Brain Imaging and Safety Study Evaluating TRx0237 in Subjects With Mild 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: NCT03446001
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Information provided by (Responsible Party):
TauRx Therapeutics Ltd

Brief Summary:
The purpose of this study is to determine the safety and efficacy of TRx0237 8 mg/day in the treatment of subjects with mild Alzheimer's Disease compared to placebo.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: TRx0237 8 mg/day Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, 2-Arm, 6-Month, Brain Imaging and Safety Study of TRx0237 in Subjects With Mild Alzheimer's Disease
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TRx0237 8 mg/day Drug: TRx0237 8 mg/day
Oral TRx0237 4 mg tablet administered twice daily

Placebo Comparator: Placebo Drug: Placebo
Oral placebo tablet administered twice daily

Primary Outcome Measures :
  1. Change in Standardized Uptake Value Ratio based on temporal lobe 18F-fluorodeoxyglucose positron emission tomography (18F-FDG-PET) [ Time Frame: Baseline and 26 weeks ]
  2. Number of participants with serious and non-serious adverse events [ Time Frame: Up to 30 weeks ]
    All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator are to be reported as adverse events

Secondary Outcome Measures :
  1. Change in annualized rate of whole brain atrophy [ Time Frame: Baseline and 6 months ]
    Compare the annualized rate of whole brain atrophy as measured by the Boundary Shift Integral as measured by magnetic resonance imaging (MRI)

  2. Change in annualized rate of atrophy in other brain regions [ Time Frame: Baseline and 6 months ]
    Compare the annualized rate of atrophy of other brain regions (including hippocampus, temporal parietal lobes and lateral ventricular volumes) as measured by MRI

  3. Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) compared to imaging measures [ Time Frame: Baseline, 13 weeks and 26 weeks ]
    Examine associations between the measures of temporal, frontal and parietal lobe SUVR with ADAS-cog11

  4. Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) compared to imaging measures [ Time Frame: Baseline, 13 weeks and 26 weeks ]
    Examine associations between the measures of temporal, frontal and parietal lobe SUVR with ADCS-ADL23

  5. Change from Baseline on Standardized Uptake Value Ratio (using temporal lobe 18F-FDG-PET) based on the presence or absence of Apolipoprotein E4 allele in subjects by or for whom legally acceptable consent is separately provided [ Time Frame: Up to 26 weeks ]

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of all cause dementia and probable Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) score of 20-25 (inclusive) and Clinical Dementia Rating (CDR) of 0.5
  • Age <90 years
  • Females must be surgically sterile, have undergone bilateral tubal occlusion / ligation, be post-menopausal, or use adequate contraception
  • Subject, and/or his/her legal representative(s), consistent with national law, is able to read, understand, and provide written informed consent in the designated language of the study site
  • Has one or more identified adult caregivers who 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; either lives with the subject or sees the subject for ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
  • Must not be taking an acetylcholinesterase inhibitor and/or memantine for at least 90 days at the time of Screening
  • Able to comply with the study procedures in the view of the investigator

Exclusion Criteria:

  • Significant central nervous system disorder other than Alzheimer's Disease
  • Significant intracranial focal or vascular pathology seen on brain MRI scan
  • Prior PET scan by history that is negative for amyloid such that a diagnosis of probable Alzheimer's Disease is not supported
  • Clinical evidence or history of cerebrovascular accident; transient ischemic attack; significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment; other unexplained or recurrent loss of consciousness for ≥15 minutes
  • Epilepsy
  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria met for major depressive disorder; schizophrenia; other psychotic disorders, bipolar disorder; substance (including alcohol) related disorders
  • Metal implants in the head, pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
  • Resides in hospital or moderate to high dependency continuous care facility
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • History of significant hematological abnormality or current acute or chronic clinically significant abnormality
  • Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator
  • Clinically significant cardiovascular disease or abnormal assessments
  • Pre-existing or current signs or symptoms of respiratory failure, e.g., caused by chronic obstructive pulmonary disease, bronchial asthma, lung fibrosis, or other disease
  • Concurrent acute or chronic clinically significant immunologic, hepatobiliary, or endocrine disease and/or other unstable or major disease other than Alzheimer's Disease
  • Diagnosis of cancer within the past 2 years prior to Baseline, unless treatment has resulted in complete freedom from disease for at least 2 years
  • Prior intolerance or hypersensitivity to methylthioninium (MT)-containing drug or methemoglobinemia induced by MT-containing drug, similar organic dyes, or any of the excipients
  • Treatment currently or within 90 days before Baseline with antipsychotics, carbamazepine, primidone, sodium valproate, steroids, or drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses
  • Current or prior participation in any clinical trial of TRx0237; a clinical trial of a product for cognition prior to Screening in which the last dose was received within 120 days prior to Screening unless confirmed to have been randomized to control; or a clinical trial of a drug, biologic, device, or medical food in which the last dose was received within 28 days prior to Baseline

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): NCT03446001

Contact: Marcus Wischik +44 (0)1224 440935

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Sponsors and Collaborators
TauRx Therapeutics Ltd

Responsible Party: TauRx Therapeutics Ltd Identifier: NCT03446001     History of Changes
Other Study ID Numbers: TRx-237-039
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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