Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03446001
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : May 3, 2019
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

Layout table for study information
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 : December 2020
Estimated Study Completion Date : December 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). Each item is scored and summed for a total Composite Scale score of 0-49, with a higher score indicative of better cognitive/functional performance.

  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-cog13 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-cog13

  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. 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). Each item is scored and summed for a total Composite Scale score of 0-49, with a higher score indicative of better cognitive/functional performance.

  7. Change in Composite Scale compared to imaging measures [ Time Frame: Baseline and 39 weeks ]
    Examine associations between the measures of temporal, frontal, and parietal lobe SUVR with the Composite Scale. 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). Each item is scored and summed for a total Composite Scale score of 0-49, with a higher score indicative of better cognitive/functional performance.

  8. 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

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.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Marcus Wischik +44 (0)1224 440935 info@taurx.com

  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Hope Research Institute Not yet recruiting
Peoria, Arizona, United States, 85381
Hope Research Institute Not yet recruiting
Phoenix, Arizona, United States, 85018
Arizona Research Center Not yet recruiting
Phoenix, Arizona, United States, 85053
Imaging Endpoints Research Not yet recruiting
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Atria Research Not yet recruiting
Little Rock, Arkansas, United States, 72209
United States, California
ATP Clinical Research, Inc. Recruiting
Costa Mesa, California, United States, 92626
Fullerton Neurology and Headache Center Recruiting
Fullerton, California, United States, 92835
Behavioral Research Specialist, LLC Not yet recruiting
Glendale, California, United States, 91206
Fort Walton Beach Medical Center Recruiting
Laguna Hills, California, United States, 92653
Hoag Memorial Hospital Presbyterian Not yet recruiting
Newport Beach, California, United States, 92663
Excell Research, Inc. Not yet recruiting
Oceanside, California, United States, 92056
CITrials Not yet recruiting
Riverside, California, United States, 92506
Sutter Institute for Medical Research Not yet recruiting
Sacramento, California, United States, 95816
Paradigm Research Not yet recruiting
San Diego, California, United States, 92117
Sharp Mesa Vista Hospital Not yet recruiting
San Diego, California, United States, 92123
CITrials Not yet recruiting
Santa Ana, California, United States, 92705
Syrentis Clinical Research Not yet recruiting
Santa Ana, California, United States, 92705
United States, Florida
Boca Raton Regional Hospital, Marcus Neuroscience Institute Not yet recruiting
Boca Raton, Florida, United States, 33486
MD Clinical Not yet recruiting
Hallandale Beach, Florida, United States, 33009
Indago Research & Health Center, Inc. Not yet recruiting
Hialeah, Florida, United States, 33012
Alzheimers Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Wein Center Memory Disorder Clinic Not yet recruiting
Miami Beach, Florida, United States, 33140
Homestead Associates in Research, Inc. Not yet recruiting
Miami, Florida, United States, 33032
CCM Clinical Research Group Not yet recruiting
Miami, Florida, United States, 33133
Advance Medical Research Center Not yet recruiting
Miami, Florida, United States, 33135
L&C Professional Medical Research Institute Not yet recruiting
Miami, Florida, United States, 33144
Allied Biomedical Research Institute Not yet recruiting
Miami, Florida, United States, 33155
Allied Clinical Trials, Inc. Not yet recruiting
Miami, Florida, United States, 33156
Cordova Research Institute Not yet recruiting
Miami, Florida, United States, 33165
Future Care Solution, LLC Not yet recruiting
Miami, Florida, United States, 33165
Florida International Research Center Not yet recruiting
Miami, Florida, United States, 33173
Advanced Medical Research Institute Recruiting
Miami, Florida, United States, 33174
Miami Dade Medical Research Institute, LLC Recruiting
Miami, Florida, United States, 33176
Novel Clinical Research Center Recruiting
Miami, Florida, United States, 33186
Sensible Healthcare, LLC Not yet recruiting
Ocoee, Florida, United States, 34761
Clinical Neuroscience Solutions, Inc Not yet recruiting
Orlando, Florida, United States, 32801
Compass Research LLC Not yet recruiting
Orlando, Florida, United States, 32806
Combined Research Orlando Phase I-IV Not yet recruiting
Orlando, Florida, United States, 32807
Health Care Family Rehab and Research Recruiting
Pembroke Pines, Florida, United States, 33024
Emerald Coast Center for Neurological Disorders Not yet recruiting
Pensacola, Florida, United States, 32514
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
The Roskamp Institute, Inc. Not yet recruiting
Sarasota, Florida, United States, 34243
Meridien Research Recruiting
Spring Hill, Florida, United States, 34609
Stedman Clinical Trials Not yet recruiting
Tampa, Florida, United States, 33613
Renstar Medical Research Not yet recruiting
Wesley Chapel, Florida, United States, 33544
United States, Georgia
NeuroStudies.net, LLC Recruiting
Decatur, Georgia, United States, 30033
GA Neurology and Sleep Medicine Not yet recruiting
Suwanee, Georgia, United States, 30024
United States, Idaho
Advanced Clinical Research Recruiting
Boise, Idaho, United States, 83642
United States, Illinois
Healthcare Research Network II Not yet recruiting
Flossmoor, Illinois, United States, 60422
United States, Kansas
Heartland Research Associates Recruiting
Newton, Kansas, United States, 67114
United States, Louisiana
Ochsner Health System Not yet recruiting
New Orleans, Louisiana, United States, 70121
United States, New Jersey
Neurology Specialists of Monmouth County, PA Not yet recruiting
West Long Branch, New Jersey, United States, 07764
United States, New York
University at Buffalo Not yet recruiting
Buffalo, New York, United States, 14203
Adirondack Medical Research Center Not yet recruiting
Glens Falls, New York, United States, 12801
New York University Not yet recruiting
New York, New York, United States, 10016
United States, North Carolina
Alzheimer's Memory Center Not yet recruiting
Charlotte, North Carolina, United States, 28270
Wake Research Associates Not yet recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Insight Clinical Trials LLC Not yet recruiting
Beachwood, Ohio, United States, 44122
Ohio Clinical Research Partners Not yet recruiting
Canton, Ohio, United States, 44718
Valley Medical Research Not yet recruiting
Centerville, Ohio, United States, 45459
The Carl and Edyth Lindner Research Center Recruiting
Cincinnati, Ohio, United States, 45219
Rapid Medical Research, Inc. Recruiting
Cleveland, Ohio, United States, 44122
University of Cincinnati Physicians Not yet recruiting
West Chester, Ohio, United States, 45069
United States, Oklahoma
IPS Research Company Not yet recruiting
Oklahoma City, Oklahoma, United States, 73103
Red River Medical Research Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Keystone Clinical Studies, LLC Not yet recruiting
Norristown, Pennsylvania, United States, 19403
United States, Tennessee
NIIP at Quillen College of Medicine Not yet recruiting
Johnson City, Tennessee, United States, 37604
United States, Texas
Texas Neurology Not yet recruiting
Dallas, Texas, United States, 75214
Texas Center for Drug Development, Inc. Recruiting
Houston, Texas, United States, 77081
University of Texas Health Sciences Not yet recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Center for Alzheimer's Care, Imaging and Research (CACIR) Not yet recruiting
Salt Lake City, Utah, United States, 84108
Advanced Clinical Research Not yet recruiting
West Jordan, Utah, United States, 84088
United States, Virginia
Re:Cognition Health Not yet recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Virginia Mason Hospital Not yet recruiting
Seattle, Washington, United States, 98101
Universal Research Group, LLC Not yet recruiting
Tacoma, Washington, United States, 98405
Belgium
UZ Antwerpen Not yet recruiting
Edegem, Belgium, 2650
Virga Jesse Ziekenhuis Not yet recruiting
Hasselt, Belgium, 3500
Canada, British Columbia
Okanagan Clinical Trials, Ltd. Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Canada, Nova Scotia
True North Clinical Research - Halifax Not yet recruiting
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Not yet recruiting
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
JBN Medical Diagnostic Service Not yet recruiting
Burlington, Ontario, Canada, L7M 4Y1
Canada, Quebec
Clinique de la Mémorie de l'Outaouais Not yet recruiting
Gatineau, Quebec, Canada, J8T 8J1
McGill University Faculty of Medicine - McGill Centre for Studies in Aging Not yet recruiting
Verdun, Quebec, Canada, H4H 1R3
Canada
Alpha Recherche Clinique Not yet recruiting
Québec, Canada, G3K 2P8
France
CHU Bordeaux Not yet recruiting
Bordeaux, France, 33000
Hôpital neurologique - Hospices Civils de Lyon Not yet recruiting
Bron, France, 69677
CHU de Caen Not yet recruiting
Caen, France, 14033
CHU de Limoges Not yet recruiting
Limoges, France, 87000
Timone Adults Hospital Not yet recruiting
Marseille, France, 13385
Guidechauliac Hospital Not yet recruiting
Montpellier, France, 34295
Hospital Guillaume et Rena Laannec Not yet recruiting
Nantes, France, 44093
Geriatrics department, Hôpital de Jour - Pavillon Saint-François Not yet recruiting
Strasbourg, France, 67000
CRC Gerontopole Cite de la Sante Not yet recruiting
Toulouse, France, 31059
Hopital des Charpennes Not yet recruiting
Villeurbanne, France, 69100
Italy
IRCCS Centro S. Giovanni di Dio Fatebenefratelli Not yet recruiting
Brescia, Italy, 25125
Foundation Institute G.Giglio Not yet recruiting
Cefalù, Italy, 90015
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Not yet recruiting
Milano, Italy, 20122
Azienda Ospedaliera San Gerardo - Clinica Neurologica Not yet recruiting
Monza, Italy, 20900
Istituto neurologico Casimiro Mondino, IRCCS Not yet recruiting
Pavia, Italy, 27100
University of Perugia, Ospedale S.M. della Misericordia Not yet recruiting
Perugia, Italy, 06156
A.O.U. Pisa Not yet recruiting
Pisa, Italy, 56126
IRCCS Fondazione Santa Lucia Not yet recruiting
Roma, Italy, 00179
Ospedale San Giovanni Calibita Fatebenefratelli Not yet recruiting
Roma, Italy, 00186
Azienda Ospedaliera Sant Andrea Not yet recruiting
Roma, Italy, 00189
A.Gemelli Not yet recruiting
Roma, Italy
Policlinico Santa Maria alle Scotte Not yet recruiting
Siena, Italy, 53100
Clinica Neurologica e Neuroriabilitazione Not yet recruiting
Udine, Italy, 33100
Poland
Podlaskie Centrum Psychogeriatrii Not yet recruiting
Bialystok, Poland, 15-756
Centrum Medyczne NEUROMED Not yet recruiting
Bydgoszcz, Poland, 85-163
Uniwersyteckie Centrum Kliniczne Not yet recruiting
Gdansk, Poland, 80-952
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS Not yet recruiting
Katowice, Poland, 40-123
Centrum Zdrowia Psychicznego Biomed Not yet recruiting
Kielce, Poland, 25-411
Samodzielny Publiczny Szpital Kliniczny Not yet recruiting
Lublin, Poland, 20-090
NZOZ Neuro-Kard Not yet recruiting
Poznań, Poland, 61-853
Poradnia Neurologiczna z Poradnia Diagnostyki i Leczenia Zaburzen Pamieci Not yet recruiting
Szczecin, Poland, 70-111
Centrum Medyczne NeuroProtect Not yet recruiting
Warszawa, Poland, 01-697
Spain
Instituto Internacional de Neurociencias Aplicadas Not yet recruiting
Barcelona, Spain, 08006
Hospital General de Catalunya Not yet recruiting
Barcelona, Spain, 08190
Fundacion para la Investigacion Biomedica Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Centro de salud de San Juan, Unidad de Investigación Neurociencias Not yet recruiting
Salamanca, Spain, 37005
Hospital Virgen de la Macarena Not yet recruiting
Sevilla, Spain, 41009
Hospital Universitario Doctor Peset Not yet recruiting
Valencia, Spain, 46017
United Kingdom
Birmingham & Solihull Mental Health NHS Foundation Not yet recruiting
Birmingham, West Midlands, United Kingdom, B15 2SY
Re:Cognition Health Not yet recruiting
Birmingham, United Kingdom, B16 8LT
2gether Research Not yet recruiting
Cheltenham, United Kingdom, GL53 9DZ
Glasgow Memory Clinic Ltd Not yet recruiting
Glasgow, United Kingdom, G20 0XA
Re:Cognition Health Not yet recruiting
Guildford, United Kingdom, GU2 7YD
Re:Cognition Health - Central London Not yet recruiting
London, United Kingdom, W1G 9JF
St. Pancras Clinical Research Not yet recruiting
London, United Kingdom
Northamptonshire Healthcare NH Not yet recruiting
Northampton, United Kingdom, NN5 6UD
Re:Cognition Health Not yet recruiting
Plymouth, United Kingdom, PL6 8BT
West London Mental Health NHS Trust Not yet recruiting
Southall, United Kingdom, UB1 3EU
Moorgreen Hospital Not yet recruiting
Southampton, United Kingdom, S030 3JB
St Georges Hospital Not yet recruiting
Stafford, United Kingdom, ST16 3AG
Sponsors and Collaborators
TauRx Therapeutics Ltd

Layout table for additonal information
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: May 3, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for 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