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Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TRx0237 150 mg/day
TRx0237 250 mg/day
Placebo
Sponsored by
TauRx Therapeutics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Alzheimer Disease, TRx0237, AD, Neurodegenerative Diseases, Dementia, Brain Diseases

Eligibility Criteria

undefined - 89 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
  • Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients

  • Treatment currently or within 3 months before Baseline with any of the following medications:

    • Tacrine
    • Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
    • Carbamazepine, primidone
    • Drugs with a warning or precaution in the labeling about methemoglobinemia at approved doses

  • Current or prior participation in a clinical trial as follows:

    • Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo)
    • A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline

Sites / Locations

  • Xenoscience, Inc/ 21st Century Neurology
  • Feldman, Robert MD
  • University of Southern California
  • Shankle Clinic and Hoag Memorial Hospital Presbyterian
  • Pacific Research Network
  • San Francisco Clinical Research Center
  • Yale University School of Medicine
  • JEM Research
  • Brain Matters Research
  • CNS Healthcare, Inc
  • Compass Research, LLC-North Clinic
  • Miami Research Associates
  • Compass Research, LLC
  • iResearch Atlanta
  • Alexian Brothers Neurosciences Institute
  • ActivMed Practices & Research
  • Olive Branch Family Medical
  • Memory Enhancement Centers of America, Inc
  • CRI Worldwide
  • The Cognitive Research Center of New Jersey
  • Advanced Memory Research Institute of NJ PC
  • Neurological Associates of Albany, P. C.
  • SPRI
  • Neurobehavioral Clinical Research
  • The Clinical Trial Center, LLC
  • FutureSearch Trials of Neurology
  • Division of Rehabilitation and Aged Care
  • Southern Neurology Pty Limited
  • Academic Department for Old Age Psychiatry, Prince of Wales Hospital
  • Discipline of Psychiatry, University of Qld
  • Royal Adelaide Hospital Memory Trials Centre
  • Memory Unit, Neurology, The Queen Elizabeth Hospital
  • Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
  • McCusker Alzheimer's Research Foundation Inc
  • Neurodegenerative Disorders Research Pty Ltd
  • UMHAT "Alexandrovska" Clinic of Neurology Diseases Department of Neurodegenerative and Immune and Infectious Diseases of Central Nervous System with Sector for Treatment of Neuroinfections
  • UMHAT "Alexandrovska" Clinic of Psychiatry First Department of Psychiatry
  • Okanagan Clinical Trials
  • True North Clinical Research Kentville Inc
  • Toronto Memory Program
  • University Hospital Centre Zagreb
  • University Psychiatric Hospital Vrapce
  • Neurozentrum Achim Dr. med. Andreas Mahler
  • Charité, University Medicine Berlin, CBF, Neurology
  • Memory Clinic, ECRC
  • Neurologia Ospedale Maggiore Policlinico
  • Istituto Neurologico Carlo Besta
  • IRCCS Istituto neurologico Casimiro Mondino
  • Clinica Neurologica, Università di Perugia-Ospedale S. Maria della Misericordia
  • Universita' Cattolica del Sacro Cuore
  • Azienda Ospedaliera Universitaria Sant'Andrea di Roma- Unita' di Neurologia
  • Dipartimento di Neuroscienze Universita' di Torino
  • Azienda Ospedaliera S.maria Della Misericordia
  • U.O. Di Neurologia Ospedale di Circolo e Fondazione Macchi
  • Dong-A Medical Center
  • Inha University Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Inje University Sanggye Paik Hospital
  • Konkuk University Medical Center
  • Seoul National University Boramae Medical Center
  • University Kuala Lumpur Royal College of Medicine
  • Hospital Sultan Ismail
  • University Malaya Medical Centre
  • Taiping Hospital
  • Podlaskie Centrum Psychogeriatrii
  • Pallmed sp zoo prowadząca NZOZ Dom Sue Ryder; Centrum Psychoneurologii Wieku Podeszłego
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
  • Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
  • Euromedis Sp. z o.o.
  • Usługi Lekarskie Sp.c Palasik, Żabierek
  • mMED
  • MTZ Clinical Research Sp. z o.o.
  • County Emergency Clinical Hospital Arad, Psychiatry Department
  • CMDTA "Neomed"
  • University Emergency Central Military Hospital "Dr.Carol Davila", Psychiatry Department
  • Psychomedical Consult
  • Clinical Municipal Hospital "Dr. Gavril Curteanu", Psychiatry Department
  • Psychiatry Hospital "Dr. Gheorghe Preda", Center of Mental Health
  • Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
  • Emergency Clinical County Hospital Sibiu, Neurology Department
  • State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
  • Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
  • Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
  • Mental Health Research Center of the Russian Academy of Medical Sciences
  • CityClinical Hospital #34, City Scientific Practical Neurological Center
  • City Geriatric Medical and Social Center
  • Saint Nicholas Psychiatric Hospital
  • Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
  • National University Hospital (NUH)
  • National Neuroscience Institute (NNI)
  • Tan Tock Seng Hospital (TTSH)
  • Changi General Hospital
  • Hospital Universitario de Ceuta
  • Hospital Reina Sofía
  • Hospital Clinico San Carlos
  • Hospital Viamed Montecanal
  • Changhua Christian Hospital
  • Chang Gung Memorial Hospital, Kaohsiung
  • China Medical University Hospital
  • En Chu Kong Hospital
  • National Taiwan University Hospital
  • National Yang-Ming University School of Medicine
  • Chang Gung Memorial Hospital, Linkou
  • NHS Grampian, Department of Old Age Psychiatry Royal Cornhill Hospital
  • RICE - The Research Institute for the Care of Older People
  • Belfast Health and Social Care Trust (BHSCT)
  • The Barberry Centre
  • MAC Clinical Research Ltd
  • MAC Clinical Research Ltd
  • MAC Clinical Research Ltd
  • MAC Clinical Research Ltd
  • Re: Cognition Health Ltd.
  • Charing Cross Hospital
  • Dementia Research Centre
  • MAC Clinical Research Ltd
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

TRx0237 250 mg/day

Placebo

TRx0237 150 mg/day

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
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

Secondary Outcome Measures

Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Change from Baseline on Mini-Mental Status Examination (MMSE)
Change in expected decline of whole brain volume as measured by brain MRI

Full Information

First Posted
September 14, 2012
Last Updated
March 12, 2018
Sponsor
TauRx Therapeutics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01689246
Brief Title
Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Official Title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TauRx Therapeutics Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, Alzheimer Disease, TRx0237, AD, Neurodegenerative Diseases, Dementia, Brain Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
891 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRx0237 250 mg/day
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
TRx0237 150 mg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TRx0237 150 mg/day
Intervention Description
TRx0237 75 mg tablets will be administered twice daily.
Intervention Type
Drug
Intervention Name(s)
TRx0237 250 mg/day
Intervention Description
TRx0237 125 mg tablets will be administered twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
Time Frame
65 weeks
Title
Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
Time Frame
65 weeks
Title
Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
Description
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
Time Frame
65 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Time Frame
65 weeks
Title
Change from Baseline on Mini-Mental Status Examination (MMSE)
Time Frame
65 weeks
Title
Change in expected decline of whole brain volume as measured by brain MRI
Time Frame
39 weeks and 65 weeks
Other Pre-specified Outcome Measures:
Title
Reduction in glucose uptake decline in the temporal lobe on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging
Time Frame
39 weeks and 65 weeks
Title
Change in expected increase in ventricular volume and decline in hippocampal volume as evaluated by MRI
Time Frame
39 weeks and 65 weeks
Title
Change in resource utilization using the Resource Utilization in Dementia (RUD) Lite
Time Frame
65 weeks
Title
Change from Baseline on cerebrospinal fluid biomarkers of Alzheimer's Disease in subjects who separately consent to lumbar puncture
Time Frame
65 weeks
Title
Compare the influence of Apolipoprotein E genotype on the primary and selected secondary outcomes in subjects by or for whom legally acceptable consent is separately provided
Time Frame
65 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients Treatment currently or within 3 months before Baseline with any of the following medications: Tacrine Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study) Carbamazepine, primidone Drugs with a warning or precaution in the labeling about methemoglobinemia at approved doses Current or prior participation in a clinical trial as follows: Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo) A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline
Facility Information:
Facility Name
Xenoscience, Inc/ 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Feldman, Robert MD
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Shankle Clinic and Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
JEM Research
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
CNS Healthcare, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Compass Research, LLC-North Clinic
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Alexian Brothers Neurosciences Institute
City
Elk Grove
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
ActivMed Practices & Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Olive Branch Family Medical
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Memory Enhancement Centers of America, Inc
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
CRI Worldwide
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
The Cognitive Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07801
Country
United States
Facility Name
Advanced Memory Research Institute of NJ PC
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08757
Country
United States
Facility Name
Neurological Associates of Albany, P. C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
SPRI
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Neurobehavioral Clinical Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Division of Rehabilitation and Aged Care
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Southern Neurology Pty Limited
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Academic Department for Old Age Psychiatry, Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Discipline of Psychiatry, University of Qld
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Royal Adelaide Hospital Memory Trials Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Memory Unit, Neurology, The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
McCusker Alzheimer's Research Foundation Inc
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Neurodegenerative Disorders Research Pty Ltd
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
UMHAT "Alexandrovska" Clinic of Neurology Diseases Department of Neurodegenerative and Immune and Infectious Diseases of Central Nervous System with Sector for Treatment of Neuroinfections
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Alexandrovska" Clinic of Psychiatry First Department of Psychiatry
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
True North Clinical Research Kentville Inc
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
Toronto Memory Program
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Psychiatric Hospital Vrapce
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
Neurozentrum Achim Dr. med. Andreas Mahler
City
Achim
ZIP/Postal Code
28832
Country
Germany
Facility Name
Charité, University Medicine Berlin, CBF, Neurology
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Memory Clinic, ECRC
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Neurologia Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS Istituto neurologico Casimiro Mondino
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Clinica Neurologica, Università di Perugia-Ospedale S. Maria della Misericordia
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Universita' Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Sant'Andrea di Roma- Unita' di Neurologia
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Dipartimento di Neuroscienze Universita' di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera S.maria Della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
U.O. Di Neurologia Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Dong-A Medical Center
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
University Kuala Lumpur Royal College of Medicine
City
Ipoh
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
ZIP/Postal Code
81100
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Taiping Hospital
City
Taiping
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Podlaskie Centrum Psychogeriatrii
City
Białystok
ZIP/Postal Code
15-756
Country
Poland
Facility Name
Pallmed sp zoo prowadząca NZOZ Dom Sue Ryder; Centrum Psychoneurologii Wieku Podeszłego
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
City
Mosina
ZIP/Postal Code
62-050
Country
Poland
Facility Name
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
City
Poznań
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Euromedis Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Usługi Lekarskie Sp.c Palasik, Żabierek
City
Warszawa
ZIP/Postal Code
00-669
Country
Poland
Facility Name
mMED
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
County Emergency Clinical Hospital Arad, Psychiatry Department
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
CMDTA "Neomed"
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
University Emergency Central Military Hospital "Dr.Carol Davila", Psychiatry Department
City
Bucharest
ZIP/Postal Code
010816
Country
Romania
Facility Name
Psychomedical Consult
City
Bucharest
ZIP/Postal Code
024072
Country
Romania
Facility Name
Clinical Municipal Hospital "Dr. Gavril Curteanu", Psychiatry Department
City
Oradea
ZIP/Postal Code
410154
Country
Romania
Facility Name
Psychiatry Hospital "Dr. Gheorghe Preda", Center of Mental Health
City
Sibiu
ZIP/Postal Code
550082
Country
Romania
Facility Name
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
City
Sibiu
ZIP/Postal Code
550082
Country
Romania
Facility Name
Emergency Clinical County Hospital Sibiu, Neurology Department
City
Sibiu
ZIP/Postal Code
550166
Country
Romania
Facility Name
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
City
Moscow
ZIP/Postal Code
109388
Country
Russian Federation
Facility Name
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Mental Health Research Center of the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
CityClinical Hospital #34, City Scientific Practical Neurological Center
City
Novosibirsk
ZIP/Postal Code
630054
Country
Russian Federation
Facility Name
City Geriatric Medical and Social Center
City
Saint Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Saint Nicholas Psychiatric Hospital
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
National University Hospital (NUH)
City
Singapore
ZIP/Postal Code
119223
Country
Singapore
Facility Name
National Neuroscience Institute (NNI)
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Tan Tock Seng Hospital (TTSH)
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Hospital Universitario de Ceuta
City
Ceuta
ZIP/Postal Code
51003
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14011
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
ZIP/Postal Code
50006
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Kaohsiung
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
En Chu Kong Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
National Yang-Ming University School of Medicine
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
Country
Taiwan
Facility Name
NHS Grampian, Department of Old Age Psychiatry Royal Cornhill Hospital
City
Aberdeen
ZIP/Postal Code
AB25 2ZH
Country
United Kingdom
Facility Name
RICE - The Research Institute for the Care of Older People
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust (BHSCT)
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
The Barberry Centre
City
Birmingham
ZIP/Postal Code
B15 2SG
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Bradford
ZIP/Postal Code
BD3 0DQ
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Cannock
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Leeds
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Facility Name
Re: Cognition Health Ltd.
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Dementia Research Centre
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
MAC Clinical Research Ltd
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27863809
Citation
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.
Results Reference
derived
Links:
URL
http://www.AlzheimersStudies.com
Description
Alzheimer's Survey

Learn more about this trial

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

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