NCT03539380     History of Changes
Other Study ID Numbers: TRx-237-040
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action