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Gantenerumab for Early Alzheimer's Disease

Recruiting

This Phase III clinical trial will evaluate the efficacy and safety of gantenerumab in people with early-stage Alzheimer's disease. Gantenerumab is an experimental medication that is being investigated for its ability to reduce beta-amyloid plaques in the brain that are associated with Alzheimer's disease. This trial is similar to Safety and Efficacy of Gantenerumab for Early Alzheimer's, but recruiting in different locations.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years All No
June 6, 2018
November 2, 2023
760

  • Probable early Alzheimer's disease (using National Institute on Aging/Alzheimer's Association core clinical criteria and guidelines for mild cognitive impairment)
  • Evidence of the Alzheimer's pathological process, as confirmed by samples of cerebral spinal fluid or positron emission tomography scan
  • Demonstrated abnormal memory function
  • Mini-Mental State Examination score of 22 or greater
  • Clinical Dementia Rating-global score of 0.5 or 1.0
  • Reliable study partner who agrees to participate in study procedures 
  • If taking any medication for symptoms of Alzheimer's disease, on a stable dose for 3 months prior to the study

  • Any evidence of a condition other than Alzheimer's disease that may affect cognition
  • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
  • History or presence of systemic vascular disease that has the potential to affect cognitive function
  • History or presence of cerebrovascular disease
  • At risk for suicide in the opinion of the investigator
  • Evidence of folic acid deficiency
  • Alcohol and/or substance abuse or dependence in the past 2 years
  • Brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities
  • Contraindications to brain magnetic resonance imaging (MRI)
  • Unstable or clinically significant cardiovascular, kidney, or liver disease
  • Uncontrolled hypertension

Participants will receive subcutaneous injections of either gantenerumab or a placebo on a schedule lasting 2 years. Participants may then choose to enter into an open-label extension, which means they will know which treatment is being administered. Followup will continue for individuals not participating in the extension for up to 50 weeks after their last dose. Participants will undergo MRI.

For more information about this study, call 888-662-6728 (toll-free; U.S. and Canada) or email global-roche-genentech-trials@gene.com.

Name City State Zip Status Primary Contact
Center for Neurosciences
Tucson Arizona 85718 Active, not recruiting

CITrials, Inc.
Bellflower California 90706 Withdrawn

Global Clinical Trials; Irvine, CA
Irvine California 92614 Completed

Excell Research
Oceanside California 92056 Withdrawn

ASCLEPES Research Centers
Panorama City California 91402 Withdrawn

CITrials, Inc.
Riverside California 92506 Withdrawn

Sutter Medical Group, Neurology
Sacramento California 95816 Active, not recruiting

University of California, Davis; Alzheimers Disease Center, Department of Neurology
Sacramento California 95817 Withdrawn

Syrentis Clinical Research
Santa Ana California 92705 Active, not recruiting

North Bay Neuro Science Institute
Sebastopol California 95472 Withdrawn

California Neuroscience Research Medical Group, Inc
Sherman Oaks California 91403 Active, not recruiting

Upland Clinical Research
Upland California 91789 Withdrawn

Coastal Connecticut Research, Llc
New London Connecticut 06320 Withdrawn

Research Center for Clinical Studies, Inc.
Norwalk Connecticut 06851 Active, not recruiting

Comprehensive Psychiatric Care
Norwich Connecticut 06360 Withdrawn

JEM Research LLC
Atlantis Florida 33462 Active, not recruiting

Bradenton Research Center
Bradenton Florida 34205 Active, not recruiting

Clinical Research of South Florida
Coral Gables Florida 33134 Withdrawn

Brain Matters Research, Inc.
Delray Beach Florida 33445 Active, not recruiting

SIH Research
Kissimmee Florida 34759 Withdrawn

Combined Research Orlando Phase I-IV
Orlando Florida 32807 Withdrawn

Global Medical Institues, LLC; Central Miami Medical Institute
South Miami Florida 33143 Withdrawn

Alzheimer's Research and Treatment Center
Wellington Florida 33414 Active, not recruiting

Atlanta Center For Medical Research
Atlanta Georgia 30331 Withdrawn

Columbus Memory Center
Columbus Georgia 31909 Active, not recruiting

Center for Advanced Research & Education
Gainesville Georgia 30501 Active, not recruiting

University of Chicago; Neurology
Chicago Illinois 60637 Withdrawn

Southern Illinois University, School of Medicine
Springfield Illinois 62702 Active, not recruiting

Neuropsychiatric Research
Winfield Illinois 60190 Withdrawn

Fort Wayne Neurological Center
Fort Wayne Indiana 46805 Active, not recruiting

Josephson Wallack Munshower Neurology PC
Indianapolis Indiana 46256 Withdrawn

Via Christi Research
Wichita Kansas 67214 Active, not recruiting

Precise Research Centers
Flowood Mississippi 39232 Active, not recruiting

University of Mississippi Medical Center
Jackson Mississippi 39216 Active, not recruiting

Galen Clinical Research
Chesterfield Missouri 63005 Withdrawn

NeuroCognitive Institute
Mount Arlington New Jersey 07856 Withdrawn

Advanced Memory Research Institute of NJ
Toms River New Jersey 08755 Active, not recruiting

Neurology Specialists of Monmouth County, PA
West Long Branch New Jersey 07764 Withdrawn

Neurological Associates of Long Island, PC
Lake Success New York 11042 Active, not recruiting

Weill Cornell Memory Disorders
New York New York 10021 Withdrawn

Columbia University Medical Center
New York New York 10027 Active, not recruiting

Richard H Weisler, MD
Raleigh North Carolina 27609 Withdrawn

Ohio State University; College of Medicine
Columbus Ohio 43210 Active, not recruiting

UC Health Neurology
Dayton Ohio 45417 Withdrawn

Oregon Center for Clinical Investigations, Inc
Portland Oregon 97210 Withdrawn

Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center
Portland Oregon 97239 Withdrawn

Abington Neurological Associates
Abington Pennsylvania 19001 Active, not recruiting

The Clinical Trial Center, LLC
Jenkintown Pennsylvania 19046 Active, not recruiting

Drexel University; College of Medicine
Philadelphia Pennsylvania 19102 Completed

Medical University of South Carolina
Charleston South Carolina 29425 Withdrawn

Coastal Neurology
Port Royal South Carolina 29935 Active, not recruiting

University of Tennessee Medical Center
Knoxville Tennessee 37920 Withdrawn

Clinical Research Associates
Nashville Tennessee 37203 Withdrawn

FutureSearch Trials, LP
Austin Texas 78731 Withdrawn

Senior Adults Specialty Research
Austin Texas 78757 Active, not recruiting

Neurology Consultants of Dallas; Research Department
Dallas Texas 75243 Active, not recruiting

University Hills Clinical Research
Irving Texas 75062 Withdrawn

Wasatch Clinical Research, LLC
Salt Lake City Utah 84107 Active, not recruiting

University of Virginia
Charlottesville Virginia 22906 Active, not recruiting

Sentara Neurology Specialists
Norfolk Virginia 23507 Active, not recruiting

Neurological Associates, Inc.
Richmond Virginia 23229 Completed

National Clinical Research Inc.-Richmond
Richmond Virginia 23294 Active, not recruiting

Northwest Clinical Research Center
Bellevue Washington 98007 Withdrawn

UW Wisconsin-Madison
Madison Wisconsin 53705 Active, not recruiting

Alpha Recherche Clinique
Quebec G3K 2P8 Active, not recruiting

The Med Arts Health Rsrch Grp
Kelowna British Columbia V1Y 3G8 Withdrawn

Medical Arts Health Research Group
Penticton British Columbia V1Y 1Z9 Active, not recruiting

The Medical Clinic Associates
Powell River British Columbia V8A 3B6 Withdrawn

Vancouver Hospital - UBC Hospital Site
Vancouver British Columbia V6Z 1Y6 Withdrawn

The Medical Arts Health Research Group - West Vancouver
Vancouver British Columbia V7T 2Z3 Active, not recruiting

Vancouver Island Health Authority
Victoria British Columbia V8R 1J8 Withdrawn

True North Clinical Research-Halifax
Halifax Nova Scotia B3S 1M7 Withdrawn

Parkwood Hospital; Geriatric Medicine
London Ontario N6C 5J1 Active, not recruiting

Centre for Memory and Aging
Toronto Ontario M4G 3E8 Completed

Sunnybrook Health Sciences Centre
Toronto Ontario M4N 3M5 Active, not recruiting

St. Michael'S Hospital
Toronto Ontario M5B 1W8 Active, not recruiting

Toronto Western Hospital
Toronto Ontario M5T 2S8 Withdrawn

Baycrest Health Sciences
Toronto Ontario M6A 2E1 Active, not recruiting

Devonshire Clinical Research
Woodstock Ontario N4S 5P5 Active, not recruiting

Center for Diagnosis and Research on Alzheimer's disease
Greenfield Park Quebec J4V 2J2 Active, not recruiting

Institute Universitaire de Geriatrie de Montreal
Montréal Quebec H3W 1W5 Withdrawn

CHA Hopital de I enfant-Jesus
Quebec City Quebec G1J 1Z4 Withdrawn

Q & T Research Sherbrooke
Sherbrooke Quebec J1J 2G2 Terminated

Royal University Hospital
Saskatoon Saskatchewan S7N 0W8 Withdrawn

Hoffmann-La Roche

Name Phone Email
Reference Study ID Number: WN29922 www.roche.com/about_roche 888-662-6728 (U.S. and Canada) Global-Roche-Genentech-Trials@gene.com

NCT03444870

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease