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JNJ-54861911 in Older Adults at Risk for Alzheimer's (EARLY)

Start: November 2015
End: April 2024
Enrollment: 1650

What Is This Study About?

This multi-site study, known as the EARLY trial, will evaluate the effect of experimental drug JNJ-54861911 on memory and cognitive function in older adults who are at risk for developing Alzheimer's disease but don't show any symptoms. 

Do I Qualify To Participate in This Study?

Minimum Age: 60 Years

Maximum Age: 85 Years

Must have:

  • Clinical Dementia Rating score of 0
  • Evidence of amyloid accumulation, as shown by levels in cerebrospinal fluid (CSF) or positron emission tomography (PET) scan 
  • Participants 60 to 64 years old must also have one of the following:
    • Family history of dementia (minimum of one first-degree relative)
    • Previously known 4 allele (APOE 4) genotype
    • Previously known biomarker status demonstrating elevated amyloid accumulation in CSF or PET scan
  • Able to read and write
  • Adequate hearing and visual ability to complete tests and assessments
  • Medically stable with or without medication

Must NOT have:

  • Taking Alzheimer's medication (acetylcholinesterase inhibitor and/or memantine) at any time during screening or study start
  • Evidence of any brain disease or abnormality, including large strokes, that could explain possible cognitive deficit
  • Dementia or brain disorder that can cause dementia
  • Inability to undergo MRI because of prostheses, implants, claustrophobia, pacemaker, or other reason
  • Evidence of early-onset familial Alzheimer's disease

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

For more information about the EARLY trial or study sites, call 1-844-903-2759, or visit www.earlytrial.com.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Alabama
University of Alabama, Birmingham
Birmingham, AL 35294
Recruiting
Lynn Merritt
Arizona
Banner Alzheimer's Institute
Phoenix, AZ 85006
Recruiting
Sachin Pandya
Barrow Neurological Institute
Phoenix, AZ 85013
Recruiting
George Thomas
Banner Sun Health Research Institute
Sun City, AZ 85351
Recruiting
Justin Ford
California
University of Southern California, Rancho Park
Downey, CA 90242
Recruiting
Stephanie Bughi
University of California, Irvine
Irvine, CA 92868
Recruiting
Beatriz Yanez
University of California, San Diego
La Jolla, CA 92037
Recruiting
Nana Kori
University of California, Los Angeles
Los Angeles, CA 90095
Not yet recruiting
Celine Ossinalde
Hoag Neurological Institute
Newport Beach, CA 92663
Recruiting
Laura Heim
Sharp Mesa Vista Hospital
San Diego, CA 92123
Recruiting
Mark Dobrina
Connecticut
Yale University School of Medicine
New Haven, CT 06510
Recruiting
Carol Gunnoud
District of Columbia
Georgetown University
Washington, DC 20007
Recruiting
Kianna Harris
Florida
Florida Atlantic University
Boca Raton, FL 33431
Not yet recruiting
Mary Lou Riccio
Brain Matters Research
Delray Beach, FL 33445
Recruiting
Jetliza Lesmes
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
Recruiting
Jessica Bur
Jacksonville Center For Clinical Research
Jacksonville, FL 32216
Recruiting
Mayo Clinic, Jacksonville
Jacksonville, FL 32224
Recruiting
Cristin Williams
Alzheimers Research and Treatment Center
Lake Worth, FL 33449
Recruiting
Bioclinica Research, Melbourne
Melbourne, FL 32940
Recruiting
Liz Gorman
Wien Center for Clinical Research
Miami Beach, FL 33140
Recruiting
Rosemarie Rodriguez
Sensible Healthcare
Ocoee, FL 34761
Recruiting
Jessica Branning
Bioclinica Research, Orlando
Orlando, FL 32806
Recruiting
Jennifer Trotter
Neurology Associates of Ormond Beach
Ormond Beach, FL 32174
Recruiting
Tara Davison
University of South Florida - Health Byrd Alzheimer Institute
Tampa, FL 33613
Recruiting
Ijeoma Mba
Bioclinica Research, North
The Villages, FL 32162
Recruiting
Joleen Smith
Georgia
Emory University
Atlanta, GA 30322
Recruiting
Deborah Westover
Medical Research and Health Education Foundation
Columbus, GA 31909
Recruiting
Jeannie Pierson
NeuroStudies.net, LLC
Decatur, GA 30033
Recruiting
Jennifer Cavin
Illinois
Rush University Medical Center
Chicago, IL 60612
Recruiting
Andleeb Rasheed
Alexian Brothers Neuroscience Research Institute
Elk Grove Village, IL 60007
Recruiting
Reeti Goyal
Indiana
Indiana Medical Research
Elkhart, IN 46514
Recruiting
Kay Stanley
Indiana University
Indianapolis, IN 46202
Recruiting
Ryan Crosbie
Iowa
University of Iowa
Iowa City, IA 52242
Recruiting
Karen Smith
Kansas
University of Kansas
Westwood, KS 66205
Recruiting
Jane Ledmesa
Kentucky
University of Kentucky
Lexington, KY 40504
Recruiting
Louisiana
Pennington Biomedical Research Center
Baton Rouge, LA 70808
Recruiting
Robert Brouilette
Maine
Acadia Hospital and Eastern Maine Medical Center
Bangor, ME 04401
Recruiting
Kathleen Chamberlain
Massachusetts
Brigham and Women's Hospital
Boston, MA 02115
Recruiting
Leah Levine
Boston University
Boston, MA 02118
Recruiting
Claire Thomas
Donald S. Marks, MD, P.C.
Plymouth, MA 02360
Recruiting
Shelby Lydon
Michigan
University of Michigan, Ann Arbor
Ann Arbor, MI 48109
Recruiting
Sarah Brand
Western Michigan University
Kalamazoo, MI 49008
Recruiting
Candace Moore
Mississippi
Hattiesburg Clinic
Hattiesburg, MS 39401
Recruiting
Kayleigh Moring
Missouri
Saint Louis University
Saint Louis, MO 63104
Recruiting
Susan Brown
Washington University, St. Louis
St. Louis, MO 63108
Not yet recruiting
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, NV 89106
Recruiting
Las Vegas Medical Research
Las Vegas, NV 89113
Recruiting
Michelle Sholar
New York
Dent Neurologic Institute
Amherst, NY 14226
Not yet recruiting
Caroline Kumm
Mount Sinai School of Medicine
New York, NY 10029
Recruiting
Emily Lampshire
Nathan Kline Institute for Psychiatric Research
Orangeburg, NY 10962
Recruiting
Raymundo Hernando
University of Rochester Medical Center
Rochester, NY 14620
Recruiting
Melanie Keltz
Richmond Behavioral Associates
Staten Island, NY 10312
Recruiting
Priya Selvarajah
SUNY Upstate Medical University
Syracuse, NY 13210
Recruiting
Muhammad Iqbal
North Carolina
Alzheimer's Memory Center
Charlotte, NC 28270
Not yet recruiting
Hilary Swierz
New Hope Clinical Research
Charlotte, NC 28211
Recruiting
Anelys Marin
Raleigh Neurology Associates
Raleigh, NC 27607
Recruiting
Tracey Pate
Wake Forest Health Sciences
Winston-Salem, NC 27157
Recruiting
Tim Collare
Ohio
Cleveland Clinic
Cleveland, OH 44195
Recruiting
Danielle Kemeny
Oregon
Summit Research Network, Oregon
Portland, OR 97210
Recruiting
Tawnya Andersen
Center for Cognitive Health
Portland, OR 97225
Recruiting
Jamie Naylor
Pennsylvania
University of Pittsburgh
Pittsburgh, PA 15213
Not yet recruiting
Abington Neurological Associates
Willow Grove, PA 19090
Recruiting
Roxanne Dowie
Rhode Island
Rhode Island Hospital
Providence, RI 02903
Recruiting
Justine Bernier
Butler Hospital Memory and Aging Program
Providence, RI 02906
Recruiting
Tara Tang
South Carolina
Roper St. Francis Hospital
Charleston, SC 29401
Recruiting
Allison Lapp
Tennessee
Neurology Clinic, PC
Cordova, TN 38018
Recruiting
Rebecca Sparks
Clinical Research Associates
Nashville, TN 37203
Recruiting
Matthew Schipani
Texas
University of Texas Southwestern Medical Center
Dallas, TX 75390
Not yet recruiting
Erica Adkins
Houston Methodist Neurological Institute
Houston, TX 77030
Recruiting
Jennifer Garrett
Baylor College of Medicine
Houston, TX 77030
Not yet recruiting
Monica Rodriguear
University of Texas Health Science Center, San Antonio
San Antonio, TX 78229
Recruiting
Marsha Polk
Utah
University of Utah
Salt Lake City, UT 84112
Not yet recruiting
Virginia
University of Virginia
Charlottesville, VA 22908
Recruiting
Colleen Webber
Washington
University of Washington, Alzheimer's Disease Research Center
Seattle, WA 98195
Recruiting
Yeung Tutterrow
Northwest Neurological (Drg23, PLLC)
Spokane, WA 99202
Recruiting
Marina Tadros
Wisconsin
University of Wisconsin
Madison, WI 53705
Not yet recruiting
Stephanie Li

Who Sponsors This Study?

Lead: Janssen Research & Development, LLC

Source: ClinicalTrials.gov ID: NCT02569398