Study Details
The AHEAD 3-45 Study is closed for enrollment. Alzheimer’s disease (AD) is a progressive, neurodegenerative disorder characterized by cognitive decline with loss of memory. The biological hallmarks of AD include the buildup of an abnormal form of a protein called amyloid, but not every person with amyloid accumulation will develop memory problems or AD. Amyloid plaques are composed of β-amyloid peptide (Aβ) and research suggest that Aβ can begin to accumulate 10 to 20 years before the onset of clinical symptoms. “Preclinical AD” is defined as the accumulation of amyloid in the brain, before clinical symptoms.
The purpose of the AHEAD study is to determine if an investigational drug (lecanemab) reduces the risk of developing AD dementia through early intervention targeting the amyloid pathway before significant and irreversible neurodegeneration. Lecanemab is a novel humanized immunoglobulin G1 (IgG1) monoclonal antibody that preferentially binds to Aβ protofibrils. This study includes a 216-week treatment period (about 4 years) with an optional open-label extension phase for participants with Preclinical AD. Participants will receive either monthly or bi-weekly depending on their treatment arm (A3 vs. A45). Throughout the study longitudinal cognitive, clinical, safety, fluid biomarker, and imaging biomarker assessments will be performed. https://www.aheadstudy.org/about/ Only individuals aged 55-80 who have intermediate or elevated levels of amyloid in their brain will be able to participate in these studies. The screening process for the AHEAD Study will use a Positron Emission Tomography (PET) scan to measure the level of amyloid in your brain. Must have a study partner that is willing to participate as a source of information and who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, or caregiver). |