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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

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

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

Hoffmann-La Roche

Name Role Affiliation
Study Director Hoffmann-La Roche

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

NCT01677754