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

PHASE3CompletedINTERVENTIONAL
Enrollment

891

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Alzheimer's Disease
Interventions
DRUG

TRx0237 150 mg/day

TRx0237 75 mg tablets will be administered twice daily.

DRUG

TRx0237 250 mg/day

TRx0237 125 mg tablets will be administered twice daily.

DRUG

Placebo

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.

Trial Locations (121)

1431

"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

"UMHAT Alexandrovska Clinic of Psychiatry First Department of Psychiatry", Sofia

2031

Academic Department for Old Age Psychiatry, Prince of Wales Hospital, Randwick

2077

Division of Rehabilitation and Aged Care, Hornsby

2217

Southern Neurology Pty Limited, Kogarah

3081

Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital, Heidelberg West

4006

Discipline of Psychiatry, University of Qld, Herston

5000

Royal Adelaide Hospital Memory Trials Centre, Adelaide

5011

Memory Unit, Neurology, The Queen Elizabeth Hospital, Woodville South

6005

Neurodegenerative Disorders Research Pty Ltd, Perth

6009

McCusker Alzheimer's Research Foundation Inc, Nedlands

10000

University Hospital Centre Zagreb, Zagreb

10090

University Psychiatric Hospital Vrapce, Zagreb

10126

Dipartimento di Neuroscienze Universita' di Torino, Torino

11235

SPRI, Brooklyn

12200

Charité, University Medicine Berlin, CBF, Neurology, Berlin

12208

Neurological Associates of Albany, P. C., Albany

13125

Memory Clinic, ECRC, Berlin

14011

Hospital Reina Sofía, Córdoba

19046

The Clinical Trial Center, LLC, Jenkintown

20122

Neurologia Ospedale Maggiore Policlinico, Milan

20133

Istituto Neurologico Carlo Besta, Milan

21100

U.O. Di Neurologia Ospedale di Circolo e Fondazione Macchi, Varese

27100

IRCCS Istituto neurologico Casimiro Mondino, Pavia

28040

Hospital Clinico San Carlos, Madrid

28832

Neurozentrum Achim Dr. med. Andreas Mahler, Achim

30030

iResearch Atlanta, Decatur

30450

University Kuala Lumpur Royal College of Medicine, Ipoh

32256

CNS Healthcare, Inc, Jacksonville

32806

Compass Research, LLC, Orlando

33100

Azienda Ospedaliera S.maria Della Misericordia, Udine

33143

Miami Research Associates, Miami

33445

Brain Matters Research, Delray Beach

33462

JEM Research, Atlantis

34000

Taiping Hospital, Taiping

34748

Compass Research, LLC-North Clinic, Leesburg

38654

Olive Branch Family Medical, Olive Branch

44718

Neurobehavioral Clinical Research, Canton

50006

Hospital Viamed Montecanal, Zaragoza

50603

University Malaya Medical Centre, Kuala Lumpur

51003

Hospital Universitario de Ceuta, Ceuta

60007

Alexian Brothers Neurosciences Institute, Elk Grove

78731

FutureSearch Trials of Neurology, Austin

81100

Hospital Sultan Ismail, Johor Bahru

85004

Xenoscience, Inc/ 21st Century Neurology, Phoenix

90033

University of Southern California, Los Angeles

92103

Pacific Research Network, San Diego

92653

Feldman, Robert MD, Laguna Hills

92658

Shankle Clinic and Hoag Memorial Hospital Presbyterian, Newport Beach

94118

San Francisco Clinical Research Center, San Francisco

109388

"Non-governmental Healthcare Institution Central Clinical Hospital #6 of the JSC Russian Railways", Moscow

115522

Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department, Moscow

Mental Health Research Center of the Russian Academy of Medical Sciences, Moscow

119223

National University Hospital (NUH), Singapore

190103

City Geriatric Medical and Social Center, Saint Petersburg

190121

Saint Nicholas Psychiatric Hospital, Saint Petersburg

192019

Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev, Saint Petersburg

308433

National Neuroscience Institute (NNI), Singapore

Tan Tock Seng Hospital (TTSH), Singapore

310022

County Emergency Clinical Hospital Arad, Psychiatry Department, Arad

410154

"Clinical Municipal Hospital Dr. Gavril Curteanu, Psychiatry Department", Oradea

500283

"CMDTA Neomed", Brasov

529889

Changi General Hospital, Singapore

550082

"Psychiatry Hospital Dr. Gheorghe Preda, Center of Mental Health", Sibiu

"Psychiatry Hospital Dr. Gheorghe Preda, Department of Psychiatry III", Sibiu

550166

Emergency Clinical County Hospital Sibiu, Neurology Department, Sibiu

620030

"State Budgetary Healthcare Institution of Sverdlovsk region Sverdlovsk Regional Clinical Psychiatric Hospital", Yekaterinburg

630054

CityClinical Hospital #34, City Scientific Practical Neurological Center, Novosibirsk

06510

Yale University School of Medicine, New Haven

01844

ActivMed Practices & Research, Methuen

07724

Memory Enhancement Centers of America, Inc, Eatontown

08053

CRI Worldwide, Marlton

07801

The Cognitive Research Center of New Jersey, Springfield

08757

Advanced Memory Research Institute of NJ PC, Toms River

V1Y 1Z9

Okanagan Clinical Trials, Kelowna

B4N 4K9

True North Clinical Research Kentville Inc, Kentville

M3B 2S7

Toronto Memory Program, North York

06156

Clinica Neurologica, Università di Perugia-Ospedale S. Maria della Misericordia, Perugia

00168

Universita' Cattolica del Sacro Cuore, Roma

00189

Azienda Ospedaliera Universitaria Sant'Andrea di Roma- Unita' di Neurologia, Roma

15-756

Podlaskie Centrum Psychogeriatrii, Bialystok

85-796

Pallmed sp zoo prowadząca NZOZ Dom Sue Ryder; Centrum Psychoneurologii Wieku Podeszłego, Bydgoszcz

40-123

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Katowice

62-050

Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska, Mosina

61-853

NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy, Poznan

70-111

Euromedis Sp. z o.o., Szczecin

00-669

Usługi Lekarskie Sp.c Palasik, Żabierek, Warsaw

01-697

mMED, Warsaw

02-106

MTZ Clinical Research Sp. z o.o., Warsaw

010816

"University Emergency Central Military Hospital Dr.Carol Davila, Psychiatry Department", Bucharest

024072

Psychomedical Consult, Bucharest

602-715

Dong-A Medical Center, Busan

400-711

Inha University Hospital, Incheon

405-760

Gachon University Gil Medical Center, Incheon

463-707

Seoul National University Bundang Hospital, Seongnam-si

110-744

Seoul National University Hospital, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

139-707

Inje University Sanggye Paik Hospital, Seoul

143-729

Konkuk University Medical Center, Seoul

156-707

Seoul National University Boramae Medical Center, Seoul

Unknown

Changhua Christian Hospital, Changhua

Chang Gung Memorial Hospital, Kaohsiung, Kaohsiung City

China Medical University Hospital, Taichung

En Chu Kong Hospital, Taipei

National Taiwan University Hospital, Taipei

National Yang-Ming University School of Medicine, Taipei

Chang Gung Memorial Hospital, Linkou, Taoyuan District

AB25 2ZH

NHS Grampian, Department of Old Age Psychiatry Royal Cornhill Hospital, Aberdeen

BA1 3NG

RICE - The Research Institute for the Care of Older People, Bath

BT12 6BA

Belfast Health and Social Care Trust (BHSCT), Belfast

B15 2SG

The Barberry Centre, Birmingham

FY2 0JH

MAC Clinical Research Ltd, Blackpool

BD3 0DQ

MAC Clinical Research Ltd, Bradford

WS11 0BN

MAC Clinical Research Ltd, Cannock

LS10 1DU

MAC Clinical Research Ltd, Leeds

W1G 9JF

Re: Cognition Health Ltd., London

W6 8RF

Charing Cross Hospital, London

WC1N 3BG

Dementia Research Centre, London

M13 9NQ

MAC Clinical Research Ltd, Manchester

SO16 6YD

Southampton General Hospital, Southampton

All Listed Sponsors
lead

TauRx Therapeutics Ltd

INDUSTRY

NCT01689246 - Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease | Biotech Hunter | Biotech Hunter