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AHEAD Study: BAN2401 for People With Increased Risk of Alzheimer's Disease

Recruiting

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, BAN2401, reduces brain amyloid buildup in people with increased risk of Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 80 Years All Yes
July 13, 2020
October 25, 2027
1400

General Inclusion Criteria:

  • Participants who are 55 to 64 years of age must have one of the following risk factors for Alzheimer's disease:
    • First degree relative (a parent, brother, sister, or child) diagnosed with dementia before age 75, or
    • Known to have at least one apolipoprotein E4 variant (APOE4) allele, or
    • Known before screening to have elevated brain amyloid according to previous PET or cerebrospinal fluid (CSF) testing
    • Individuals with past amyloid PET scans showing intermediate brain amyloid are eligible to be screened for this study, as long as the participant did not participate in any clinical studies involving anti-amyloid therapies after the PET scan
  • Have not been diagnosed with Alzheimer's disease or another dementia
  • Have elevated or intermediate levels of amyloid in their brains determined by brain imaging as part of the study screening
  • Have a close friend or relative who can serve as a study partner. This person must have weekly contact with the participant by phone, in-person, or email. The study partner must have enough contact such that the study contact believes they can provide meaningful information about the participant's daily function.
  • Able to provide written informed consent and follow all requirements of the study.
  • Global Clinical Dementia Rating (CDR) score of 0
  • Mini-Mental State Examination score greater than or equal to 27 (with educational adjustments)
  • Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score of 6

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

  • Women who are breastfeeding or pregnant
  • Women of childbearing potential who, within 28 days before study entry, did not use a highly effective method of contraception
  • History of transient ischemic attacks (TIAs), stroke, or seizures within 12 months of screening
  • Current, or history within the past two years, of psychiatric diagnosis or symptoms that, in the opinion of the study contact, could interfere with study procedures
  • Ineligible for magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, metal implants, or having had other significant abnormal findings on brain MRI
  • Hypersensitivity to any monoclonal antibody treatment
  • Any immunological disease that is not well-managed, or that requires treatment with immunoglobulins, monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis (a process that filters the blood) during the study
  • Bleeding disorder that is not under adequate control (including a platelet count <50,000 or international normalized ratio [INR] >1.5) at screening
  • Results of laboratory tests conducted during study screening that are outside the following limits:
    • Thyroid stimulating hormone (TSH) above normal range
    • Vitamin B12 levels below normal range, unless other tests (homocysteine and methylmalonic acid levels) shows that it is not physiologically significant.
  • Positive for human immunodeficiency virus (HIV)
  • Malignant tumor growth within three years of study screening (except for basal or squamous cell carcinoma of the skin or localized prostate cancer in male participants with treatment cycles completed at least six months before screening)
  • Risk of suicide based on responses to the Columbia-Suicide Severity Rating Scale (C-SSRS), any suicidal behavior assessment within six months before study screening or the start of the study, or hospitalization or treatment for suicidal behavior in the past five years
  • Known or suspected history of drug or alcohol abuse or dependence within two years before study screening or a positive urine drug test at screening. Participants who test positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug testing may not be excluded unless, in the clinical opinion of the investigator, this is due to potential drug abuse
  • Taking any prohibited or illegal medications
  • Participation in another clinical study involving:
    • Any therapeutic monoclonal antibody protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within six months before screening (anti-amyloid therapies within one year before screening), unless it can be documented that the participant only received the placebo or never received the study therapy
    • Any experimental drug for Alzheimer's disease within six months before study screening unless it can be documented that the participant received only a placebo or never received the study drug
    • Any other experimental drug or device study in the eight weeks or five half-lives of the drug the time it takes for a drug to be inactive in the body (whichever is longer) before the start of this study unless it can be documented that the participant was in a placebo treatment group
  • Planned surgery which will require general anesthesia to occur during the screening phase of this study or within three months of study group assignment
  • Any other health issues that in the opinion of the study contact will require further medical attention or treatment or may interfere with study procedures or safety

For older adults with increased risk of developing Alzheimer's disease, amyloid plaques can begin to form in the brain before there are any symptoms of cognitive decline.This study will determine whether treatment with the study drug, known as BAN2401, can lower the amount of amyloid in the brain and how that affects memory loss due to Alzheimer's disease.

The AHEAD study is comprised of two different trials testing the same experimental drug, BAN2401. Study participants are enrolled in one of two AHEAD trials based on whether they have intermediate or elevated levels of amyloid in their brain:

  • Participants with intermediate amyloid levels take part in the AHEAD A-3 trial
  • Participants with elevated amyloid levels take part in the AHEAD A-45 trial

Over the course of the study, the two different trial groups will receive intravenous (IV) injections of 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, to look at amyloid and another protein, tau, in the brain. The PET scan takes pictures of participants brains, allowing researchers to see and track changes in amyloid and tau levels.

For more information about this study, visit the AHEAD study website.

Name City State Zip Status Primary Contact
University of South Florida - Health Byrd Alzheimer Institute
Tampa Florida 33613 Recruiting Kelly Rodrigo
813-974-4904
blackmer@usf.edu
University of Kentucky
Lexington Kentucky 40504 Recruiting Shoshana Bardach
859-323-1331
shbardach@uky.edu
Butler Hospital Memory and Aging Program
Providence Rhode Island 02906 Recruiting Diane Monast
401-455-6403
dmonast@butler.org

Eisai Inc.

  • Alzheimer’s Clinical Trial Consortium (ACTC)
  • Biogen
  • National Institute on Aging (NIA)

Name Phone Email
Eisai Medical Information 888-274-2378 esi_medinfo@eisai.com
ACTC Recruitment Unit ahead-participate@usc.edu

NCT04468659

AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With E