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

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ClinicalTrials.gov Identifier: NCT03539380
Expanded Access Status : Available
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

May 15, 2018
May 28, 2018
May 28, 2018
 
TRx0237 for the Treatment of Mild-Moderate Alzheimer's Disease
TRx0237 for the Treatment of Mild-Moderate Alzheimer's Disease: Individual Patient Use
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.
Not Provided
Expanded Access
Individual Patients
Alzheimer Disease
Drug: TRx0237
TRx0237 8 mg/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available

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)
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact: Sotereos Gates, PhD +44 (0) 7771 570707 s.gates@taurx.com
Not Provided
 
 
NCT03539380
TRx-237-040
TauRx Therapeutics Ltd
TauRx Therapeutics Ltd
Not Provided
Not Provided
TauRx Therapeutics Ltd
May 2018