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Safety and Efficacy of Gantenerumab for Early Alzheimer's

Recruiting

This Phase III clinical trial will evaluate the safety and efficacy of gantenerumab in people with early-stage Alzheimer's disease. This trial is similar to Gantenerumab for Early Alzheimer's Disease, but recruiting in different locations.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years All No
June 6, 2018
November 3, 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

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. 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
Banner Alzheimer's Institute
Phoenix Arizona 85006 Active, not recruiting

Barrow Neurological Institute
Phoenix Arizona 85013 Active, not recruiting

Noesis Pharma Clinical Trials
Phoenix Arizona 85032 Withdrawn

Mayo Clinic
Scottsdale Arizona 85259 Withdrawn

Banner Sun Health Research Insitute
Sun City Arizona 85351 Active, not recruiting

University of Arizona
Tucson Arizona 85724-5030 Withdrawn

Health Initiatives Research, PLLC
Fayetteville Arkansas 72703 Active, not recruiting

Fullerton Neurology and Headache Center
Fullerton California 92835 Active, not recruiting

Neurology Center of North Orange County
Fullerton California 92835 Active, not recruiting

Behavioral Research Specialists, LLC
Glendale California 91206 Withdrawn

Irvine Center for Clinical Research
Irvine California 92614 Active, not recruiting

UCLA - School of Medicine, VA Medical Center
Los Angeles California 90073 Withdrawn

Pacific Neuroscience Med Grp
Oxnard California 93030 Withdrawn

Desert Valley Research
Redlands California 92374 Active, not recruiting

Pacific Research Network - PRN
San Diego California 92103 Withdrawn

San Francisco Clinical Research Center
San Francisco California 94109 Withdrawn

Southern California Research LLC
Simi Valley California 93065 Active, not recruiting

Collaborative Neuroscience Network Inc.
Torrance California 90502 Withdrawn

Associated Neurologists of Southern CT PC
Fairfield Connecticut 06824 Withdrawn

Yale University School Of Medicine
New Haven Connecticut 06510 Active, not recruiting

Christiana Care Swank Memory Care Center
Wilmington Delaware 19801 Withdrawn

Georgetown University Medical Center
Washington District of Columbia 20007 Active, not recruiting

Global Medical Institues, LLC; Boynton Beach Medical Research Institute
Boynton Beach Florida 33437 Withdrawn

Meridien Research
Bradenton Florida 34201 Active, not recruiting

Meridien Research
Brooksville Florida 34601 Withdrawn

Neuropsychiatric Research; Center of Southwest Florida
Fort Myers Florida 33912 Withdrawn

ClinCloud, LLC
Maitland Florida 32751 Recruiting

Optimus U Corp
Miami Florida 33125 Recruiting

Allied Biomedical Research Institute, Inc
Miami Florida 33155 Recruiting

Renstar Medical Research
Ocala Florida 34470 Active, not recruiting

Sensible Healthcare; Ocoee, FL
Ocoee Florida 34761 Withdrawn

Progressive Medical Research
Port Orange Florida 32127 Active, not recruiting

Intercoastal Medical Group
Sarasota Florida 34232 Active, not recruiting

Infinity Clinical Research, LLC
Sunrise Florida 33351 Active, not recruiting

Axiom Clinical Research of Florida
Tampa Florida 33609 Recruiting

Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
Tampa Florida 33613 Withdrawn

Emory University
Atlanta Georgia 30329 Active, not recruiting

Augusta University
Augusta Georgia 30912 Withdrawn

iResearch Atlanta
Decatur Georgia 30030 Withdrawn

Rush Alzheimer's Disease Cntr.
Chicago Illinois 60612 Active, not recruiting

Chicago Research Center, Inc.
Chicago Illinois 60634 Withdrawn

Heathcare Research Network II, LLC
Flossmoor Illinois 60422 Withdrawn

Advocate Lutheran General Hospital
Park Ridge Illinois 60068 Withdrawn

American Health Network Institute, LLC
Avon Indiana 46123 Active, not recruiting

University of Kansas Medical Centre
Kansas City Kansas 66160 Withdrawn

Conduct Clinical Trials; Psychiatry Associates of Kansas City
Leawood Kansas 66206 Withdrawn

University of Kentucky
Lexington Kentucky 40536 Withdrawn

Four Rivers Clinical Research Inc.
Paducah Kentucky 42003 Withdrawn

Acadia Hospital
Bangor Maine 04401 Withdrawn

University of Maryland Clinical Neurobehavioral Center
Columbia Maryland 21045 Withdrawn

Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
Boston Massachusetts 02115 Active, not recruiting

ActivMed Practices and Research
Haverhill Massachusetts 01830 Active, not recruiting

Boston Center for Memory
Newton Massachusetts 02459 Active, not recruiting

Quest Research Institute
Farmington Hills Michigan 48334 Recruiting

Missouri Memory Center
Bolivar Missouri 65613 Active, not recruiting

St Louis University Hospital
Saint Louis Missouri 63104 Withdrawn

Washington University School of Medicine
Saint Louis Missouri 63110 Active, not recruiting

University of Nebraska Medical Center; Dept of Neurological Sciences
Omaha Nebraska 68198-8440 Active, not recruiting

Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas Nevada 89106 Active, not recruiting

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

The Cognitive and Research Center of New Jersey
Springfield New Jersey 07081 Active, not recruiting

NJ Institute for Successful Aging
Stratford New Jersey 08084 Withdrawn

Integrative Clinical Trials LLC
Brooklyn New York 11229 Withdrawn

Pioneer Midwood
Brooklyn New York 11229 Withdrawn

UNiversity of Rochester
Rochester New York 14620 Active, not recruiting

Richmond Behavioral Associates
Staten Island New York 10312 Active, not recruiting

SUNY Upstate Medical University
Syracuse New York 13210 Active, not recruiting

Behavioral Health Research
Charlotte North Carolina 28211 Active, not recruiting

Guilford Neurologic Associates
Greensboro North Carolina 27401 Withdrawn

Alzheimer's Memory Center
Matthews North Carolina 28105 Recruiting

Raleigh Neurology Associates
Raleigh North Carolina 27607-6520 Recruiting

Wake Forest University
Winston-Salem North Carolina 27157 Recruiting

University Hospitals Brain Health & Memory Center
Beachwood Ohio 44122 Withdrawn

Neuro-Behavioral Clinical Research, Inc.
Canton Ohio 44718 Completed

Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health - Neurological Institute
Cleveland Ohio 44195 Recruiting

Lynn Health Science Institute
Oklahoma City Oklahoma 73112 Completed

Oklahoma Clinical Research
Oklahoma City Oklahoma 73112 Withdrawn

Summit Research Network Inc.
Portland Oregon 97210 Active, not recruiting

Lehigh Center Clinical Research
Allentown Pennsylvania 18104 Withdrawn

University of South Carolina School of Medicine
Columbia South Carolina 29203-7606 Withdrawn

BG Neurology, LLC
Spartanburg South Carolina 29307 Withdrawn

Texas Neurology PA
Dallas Texas 75206 Active, not recruiting

Kerwin Medical Center
Dallas Texas 75231 Active, not recruiting

The University of Texas Southwestern Medical Center at Dallas
Dallas Texas 75390 Withdrawn

Shepherd Healthcare
Flower Mound Texas 75028 Withdrawn

Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston Texas 77030 Active, not recruiting

The University of Texas Health Science Center at Houston
Houston Texas 77054 Active, not recruiting

University of Texas Health Sciences Center in San Antonio
San Antonio Texas 78229 Withdrawn

Aspen Clinical Research
Orem Utah 84058 Withdrawn

Core Clinical Research
Everett Washington 98201 Withdrawn

Seattle Institute for Biomedical & Clinical Research
Seattle Washington 98108 Withdrawn

Kingfisher Cooperative
Spokane Washington 99202 Withdrawn

Unidad de investigacion en salud (UIS); Neurociencias
Ciudad de México 14050 Withdrawn

Hospital Angeles Culiacan; Neurociencias
Culiacan 80020 Active, not recruiting

Mexico Centre for Clinical Research
Mexico 03100 Active, not recruiting

Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta
Monterrey 64460 Active, not recruiting

AVIX Investigación Clínica S.C
Monterrey 64710 Active, not recruiting

Hospital Español; Servicio de Nuerologia
Ciudad de México Mexico CITY (federal District) 11550 Withdrawn

Grupo Medico de Investigacion Clinica Multidisciplinaria
Mexico City Mexico CITY (federal District) 03100 Withdrawn

Hoffmann-La Roche

Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche

NCT03443973

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