Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
1 other identifier
interventional
891
16 countries
121
Brief Summary
The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild to moderate Alzheimer's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2013
Typical duration for phase_3
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedMarch 14, 2018
March 1, 2018
2.8 years
September 14, 2012
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
65 weeks
Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
65 weeks
Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
Safety parameters include adverse events, vital signs, methemoglobin and oxygen saturation, physical and neurological examinations, laboratory tests (hematology, serum chemistry, and urinalysis), electrocardiograms, potential for suicide and self-harm, brain magnetic resonance imaging (MRI), and potential for serotonin toxicity
65 weeks
Secondary Outcomes (3)
Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
65 weeks
Change from Baseline on Mini-Mental Status Examination (MMSE)
65 weeks
Change in expected decline of whole brain volume as measured by brain MRI
39 weeks and 65 weeks
Other Outcomes (5)
Reduction in glucose uptake decline in the temporal lobe on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging
39 weeks and 65 weeks
Change in expected increase in ventricular volume and decline in hippocampal volume as evaluated by MRI
39 weeks and 65 weeks
Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite
65 weeks
- +2 more other outcomes
Study Arms (3)
TRx0237 250 mg/day
EXPERIMENTALPlacebo
PLACEBO COMPARATORTRx0237 150 mg/day
EXPERIMENTALInterventions
Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.
Eligibility Criteria
You may qualify if:
- Diagnosis of all cause dementia and probable Alzheimer's disease
- Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score of 14-26 (inclusive)
- Age \< 90 years
- Modified Hachinski ischemic score of ≤ 4
- Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
- 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
- Has one (or more) identified adult caregiver 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 ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
- If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
- Able to comply with the study procedures
You may not qualify if:
- Significant central nervous system (CNS) disorder other than Alzheimer's disease
- Significant focal or vascular intracranial pathology seen on brain MRI scan
- Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
- Epilepsy
- Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders
- Metal implants in the head (except dental), 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 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
- Preexisting or current signs or symptoms of respiratory failure
- Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
Xenoscience, Inc/ 21st Century Neurology
Phoenix, Arizona, 85004, United States
Feldman, Robert MD
Laguna Hills, California, 92653, United States
University of Southern California
Los Angeles, California, 90033, United States
Shankle Clinic and Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Pacific Research Network
San Diego, California, 92103, United States
San Francisco Clinical Research Center
San Francisco, California, 94118, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
JEM Research
Atlantis, Florida, 33462, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
CNS Healthcare, Inc
Jacksonville, Florida, 32256, United States
Compass Research, LLC-North Clinic
Leesburg, Florida, 34748, United States
Miami Research Associates
Miami, Florida, 33143, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Alexian Brothers Neurosciences Institute
Elk Grove, Illinois, 60007, United States
ActivMed Practices & Research
Methuen, Massachusetts, 01844, United States
Olive Branch Family Medical
Olive Branch, Mississippi, 38654, United States
Memory Enhancement Centers of America, Inc
Eatontown, New Jersey, 07724, United States
CRI Worldwide
Marlton, New Jersey, 08053, United States
The Cognitive Research Center of New Jersey
Springfield, New Jersey, 07801, United States
Advanced Memory Research Institute of NJ PC
Toms River, New Jersey, 08757, United States
Neurological Associates of Albany, P. C.
Albany, New York, 12208, United States
SPRI
Brooklyn, New York, 11235, United States
Neurobehavioral Clinical Research
Canton, Ohio, 44718, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Division of Rehabilitation and Aged Care
Hornsby, New South Wales, 2077, Australia
Southern Neurology Pty Limited
Kogarah, New South Wales, 2217, Australia
Academic Department for Old Age Psychiatry, Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Discipline of Psychiatry, University of Qld
Herston, Queensland, 4006, Australia
Royal Adelaide Hospital Memory Trials Centre
Adelaide, South Australia, 5000, Australia
Memory Unit, Neurology, The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
Heidelberg West, Victoria, 3081, Australia
McCusker Alzheimer's Research Foundation Inc
Nedlands, Western Australia, 6009, Australia
Neurodegenerative Disorders Research Pty Ltd
Perth, Western Australia, 6005, Australia
UMHAT "Alexandrovska" Clinic of Neurology Diseases Department of Neurodegenerative and Immune and Infectious Diseases of Central Nervous System with Sector for Treatment of Neuroinfections
Sofia, 1431, Bulgaria
UMHAT "Alexandrovska" Clinic of Psychiatry First Department of Psychiatry
Sofia, 1431, Bulgaria
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
True North Clinical Research Kentville Inc
Kentville, Nova Scotia, B4N 4K9, Canada
Toronto Memory Program
North York, Ontario, M3B 2S7, Canada
University Hospital Centre Zagreb
Zagreb, 10000, Croatia
University Psychiatric Hospital Vrapce
Zagreb, 10090, Croatia
Neurozentrum Achim Dr. med. Andreas Mahler
Achim, 28832, Germany
Charité, University Medicine Berlin, CBF, Neurology
Berlin, 12200, Germany
Memory Clinic, ECRC
Berlin, 13125, Germany
Neurologia Ospedale Maggiore Policlinico
Milan, 20122, Italy
Istituto Neurologico Carlo Besta
Milan, 20133, Italy
IRCCS Istituto neurologico Casimiro Mondino
Pavia, 27100, Italy
Clinica Neurologica, Università di Perugia-Ospedale S. Maria della Misericordia
Perugia, 06156, Italy
Universita' Cattolica del Sacro Cuore
Roma, 00168, Italy
Azienda Ospedaliera Universitaria Sant'Andrea di Roma- Unita' di Neurologia
Roma, 00189, Italy
Dipartimento di Neuroscienze Universita' di Torino
Torino, 10126, Italy
Azienda Ospedaliera S.maria Della Misericordia
Udine, 33100, Italy
U.O. Di Neurologia Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
University Kuala Lumpur Royal College of Medicine
Ipoh, 30450, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 50603, Malaysia
Taiping Hospital
Taiping, 34000, Malaysia
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756, Poland
Pallmed sp zoo prowadząca NZOZ Dom Sue Ryder; Centrum Psychoneurologii Wieku Podeszłego
Bydgoszcz, 85-796, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, 40-123, Poland
Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
Mosina, 62-050, Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
Poznan, 61-853, Poland
Euromedis Sp. z o.o.
Szczecin, 70-111, Poland
Usługi Lekarskie Sp.c Palasik, Żabierek
Warsaw, 00-669, Poland
mMED
Warsaw, 01-697, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
County Emergency Clinical Hospital Arad, Psychiatry Department
Arad, 310022, Romania
CMDTA "Neomed"
Brasov, 500283, Romania
University Emergency Central Military Hospital "Dr.Carol Davila", Psychiatry Department
Bucharest, 010816, Romania
Psychomedical Consult
Bucharest, 024072, Romania
Clinical Municipal Hospital "Dr. Gavril Curteanu", Psychiatry Department
Oradea, 410154, Romania
Psychiatry Hospital "Dr. Gheorghe Preda", Center of Mental Health
Sibiu, 550082, Romania
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
Sibiu, 550082, Romania
Emergency Clinical County Hospital Sibiu, Neurology Department
Sibiu, 550166, Romania
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
Moscow, 109388, Russia
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
Moscow, 115522, Russia
Mental Health Research Center of the Russian Academy of Medical Sciences
Moscow, 115522, Russia
CityClinical Hospital #34, City Scientific Practical Neurological Center
Novosibirsk, 630054, Russia
City Geriatric Medical and Social Center
Saint Petersburg, 190103, Russia
Saint Nicholas Psychiatric Hospital
Saint Petersburg, 190121, Russia
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
Saint Petersburg, 192019, Russia
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
Yekaterinburg, 620030, Russia
National University Hospital (NUH)
Singapore, 119223, Singapore
National Neuroscience Institute (NNI)
Singapore, 308433, Singapore
Tan Tock Seng Hospital (TTSH)
Singapore, 308433, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Dong-A Medical Center
Busan, 602-715, South Korea
Inha University Hospital
Incheon, 400-711, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Inje University Sanggye Paik Hospital
Seoul, 139-707, South Korea
Konkuk University Medical Center
Seoul, 143-729, South Korea
Seoul National University Boramae Medical Center
Seoul, 156-707, South Korea
Hospital Universitario de Ceuta
Ceuta, 51003, Spain
Hospital Reina Sofía
Córdoba, 14011, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Viamed Montecanal
Zaragoza, 50006, Spain
Changhua Christian Hospital
Changhua, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
En Chu Kong Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
National Yang-Ming University School of Medicine
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
NHS Grampian, Department of Old Age Psychiatry Royal Cornhill Hospital
Aberdeen, AB25 2ZH, United Kingdom
RICE - The Research Institute for the Care of Older People
Bath, BA1 3NG, United Kingdom
Belfast Health and Social Care Trust (BHSCT)
Belfast, BT12 6BA, United Kingdom
The Barberry Centre
Birmingham, B15 2SG, United Kingdom
MAC Clinical Research Ltd
Blackpool, FY2 0JH, United Kingdom
MAC Clinical Research Ltd
Bradford, BD3 0DQ, United Kingdom
MAC Clinical Research Ltd
Cannock, WS11 0BN, United Kingdom
MAC Clinical Research Ltd
Leeds, LS10 1DU, United Kingdom
Re: Cognition Health Ltd.
London, W1G 9JF, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Dementia Research Centre
London, WC1N 3BG, United Kingdom
MAC Clinical Research Ltd
Manchester, M13 9NQ, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Gauthier S, Feldman HH, Schneider LS, Wilcock GK, Frisoni GB, Hardlund JH, Moebius HJ, Bentham P, Kook KA, Wischik DJ, Schelter BO, Davis CS, Staff RT, Bracoud L, Shamsi K, Storey JM, Harrington CR, Wischik CM. Efficacy and safety of tau-aggregation inhibitor therapy in patients with mild or moderate Alzheimer's disease: a randomised, controlled, double-blind, parallel-arm, phase 3 trial. Lancet. 2016 Dec 10;388(10062):2873-2884. doi: 10.1016/S0140-6736(16)31275-2. Epub 2016 Nov 16.
PMID: 27863809DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 21, 2012
Study Start
January 1, 2013
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
March 14, 2018
Record last verified: 2018-03