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RO4602522 in Patients with Moderate Alzheimer Disease on Donepezil or Rivastigmine Therapy

  • Completed

The purpose of this Phase II study is to evaluate the efficacy and safety of RO4602522 in people with moderate-stage Alzheimer disease who have been taking donepezil or rivastigmine for at least 6 months.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years Both No
November 2012
June 2015
420

++Probable Alzheimer's disease ++Mini Mental State Examination score of 14-20 inclusive; Modified Hachinski Ischemia Score of 4 or less; Cornell Scale for Depression in Dementia (CSDD) score of 13 or less ++Body mass index (BMI) between 18 and 36 kg/m2 inclusive ++Taking donepezil (5 to 10 mg daily) or rivastigmine (4.6 mg daily or 9.5 mg daily patch) for at least 6 months; dose and formulation stable for at least 3 months; participants taking rivastigmine tablets are eligible but must switch to patch during the study ++Females of childbearing potential must have negative pregnancy test and agree to use effective contraception ++Generally healthy and ambulatory or ambulatory-aided (walker or cane acceptable) ++Reliable caregiver or other person who has frequent contact with the participant

++Any neurological or psychiatric condition not specified in protocol exceptions ++Mental retardation ++Uncontrolled behavioral symptoms incompatible with compliance or evaluability ++Alcohol and/or substance abuse or dependence in the past 2 years, except nicotine use, which is allowed. (Smokers treated with nicotine replacement therapy or bupropion are excluded.) ++Unstable or poorly controlled hypertension ++Unstable or clinically significant cardiovascular disease that could progress, recur, or change significantly during study period ++Inadequate hepatic, renal or thyroid function ++Positive for hepatitis B, hepatitis C, or HIV infection ++Poorly controlled diabetes ++Requires nursing home care ++Participation at any time in an active Alzheimer's disease vaccine study; participation in a passive Alzheimer's immunization study less than 1 year before screening ++Prohibited medications: Alzheimer's disease treatment other than donepezil or rivastigmine; psychotropic medication

This Phase II study will evaluate the efficacy and safety of RO4602522 in people with moderate-stage Alzheimer's disease . Participants who are taking donepezil or rivastigmine for at least 6 months before the study begins will be randomized to receive either one of two doses of RO4602522 or a placebo for 12 months.

For more information about this clinical trial or study sites, please call 1-888-662-6728 (U.S. only) or email  genentechclinicaltrials@druginfo.com. Reference Study ID number BP28248.

Name City State Zip Status Primary Contact
Advanced Research Center, Inc.;In-Patient Unit Anaheim California 92801

Neurology Center of North Orange County Fullerton California 92835

Torrance Clinical Research Lomita California 90717

Artemis Institute for Clinical Research, LLC San Diego California 92103

Sharp Mesa Vista Hospital San Diego California 92123

San Francisco Clinical Research Center San Francisco California 94109

Neurological Research Inst Santa Monica California 90025

Yale University School Of Medicine New Haven Connecticut 06510

Research Center for Clinical Studies, Inc. Norwalk Connecticut 06851

Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida 33486

Meridien Research Brooksville Florida 34601

Brain Matters Research, Inc. Delray Beach Florida 33445

Neurologic Consultants, P.A. Fort Lauderdale Florida 33308

Galiz Research, LLC Hialeah Florida 33016

Miami Jewish Health Systems Miami Florida 33137

Medical Research Group of Central Florida Orange City Florida 3273

Compass Research East, LLC Orlando Florida 32806

Comprehensive Clinical Development, Inc.- St. Petersburg, FL Saint Petersburg Florida 33716

Axiom Clinical Research of Florida Tampa Florida 33609

Premiere Research Institute West Palm Beach Florida 33407

iResearch Atlanta Decatur Georgia 30030

NeuroStudies.net, LLC Decatur Georgia 30033

Alexian Brothers Neurosci Inst Elk Grove Village Illinois 60007

Louisiana Research Associates New Orleans Louisiana 70114

Booker, J. Gary, MD, APMC Shreveport Louisiana 71104-2136

Northern Michigan Neurology Traverse City Michigan 49684

Hattiesburg Clinic Hattiesburg Mississippi 39401

Millennium Psychiatric Associates, LLC Creve Coeur Missouri 63141

Memory Enhancement Center of America, Inc. Eatontown New Jersey 07724

Albuquerque Neuroscience Inc. Albuquerque New Mexico 87109

New York University Medical Center;Child Study Center New York New York 10016

Richmond Behavioral Associates Staten Island New York 10312

Raleigh Neurology Associates Raleigh North Carolina 27607-6520

PMG Research of Winston-Salem, LLC Winston-Salem North Carolina 27103

Lynn Health Science Institute Oklahoma City Oklahoma 73112

Cutting Edge Research Group Oklahoma City Oklahoma 73116

The Clinical Trial Center, LLC Jenkintown Pennsylvania 19046

Radiant Research, Inc. Wyomissing Pennsylvania 19610

Rhode Island Mood & Memory Research Institute East Providence Rhode Island 02914

Rhode Island Hospital Providence Rhode Island 02903

Alzheimer's Research & Clinical Programs Charleston South Carolina 29425

University of North Texas Health Science Center Fort Worth Texas 76107

St Vincent's Hospital Sydney Darlinghurst New South Wales 2010

Central Coast Neurosciences Research Erina New South Wales 2250

Southern Neurology Kogarah New South Wales 2217

Queen Elizabeth Hospital Woodville South Australia 5011

Box Hill Hospital; Eastern Clinical Research Unit Box Hill Victoria 3128

A.G.Mander Pty Ltd Geelong Victoria 3220

Heidelberg Repatriation Hospital Heidelberg Victoria 3084

Hollywood Specialist Centre Nedlands Western Australia 6009

Neurodegenerative Disorders Research Subiaco Western Australia 6008

The Medical Arts Health Research Group Powell River British Columbia V8A 3B6

Vancouver Hospital - UBC Hospital Site Vancouver British Columbia V6T 2B5

Vancouver Island Health Authority Victoria British Columbia V8R 1J8

Capitol District Health Authority Halilfax Nova Scotia B3H 2E1

True North Clinical Research Kentville Kentville Nova Scotia B4N 4K9

Jbn Medical Diagnostic Services Inc. Burlington Ontario L7M 4Y1

Bruyere Continuing Care Ottawa Ontario K1N 5C8

Ingram, Jennifer MD Peterborough Ontario K9H 3S1

Toronto Memory Program (Neurology Research Inc.) Toronto Ontario M3B 2S7

The Centre for Memory and Aging Toronto Ontario M4G 3E8

Toronto Sunnybrook Hospital Toronto Ontario M4N 3M5

Recherches Neuro-Hippocame Gatineau Quebec J8T 8J1

Clinique Neuro Rive-Sud Greenfield Park Quebec J4V 2J2

Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll Sherbrooke Quebec J1J 3H5

McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric Verdun Quebec H4H 1R3

CHU de Quebec - Hôpital de l' Enfant Jésus Quebec G1J 1Z4

NEUROHK s.r.o. Chocen 565 01

P-P Klinika Kladno 272 80

Supervize s.r.o. Kutna Hora - Vnitrni Mesto 284 01

Nemocnice Na Bulovce Prague 180 01

Clintrial,s.r.o. Praha 10 100 00

AD71 s.r.o. Praha 10 102 00

Thomayerova nemocnice Praha 4 - Krc 140 59

Psychiatry Trial s.r.o. Praha 5 158 00

Neurologicka ambulance Praha 6 16000

FORBELI s.r.o. Praha 6 165 00

Centre Hospitalier de la côte Basque Bayonne 64109

Hopital Neurologique Pierre Wertheimer Bron 69500

Hopital Nord Laënnec - CHU Nantes Nantes 44093

Hopital Cimiez; CMRR Nice 06003

Hôpital Lariboisière Paris 75475

Groupe Hospitalier Sud - Hôpital Xavier Arnozan Pessac 33604

Hôpital Maison Blanche Reims 51092

CHU Rennes - Hopital Hôtel Dieu Rennes 35064

CHU Toulouse - La Grave Toulouse 31059

CHU Tours - Hôpital Bretonneau Tours 37044

Hôpital de Brabois Adultes Vandoeuvre-les-nancy 54511

Hopital des Charpennes Villeurbanne 69100

Gemeinschaftspraxis Ellwangen 73479

Henriettenstiftung Hannover Hannover 30559

ISPG - Institut fuer Studien zur Psychischen Gesundheit Mannheim 68165

Klinikum rechts der Isar der Technischen Universität München Munchen 81675

Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung Siegen 57072

Nuovo Ospedale Civile S.Agostino - Estense Modena Emilia-Romagna 41126

Policlinico Universitario Agostino Gemelli; Farmacia Roma Lazio 00168

Fondazione Santa Lucia IRCCS Roma Lazio 00179

Umberto I Policlinico di Roma-Università di Roma La Sapienza Roma Lazio 00185

Ente Ospedaliero Ospedali Galliera Genova Liguria 16128

Università degli Studi di Genova Genova Liguria 16132

Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica Pisa Toscana 56126

Università degli studi di Perugia Perugia Umbria 06126

Dong-A University Hospital Busan 49201

Seoul National University Bundang Hospital Gyeonggi-do 13620

Ajou University Hospital Gyeonggi-do 443-380

Inha University Hospital; Pulmonary Medicine Incheon 400-711

Kyung Hee University Hospital Seoul 02447

Korea University Anam Hospital Seoul 02841

Severance Hospital, Yonsei University Health System Seoul 03722

Konkuk University Medical Center Seoul 05030

Samsung Medical Center Seoul 06351

Podlaskie Centrum Psychogeriatrii Bialystok 15-732

Uniwersyteckie Centrum Kliniczne Gdansk 80-214

Specjal. Praktyka Lekarska; Prof. Grzegorz Opala Katowice 40-588

Centrum Medyczne Dendryt Katowice 40-684

NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek Poznan 61-289

NZOZ Syntonia Pruszcz Gdanski 83-000

NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog Sopot 81-717

mMED Maciej Czarnecki Warszawa 01-697

Instytut Psychiatrii i Neurologii Warszawa 02-957

Hospital General Universitario de Elche; Servicio de Farmacia Elche Alicante 03203

Fundació ACE BArcelon Barcelona 08034

Hospital General De Catalunya; Servicio de Neurologia Sant Cugat del Valles Barcelona 8195

Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid 28222

Hospital Virgen del Puerto Plasencia Palencia 10600

Hospital Universitario Virgen Macarena Seville Sevilla 41071

CAE Oroitu BaraKaldo Vizcaya 48903

Hospital Perpetuo Socorro, Servicio de Geriatria Albacete 2006

Hospital de la Santa Creu i Sant Pau Barcelona 08041

Hospital Universitario Ramón y Cajal Madrid 28034

Hospital Universitario Clínico San Carlos Madrid 28040

Hospital Universitari i Politecnic La Fe Valencia 46026

Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo Malmö 205 02

Karolinska Universitetssjukhuset Huddinge Stockholm 171 64

Cognitive Treatment & Research Unit Crowborough TN6 1HB

Ninewells Hospital Dundee DD12 9SY

Glasgow Memory Clinic Glasgow G20 0XA

West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit Isleworth TW7 6FY

Institute of Psychiatry London SE5 8AF

Norwich Medical School Norwich NR4 7UY

Derriford Hospital Plymouth PL6 8DH

Memory Service North Sheffield S35 8QS

Hoffmann-La Roche

Name Role Affiliation
Study Director Hoffmann-La Roche

Name Phone Extension Email
Genentech 888-662-6728 (U.S. only) genentechclinicaltrials@druginfo.com