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Crenezumab for Prodromal to Mild Alzheimer's Disease

Active, not recruiting

This clinical trial will test the experimental drug crenezumab in people with early to mild Alzheimer's disease. Investigators will assess the drug's safety and efficacy and evaluate any changes in participants' dementia rating and performance on neuropsychological tests.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years Both No
March 2016
July 2021
750

  • Weight of 40-120 kilograms (88-264 pounds) inclusive
  • Availability of caregiver who can provide accurate information about participant's cognitive and functional abilities, agrees to provide information at clinic visits, and signs consent form
  • Fluent in language of tests used at the study site
  • Adequate seeing and hearing ability to perform neuropsychological testing (eyeglasses and hearing aids are permitted)
  • Evidence of the Alzheimer's disease pathological process, as shown by positive amyloid
  • Abnormal memory function at screening; Mini-Mental State examination score of 22 or higher
  • Clinical Dementia Rating-Global Score of 0.5 or 1.0
  • Meets National Institute on Aging/Alzheimer's Association core clinical criteria for probable Alzheimer's dementia or prodromal Alzheimer's
  • If taking Alzheimer's medication, dose must be stable for at least 3 months prior to screening

  • Evidence of condition other than Alzheimer's that may affect cognition, such as other dementias, stroke, brain damage, autoimmune disorders, or certain infections
  • History of major psychiatric illness such as schizophrenia or major depression
  • At risk of suicide
  • Significant cerebral vascular pathology as assessed by magnetic resonance imaging
  • Unstable or clinically significant cardiovascular, kidney, or liver disease
  • Uncontrolled hypertension
  • Screening hemoglobin A1c (HbA1C) of >8 percent
  • Poor peripheral venous access
  • History of cancer except if considered to be cured or, if not, being actively treated with anti-cancer therapy or radiotherapy
  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins

In this Phase III trial, participants will be randomly assigned to take either the study drug or a placebo, administered as an IV infusion every 4 weeks, for 100 weeks (a little more than 2 years). Crenezumab is a humanized monoclonal antibody that acts on beta-amyloid, a toxic protein fragment found in the brains of people with Alzheimer's disease.

For more information about this clinical trial, contact Hoffman-LaRoche Clinical Trials at 888-662-6728 (U.S. and Canada) or global-roche-genentech-trials@gene.com.

Name City State Zip Status Primary Contact
Xenoscience
Phoenix Arizona 85004

Banner Alzheimer's Institute
Phoenix Arizona 85006

Barrow Neurological Institute
Phoenix Arizona 85013

Banner Sun Health Research Insitute
Sun City Arizona 85351

American Neuropsychiatric Research Institute Inc
Carson California 90746

Pharmacology Research Inst
Encino California 91316

Alliance for Wellness, dba Alliance for Research
Long Beach California 90807

Pharmacology Research Institute
Los Alamitos California 90720

USC Keck School Of Medicine
Los Angeles California 90033

UCLA Medical Center, Department of Neurology
Los Angeles California 90095

Pharmacology Research Inst
Newport Beach California 92660

Shankle Clinic
Newport Beach California 92663

Stanford Univ Medical Center
Palo Alto California 94304

Anderson Clinical Research, Inc.
Redlands California 92374

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

UCSF - Memory and Aging Center
San Francisco California 94158

Neurological Research Inst
Santa Monica California 90404

North Bay Neuro Science Institute
Sebastopol California 95472

Collaborative Neuroscience Network Inc.
Torrance California 90502

Mile High Research Center
Denver Colorado 80218

Associated Neurologists PC - Danbury
Danbury Connecticut 06810

Institute for Neurodegenerative Disorders
New Haven Connecticut 06510

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

Bradenton Research Center
Bradenton Florida 34205

Quantum Laboratories
Deerfield Beach Florida 33064

Brain Matters Research, Inc.
Delray Beach Florida 33445

Cohen Medical Research Associates, LLC
Delray Beach Florida 33446

Galiz Research, LLC
Hialeah Florida 33016

Jacksonville Center For Clinical Research
Jacksonville Florida 32216

Clinical Neuroscience Solutions Inc; Jacksonville Clinic
Jacksonville Florida 32256

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449

Merritt - Island Medical Research
Merritt Island Florida 32952

Miami Jewish Health Systems
Miami Florida 33137

Renstar Medical Research
Ocala Florida 34470

CNS Healthcare
Orlando Florida 32801

Bioclinica Research
Orlando Florida 32806

Progressive Medical Research
Port Orange Florida 32127

Miami Research Associates
South Miami Florida 33143

Axiom Clinical Research of Florida
Tampa Florida 33609

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

Stedman Clinical Trials, LLC
Tampa Florida 33613

Compass Research
The Villages Florida 32162

Emory University
Atlanta Georgia 30329

NeuroStudies.net, LLC
Decatur Georgia 30033

Alexian Brothers Neurosci Inst
Elk Grove Village Illinois 60007

Southern Illinois University, School of Medicine
Springfield Illinois 62702

Indiana University
Indianapolis Indiana 46202

MidAmerica Neuroscience Institute
Prairie Village Kansas 66206

Maine Research Associates
Auburn Maine 04210

MMP Neurology
Scarborough Maine 04074

Springfield Neurology Associates
Springfield Massachusetts 01104

Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
Kalamazoo Michigan 49008

Precise Research Centers
Flowood Mississippi 39232

Millennium Psychiatric Associates, LLC
Creve Coeur Missouri 63141

Las Vegas Medical Research
Las Vegas Nevada 89113

The Cognitive and Research Center of New Jersey
Springfield New Jersey 07081

Advanced Memory Research Institute of NJ
Toms River New Jersey 08755

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

Albuquerque Neuroscience Inc.
Albuquerque New Mexico 87109

Albany Medical Faculty Physicians COmmunity Division. The Neurology Group
Albany New York 12206

Neurological Associates of Albany, PC
Albany New York 12298

Columbia University Medical Center
New York New York 10032

South Shore Neurologic Associates P.C.
Patchogue New York 11772

Dent Neurological Institute
Williamsville New York 14221

Behavioral Health Research
Charlotte North Carolina 28211

Alzheimer's Memory Center
Charlotte North Carolina 28270

Guilford Neurologic Associates
Greensboro North Carolina 27401

Valley Medical Primary Care
Centerville Ohio 45459

UC Health Neurology
Dayton Ohio 45417

Insight Clinical Trials LLC
Shaker Heights Ohio 44122

Oklahoma Clinical Research
Oklahoma City Oklahoma 73112

Cutting Edge Research Group
Oklahoma City Oklahoma 73116

Tulsa Clinical Research LLC
Tulsa Oklahoma 74104

Summit Research Network Inc.
Portland Oregon 97210

Neural Net Research; Neural Net Research
Portland Oregon 97225

Drexel Univ College of Med; Clinical Research Group
Philadelphia Pennsylvania 19102

Abington Neurological Associates
Willow Grove Pennsylvania 19090

Roper Hospital Laboratory
Charleston South Carolina 29403

Vanderbilt University Medical Center
Nashville Tennessee 37232

Senior Adults Specialty Research
Austin Texas 78757

Texas Alzheimer's and Memory Disorders
Dallas Texas 75214

University of North Texas Health Science Center; Fort Worth Patient Care Center
Fort Worth Texas 76107

Radiant Research, Inc.
Salt Lake City Utah 84123

Sentara Medical Group
Norfolk Virginia 23507

National Clinical Research Inc.-Richmond
Richmond Virginia 23294

Medical College of Wisconsin
Milwaukee Wisconsin 53226

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

Vancouver Island Health Authority
Victoria British Columbia V8R 1J8

Parkwood Hospital; Geriatric Medicine
London Ontario N6C 5J1

Bruyere Continuing Care
Ottawa Ontario K1N 5C8

Kawartha Centre - Redefining Healthy Aging
Peterborough Ontario K9H 2P4

The Centre for Memory and Aging
Toronto Ontario M4G 3E8

Toronto Western Hospital
Toronto Ontario M5T 2S8

Devonshire Clinical Research Inc.
Woodstock Ontario N4S 5P5

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

Diex Recherche Sherbrooke
Sherbrooke Quebec J1H 1Z1

Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Culiacan 80020

Hospital Uni; Dr. Jose E. Gonzalez
Monterrey 64460

AVIX Investigación Clínica S.C
Monterrey 64710

Hospital Universitario de Saltillo
Saltillo 25000

Hoffmann-La Roche

Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche

Name Phone Email
Hoffman-LaRoche 888-662-6728 global-roche-genentech-trials@gene.com

NCT02670083

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease