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Safety and Efficacy of TRx0237 in Subjects With Early Alzheimer's Disease (LUCIDITY)

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ClinicalTrials.gov Identifier: NCT03446001
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : September 7, 2018
Sponsor:
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 and 16 mg/day in the treatment of subjects with early Alzheimer's Disease compared to placebo.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: TRx0237 8 mg/day Drug: Placebo Drug: TRx0237 16 mg/day Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 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, Three-Arm, 9-Month, Brain Imaging and Safety and Efficacy Study of TRx0237 in Subjects With Early Alzheimer's Disease
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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 tablets administered twice daily

Experimental: TRx0237 16 mg/day Drug: TRx0237 16 mg/day
Oral TRx0237 4 mg tablets administered twice daily




Primary Outcome Measures :
  1. Change in Standardized Uptake Value Ratio (SUVR) based on temporal lobe 18F-fluorodeoxyglucose positron emission tomography (18F-FDG-PET) [ Time Frame: Baseline and 39 weeks ]
  2. Change in composite cognitive/functional scale ("Composite Scale") [ Time Frame: Baseline and 39 weeks ]
    The Composite Scale is based on a subset of items selected from the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) and the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)

  3. Number of participants with serious and non-serious adverse events [ Time Frame: Up to 39 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 SUVR based on frontal and parietal lobe 18F-FDG-PET [ Time Frame: Baseline and 39 weeks ]
  2. Change in annualized rate of temporal and parietal lobe atrophy [ Time Frame: Baseline and 39 weeks ]
    Compare the annualized rate of temporal and parietal lobe atrophy as measured by the Boundary Shift Integral as measured by brain magnetic resonance imaging (MRI)

  3. Change in annualized rate of atrophy in other brain regions [ Time Frame: Baseline and 39 weeks ]
    Compare the annualized rate of atrophy of other brain regions (including hippocampus, whole brain, and lateral ventricular volumes) as measured by MRI

  4. Change in ADAS-cog11 compared to imaging measures [ Time Frame: Baseline, 13 weeks, 26 weeks, and 39 weeks ]
    Examine associations between the measures of temporal, frontal and parietal lobe 18F-FDG-PET change in SUVR and temporal and parietal lobe atrophy (and other MRI brain regions) with ADAS-cog11

  5. Change in ADCS-ADL23 compared to imaging measures [ Time Frame: Baseline, 13 weeks, 26 weeks, and 39 weeks ]
    Examine associations between the measures of temporal, frontal and parietal lobe 18F-FDG-PET change in SUVR and temporal and parietal lobe atrophy (and other MRI brain regions) with ADCS-ADL23

  6. Change in Composite Scale compared to imaging measures [ Time Frame: Baseline, 13 weeks, 26 weeks, and 39 weeks ]
    Examine associations between the measures of temporal and parietal lobe atrophy (and other MRI brain regions) with the Composite Scale

  7. Change in SUVR (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 39 weeks ]


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Diagnosis of early Alzheimer's Disease (AD), encompassing probable AD and mild cognitive impairment due to AD (MCI-AD) based on the 2011 National Institute on Aging and Alzheimer's Association (NIA/AA) criteria
  • Documented PET scan that is positive for amyloid
  • Mini-Mental State Examination (MMSE) score of 20-27 (inclusive)
  • Global Clinical Dementia Rating (CDR) of 0.5 (including a score of >0 in one of the functional domains: Community Affairs, Home and Hobbies, or Personal Care)
  • Age <90 years
  • Females must be surgically sterile, have undergone bilateral tubal occlusion / ligation, be post-menopausal, or use adequate contraception
  • Subject, 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 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; and is able to verify daily compliance with study drug
  • Must not be taking an acetylcholinesterase inhibitor and/or memantine for at least 60 days at the time of the Baseline 18F-FDG-PET
  • Able to comply with the study procedures in the view of the investigator

Exclusion Criteria:

  • Significant central nervous system disorder other than probable AD or MCI-AD
  • Significant intracranial focal or vascular pathology seen on brain MRI scan that would lead to a diagnosis other than probable AD or MCI-AD
  • 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
  • Any physical disability that would prevent completion of study procedures or assessments
  • 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
  • Concurrent acute or chronic clinically significant immunologic, hepatobiliary, or endocrine disease and/or other unstable or major disease other than probable AD or MCI-AD
  • 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 Souvenaid®, clozapine, carbamazepine, primidone, valproate, 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 Baseline in which the last dose was received within 90 days prior to Baseline 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 ClinicalTrials.gov identifier (NCT number): NCT03446001


Contacts
Contact: Marcus Wischik +44 (0)1224 440935 info@taurx.com

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Sponsors and Collaborators
TauRx Therapeutics Ltd

Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT03446001     History of Changes
Other Study ID Numbers: TRx-237-039
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action