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Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment

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 : April 2, 2020
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 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 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, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRx0237 16 mg/day Drug: TRx0237 16 mg/day
Oral TRx0237 4-mg tablets administered twice daily

Placebo Comparator: Placebo Drug: Placebo
Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily

Experimental: TRx0237 8 mg/day Drug: TRx0237 8 mg/day
Oral TRx0237 4-mg tablet administered twice daily




Primary Outcome Measures :
  1. Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) [ Time Frame: Baseline and 52 weeks ]
    This primary outcome measure will be assessed in the TRx0237 16 mg/day group compared to the placebo group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).

  2. Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) [ Time Frame: Baseline and 52 weeks ]
    This primary outcome measure will be assessed in the TRx0237 16 mg/day group compared to the placebo group. The scores on this scale range from 0 to 78, with higher numbers indicating a better outcome (lower impairment).

  3. Number of study participants with serious and non-serious adverse events [ Time Frame: Up to 52 weeks ]
    This primary outcome measure will be assessed in the TRx0237 16 mg/day group compared to the placebo group. 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 52 weeks ]
    This secondary outcome measure will be assessed in the TRx0237 16 mg/day group compared to the placebo group.

  2. Change in Standardized Uptake Value Ratio (SUVR) based on temporal lobe 18F-fluorodeoxyglucose positron emission tomography (18F-FDG-PET) [ Time Frame: Baseline and 52 weeks ]
    This secondary outcome measure will be assessed in each of the TRx0237 dose groups compared to the placebo group, and restricted to subjects with Clinical Dementia Rating (CDR) 0.5 at Screening.

  3. Change in annualized rate of temporal and parietal lobe atrophy [ Time Frame: Baseline and 52 weeks ]
    This secondary outcome measure will be assessed in each of the TRx0237 dose groups compared to the placebo group.

  4. Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) [ Time Frame: Baseline and 52 weeks ]
    This secondary outcome measure will be assessed in the TRx0237 8 mg/day group compared to the placebo group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).

  5. Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) [ Time Frame: Baseline and 52 weeks ]
    This secondary outcome measure will be assessed in the TRx0237 8 mg/day group compared to the placebo group. The scores on this scale range from 0 to 78, with higher numbers indicating a better outcome (lower impairment).

  6. Change from Open-Label Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) [ Time Frame: 52 weeks and 104 weeks ]
    This secondary outcome measure will be assessed for the open-label period of the study comparing subjects originally randomized to placebo to subjects originally randomized to either dose of TRx0237. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).

  7. Number of study participants with serious and non-serious adverse events [ Time Frame: Up to 104 weeks ]
    This secondary outcome measure will be assessed in the TRx0237 8 mg/day group compared to the placebo group over 52 weeks and for all subjects receiving TRx0237 up to 104 weeks. All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator are to be reported as adverse events.



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 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 16-27 (inclusive)
  • Global Clinical Dementia Rating (CDR) of 0.5 to 2 (if 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, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are 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(s) 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 assessments
  • 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, for example, associated loss of consciousness, skull fracture or persisting cognitive impairment; other unexplained or recurrent loss of consciousness for ≥15 minutes
  • Epilepsy (a single prior seizure >6 months prior to Screening is considered acceptable)
  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 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 significant by the Investigator
  • Clinically significant cardiovascular disease or abnormal electrocardiogram 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 (excluding basal cell carcinoma, squamous cell carcinoma, or prostate carcinoma in situ [Stage 1]) within the past 2 years or a previous (>2 years) diagnosis of cancer that has required any form of intervention or treatment within the past 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 placebo; or a clinical trial of any other investigational 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
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Contact: Tim Earle +441224440905 info@taurx.com

Locations
Hide Hide 155 study locations
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United States, Arizona
Xenoscience Not yet recruiting
Phoenix, Arizona, United States, 85004
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 Clinical Research Not yet recruiting
Little Rock, Arkansas, United States, 72209
United States, California
CITrials Not yet recruiting
Bellflower, California, United States, 90706
ATP Clinical Research, Inc. Active, not recruiting
Costa Mesa, California, United States, 92626
Fullerton Neurology and Headache Center Terminated
Fullerton, California, United States, 92835
Behavioral Research Specialist, LLC Active, not recruiting
Glendale, California, United States, 91206
Paradigm Research Recruiting
La Mesa, California, United States, 91942
Senior Clinical Trials, Inc. Recruiting
Laguna Hills, California, United States, 92653
Hoag Memorial Hospital Presbyterian Not yet recruiting
Newport Beach, California, United States, 92663
Excell Research, Inc. Recruiting
Oceanside, California, United States, 92056
Sutter Institute for Medical Research Not yet recruiting
Sacramento, California, United States, 95816
Sharp Mesa Vista Hospital Not yet recruiting
San Diego, California, United States, 92123
HB Clinical Trials Inc. Not yet recruiting
Santa Ana, California, United States, 92704
CITrials Not yet recruiting
Santa Ana, California, United States, 92705
Syrentis Clinical Research Not yet recruiting
Santa Ana, California, United States, 92705
California Neuroscience Medical Group Not yet recruiting
Sherman Oaks, California, United States, 91403
United States, Connecticut
Yale University Not yet recruiting
Fairfield, Connecticut, United States, 06824
Coastal Connecticut Research, LCC Not yet recruiting
New London, Connecticut, United States, 06320
United States, Florida
Visionary Investigators Network Not yet recruiting
Aventura, Florida, United States, 33180
Boca Raton Regional Hospital, Marcus Neuroscience Institute Not yet recruiting
Boca Raton, Florida, United States, 33486
Finlay Medical Research Not yet recruiting
Green Acres, Florida, United States, 33467
MD Clinical Not yet recruiting
Hallandale Beach, Florida, United States, 33009
Indago Research & Health Center, Inc. Not yet recruiting
Hialeah, Florida, United States, 33012
Merrit Island Medical Research Not yet recruiting
Merritt Island, Florida, United States, 32952
Health Care Family Rehab and Research Recruiting
Miami, Florida, United States, 33015
Homestead Associates in Research, Inc. Not yet recruiting
Miami, Florida, United States, 33032
Optimus Clinical Research Recruiting
Miami, Florida, United States, 33125
Biomed Research Institute, Inc Not yet recruiting
Miami, Florida, United States, 33126
Finlay Medical Research Not yet recruiting
Miami, Florida, United States, 33126
CCM Clinical Research Group Recruiting
Miami, Florida, United States, 33133
Advance Medical Research Center Not yet recruiting
Miami, Florida, United States, 33135
Vitae Research Center, LLC Not yet recruiting
Miami, Florida, United States, 33135
L&C Professional Medical Research Institute Terminated
Miami, Florida, United States, 33144
Allied Biomedical Research Institute Not yet recruiting
Miami, Florida, United States, 33155
Future Care Solution, LLC Not yet recruiting
Miami, Florida, United States, 33165
Florida International Research Center Active, not recruiting
Miami, Florida, United States, 33173
Miami Dade Medical Research Institute, LLC Recruiting
Miami, Florida, United States, 33176
Visionary Investigators Network Not yet recruiting
Miami, Florida, United States, 33176
Novel Clinical Research Center Withdrawn
Miami, Florida, United States, 33186
Renstar Medical Research Not yet recruiting
Ocala, Florida, United States, 34470
Bioclinica Research Not yet recruiting
Ocala, Florida, United States, 34471
Sensible Healthcare Recruiting
Ocoee, Florida, United States, 34761
Bioclinica Research Not yet recruiting
Orlando, Florida, United States, 32806
Combined Research Orlando Phase I-IV Not yet recruiting
Orlando, Florida, United States, 32807
IMIC Inc Not yet recruiting
Palmetto Bay, Florida, United States, 33157
Emerald Coast Center for Neurological Disorders Recruiting
Pensacola, Florida, United States, 32504
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
The Roskamp Institute, Inc. Recruiting
Sarasota, Florida, United States, 34243
Meridien Research Withdrawn
Spring Hill, Florida, United States, 34609
Stedman Clinical Trials Recruiting
Tampa, Florida, United States, 33613
Alzheimer's Research and Treatment Center Recruiting
Wellington, Florida, United States, 33414
United States, Georgia
NeuroStudies.net, LLC Active, not recruiting
Decatur, Georgia, United States, 30033
Georgia Neurology and Sleep Medicine Associates Active, not recruiting
Suwanee, Georgia, United States, 30024
United States, Idaho
Advanced Clinical Research Withdrawn
Boise, Idaho, United States, 83642
United States, Indiana
Josephson Wallack Munshower Neurology P.C. Not yet recruiting
Indianapolis, Indiana, United States, 46256
United States, Kansas
Heartland Research Associates Withdrawn
Newton, Kansas, United States, 67114
United States, New Jersey
Advanced Memory Research of NJ PC Not yet recruiting
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County, PA Not yet recruiting
West Long Branch, New Jersey, United States, 07764
United States, New York
Albany Medical College Not yet recruiting
Albany, New York, United States, 12208
SPRI Clinical Trials Not yet recruiting
Brooklyn, New York, United States, 11235
University at Buffalo Neurology Not yet recruiting
Buffalo, New York, United States, 14203
New York University Not yet recruiting
New York, New York, United States, 10016
Richmond Behavioral Associates Not yet recruiting
Staten Island, New York, United States, 10312
United States, North Carolina
Alzheimer's Memory Center Not yet recruiting
Charlotte, North Carolina, United States, 28270
Wake Research Associates Active, not recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Ohio Clinical Research Partners, LLC Not yet recruiting
Canton, Ohio, United States, 44718
Valley Medical Research Recruiting
Centerville, Ohio, United States, 45459
The Lindner Research Center Active, not recruiting
Cincinnati, Ohio, United States, 45219
Neurology Diagnostics Inc. Not yet recruiting
Dayton, Ohio, United States, 45459
Neuro-Behavioral Clinical Research Not yet recruiting
North Canton, Ohio, United States, 44321
University of Cincinnati Physicians Not yet recruiting
West Chester, Ohio, United States, 45069
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73106
Tulsa Clinical Research LLC Not yet recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Neural Net Research Not yet recruiting
Portland, Oregon, United States, 97225
United States, South Carolina
CBRI - Roper Hospital Not yet recruiting
Charleston, South Carolina, United States, 29414
Coastal Neurology Not yet recruiting
Port Royal, South Carolina, United States, 29935
United States, Tennessee
NIIP at Quillen College of Medicine Not yet recruiting
Johnson City, Tennessee, United States, 37604
United States, Texas
Texas Neurology, P. A. Not yet recruiting
Dallas, Texas, United States, 75214
Texas Center for Drug Development, Inc. Terminated
Houston, Texas, United States, 77081
University of Texas Health Science Center Not yet recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Re:Cognition Health Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Virginia Mason Medical Center Active, not recruiting
Seattle, Washington, United States, 98101
Universal Research Group, LLC Not yet recruiting
Tacoma, Washington, United States, 98405
Belgium
Cliniques Universitaires Saint-Luc Not yet recruiting
Bruxelles, Belgium, 1200
UZ Antwerpen Not yet recruiting
Edegem, Belgium, 2650
Virga Jesse Ziekenhuis Not yet recruiting
Limbourg, Belgium, 3500
Canada, British Columbia
Okanagan Clinical Trials, Ltd. Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Medical Arts Health Research Group Not yet recruiting
West Vancouver, British Columbia, Canada, V7T 1C5
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
Memory Clinic (Ottawa) Not yet recruiting
Ottawa, Ontario, Canada, K1Z 1G3
Canada, Quebec
Clinique Mémoire 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 Not yet recruiting
Bron, France, 69677
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
Hopital Laennec - CHU de Nantes Not yet recruiting
Nantes, France, 44093
CMRR - CHU Pontchaillou Not yet recruiting
Rennes, France, 35009
Centre d'Investigation Clinique Not yet recruiting
Strasbourg, France, 67200
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
IRCCS 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
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, 00199
IRCCS Fondazione Santa Lucia Not yet recruiting
Rome, Italy, 00179
Policlinico Santa Maria alle Scotte Not yet recruiting
Siena, Italy, 53100
Clinica Neurologica Santa Maria della Misericordia Not yet recruiting
Udine, Italy, 33100
Poland
Podlaskie Centrum Psychogeriatrii Not yet recruiting
Bialystok, Poland, 15-756
Centrum Medyczne NEUROMED 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
Indywidualna Praktyka Lekarska Not yet recruiting
Lublin, Poland, 20-582
NZOZ Neuro-Kard 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
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Hospital General de Catalunya Not yet recruiting
Barcelona, Spain, 08190
Hospitales de Madrid Not yet recruiting
Madrid, Spain, 28015
Fundacion para la Investigacion Biomedica Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hospital Universitario QuironSalud Not yet recruiting
Madrid, Spain, 28223
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 Mutua Terrassa Not yet recruiting
Terrassa, Spain, 08221
Hospital Universitario Doctor Peset Not yet recruiting
Valencia, Spain, 46017
United Kingdom
Royall Cornhill Hospital Not yet recruiting
Aberdeen, United Kingdom, AB25 2ZH
Birmingham & Solihull Mental Health NHS Foundation Not yet recruiting
Birmingham, United Kingdom, B15 2SY
Re:Cognition Health Active, not recruiting
Birmingham, United Kingdom, B16 8LT
Dorset HealthCare University NHS Foundation Trust Not yet recruiting
Bournemouth, United Kingdom, BH1 4JQ
2gether Research Not yet recruiting
Cheltenham, United Kingdom, GL53 9DZ
NHS Tayside, Ninewells Hospital and Medical School Not yet recruiting
Dundee, United Kingdom, DD1 9SY
Glasgow Memory Clinic Ltd Not yet recruiting
Glasgow, United Kingdom, G20 0XA
Queen Elizabeth University Hospital Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Re:Cognition Health Active, not recruiting
Guildford, United Kingdom, GU2 7YD
West London NHS Trust Not yet recruiting
Isleworth, United Kingdom, TW7 6FY
South London & Maudsley NHS Trust Not yet recruiting
London, United Kingdom, SE5 8AF
Re:Cognition Health - Central London Active, not recruiting
London, United Kingdom, W1G 9JF
St. Pancras Clinical Research Not yet recruiting
London, United Kingdom, WC1X 8QD
Re:Cognition Health Active, not recruiting
Plymouth, United Kingdom, PL6 8BT
Sheffield Health & Social Care NHS FT Not yet recruiting
Sheffield, United Kingdom, S5 7JT
Moorgreen Hospital Not yet recruiting
Southampton, United Kingdom, SO30 3JB
St Georges Hospital Not yet recruiting
Stafford, United Kingdom, ST16 3AG
Sponsors and Collaborators
TauRx Therapeutics Ltd
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Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT03446001    
Other Study ID Numbers: TRx-237-039
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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