Start:
July 13, 2020
End:
October 25, 2027
Enrollment:
1400
During the early stages of Alzheimer's disease, amyloid protein forms plaques in the brain. The AHEAD Study is a Phase 3 clinical trial that will test whether the study drug, lecanemab (BAN2401), reduces brain amyloid buildup in people with increased risk of Alzheimer's disease. Study participants will be enrolled in one of two AHEAD trials based on whether they have intermediate or elevated levels of amyloid in their brain. Both trial groups will receive intravenous injections of lecanemab (BAN2401) or a placebo every two weeks for 96 weeks, then every four weeks through 216 weeks. At different points in the study, participants will have a positron emission tomography (PET) brain scan. A PET scan takes pictures of the brain, allowing researchers to see and track changes in the amount of amyloid and tau in a participants brain.
Minimum Age: 55 Years
Maximum Age: 80 Years
General Inclusion Criteria:
In addition, participants will be assigned to one of two trials based on the following criteria:
A-3 Trial Participants: Meets all of the general inclusion criteria plus the presence of intermediate levels of brain amyloid pathology by amyloid PET scan, defined as approximately 20 to 40 Centiloids on study screening scan
A-45 Trial Participants: Meets all of the general inclusion criteria plus the presence of elevated brain amyloid pathology by amyloid PET scan, defined as approximately greater than (>) 40 Centiloids on study screening scan
Who Is the General Study Contact?
To learn more about participating, call 888-274-2378 or email: esi_medinfo@eisai.com or ahead-participate@usc.edu or visit the AHEAD study website.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Alabama | |
---|---|
University of Alabama at Birmingham
Birmingham,
AL
35233
Recruiting
| |
Arizona | |
Banner Alzheimer's Institute
Phoenix,
AZ
85006
Recruiting
| |
Banner Sun Health Research Institute
Sun City,
AZ
85351
Recruiting
| |
California | |
University of California, Irvine
Irvine,
CA
92697
Recruiting
| |
University of Southern California
Los Angeles,
CA
90033
Recruiting
| |
Hoag Memorial Hospital Presbyterian
Newport Beach,
CA
92663
Recruiting
| |
Stanford University
Palo Alto,
CA
94304
Recruiting
| |
Sharp Neurocognitive Research Center
San Diego,
CA
92123
Recruiting
| |
University of California, San Francisco
San Francisco,
CA
94158
Recruiting
| |
University of California, Davis
Walnut Creek,
CA
94598
Recruiting
| |
Connecticut | |
Yale University School of Medicine
New Haven,
CT
06510
Recruiting
| |
District of Columbia | |
Howard University
Washington,
DC
20060
Recruiting
| |
Georgetown University
Washington,
DC
20057
Recruiting
| |
Florida | |
Brain Matters Research
Delray Beach,
FL
33445
Recruiting
| |
Mayo Clinic Jacksonville
Jacksonville,
FL
32224
Recruiting
| |
Advanced Clinical Research Network
Miami,
FL
33135
Recruiting
| |
Gonzalez MD & Aswad MD Health Sciences
Miami,
FL
33125
Recruiting
| |
Wien Center for Clinical Research
Miami Beach,
FL
33140
Recruiting
| |
Renstar Medical Research
Ocala,
FL
34471
Recruiting
| |
Synexus Clinical Research - Orlando
Orlando,
FL
32806
Recruiting
| |
K2 Medical Research, LLC
Orlando ,
FL
32751
Recruiting
| |
University of South Florida Health - Byrd Alzheimer's Institute
Tampa,
FL
33613
Recruiting
| |
Synexus Clinical Research - The Villages
The Villages,
FL
32162
Recruiting
| |
Alzheimer's Research and Treatment Center
Wellington,
FL
33414
Recruiting
| |
Charter Research
Winter Park,
FL
32792
Recruiting
| |
Georgia | |
Emory University
Atlanta,
GA
30329
Recruiting
| |
Columbus Memory Center, LLC
Columbus,
GA
31909
Recruiting
| |
Illinois | |
Northwestern University
Chicago,
IL
60611
Recruiting
| |
Rush University Medical Center
Chicago,
IL
60612
Recruiting
| |
Indiana | |
Indiana University School of Medicine
Indianapolis,
IN
46202
Recruiting
| |
Kansas | |
University of Kansas
Fairway,
KS
66205
Recruiting
| |
Kentucky | |
University of Kentucky - Sanders-Brown Center on Aging
Lexington,
KY
40504
Recruiting
| |
Maryland | |
Johns Hopkins University
Baltimore,
MD
21224
Recruiting
| |
Massachusetts | |
Brigham and Women's Hospital Center for Alzheimer's Research and Treatment
Boston,
MA
02115
Recruiting
| |
Boston University
Boston,
MA
02118
Recruiting
| |
Headlands Eastern MA, LLC
Plymouth,
MA
02360
Recruiting
| |
Michigan | |
University of Michigan
Ann Arbor,
MI
48109
Recruiting
| |
Minnesota | |
Mayo Clinic, Rochester
Rochester,
MN
55905
Recruiting
| |
Missouri | |
Washington University, St. Louis
St. Louis,
MO
63108
Recruiting
| |
Nevada | |
Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas
Las Vegas,
NV
89106
Recruiting
| |
New Jersey | |
Advanced Memory Research Institute of New Jersey
Tom's River,
NJ
08755
Recruiting
| |
New York | |
Columbia University
New York,
NY
10032
Recruiting
| |
Mount Sinai School of Medicine
New York,
NY
10029
Recruiting
| |
University of Rochester Medical Center
Rochester,
NY
14620
Recruiting
| |
North Carolina | |
Duke Health Center
Durham,
NC
27705
Recruiting
| |
AMC Research, LLC
Matthews,
NC
28105
Recruiting
| |
Wake Forest University Health Sciences
Winston-Salem,
NC
27157
Recruiting
| |
Ohio | |
Case Western Reserve University
Beachwood,
OH
44122
Recruiting
| |
Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland
Cleveland,
OH
44195
Recruiting
| |
Ohio State University
Columbus,
OH
43210
Recruiting
| |
Oklahoma | |
Central States Research, LLC
Tulsa,
OK
74136
Recruiting
| |
Oregon | |
Summit Research Network, Oregon
Portland,
OR
97210
Recruiting
| |
Oregon Health & Science University
Portland,
OR
97239
Recruiting
| |
Pennsylvania | |
Abington Neurological Associates
Abington,
PA
19001
Recruiting
| |
University of Pennsylvania
Philadelphia,
PA
19104
Recruiting
| |
University of Pittsburgh
Pittsburgh,
PA
15213
Recruiting
| |
Keystone Clinical Studies, LLC
Plymouth Meeting,
PA
19462
Recruiting
| |
Rhode Island | |
Butler Hospital
Providence,
RI
02906
Recruiting
| |
Rhode Island Hospital
Providence,
RI
02903
Recruiting
| |
South Carolina | |
Ralph H. Johnson VA Health Care System
Charleston,
SC
29403
Recruiting
| |
Tennessee | |
Vanderbilt University Medical Center
Nashville,
TN
37212
Recruiting
| |
Texas | |
UT Southwestern, Dallas
Dallas,
TX
75390
Recruiting
| |
University of North Texas Health Sciences Center
Fort Worth,
TX
76107
Recruiting
| |
Houston Methodist Neurological Institute
Houston,
TX
77030
Recruiting
| |
Baylor College of Medicine
Houston,
TX
77030
Recruiting
| |
University of Texas Health Sciences Center of San Antonio
San Antonio,
TX
78229
Recruiting
| |
Virginia | |
Eastern Virginia Medical School
Norfolk,
VA
23510
Recruiting
| |
National Clinical Research, Inc.
Richmond,
VA
23294
Recruiting
| |
Washington | |
University of Washington, Alzheimer’s Disease Research Center
Seattle,
WA
98104
Recruiting
| |
VA Puget Sound/Seattle Institute for Biomedical and Clinical Research
Seattle,
WA
98108
Recruiting
| |
Wisconsin | |
University of Wisconsin - Madison Hospital and Health Clinic
Madison,
WI
53792
Recruiting
|
Lead: Eisai Inc.
Collaborator Sponsor
Source: ClinicalTrials.gov ID: NCT04468659
An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health