Rhode Island hospitals are actively recruiting participants to the AHEAD Study, the first clinical trial to test the effect of lecanemab (an investigational antibody) in treating preclinical Alzheimer’s disease. The AHEAD Study is seeking individuals who have a high risk of developing Alzheimer’s disease symptoms as they get older, based on biomarker tests indicating amyloid presence in the brain.
AHEAD Study researchers are aiming to see if lecanemab can help either slow or stop the earliest symptoms associated with preclinical Alzheimer’s disease. Eisai recently announced positive topline results from Clarity AD, a phase 3 study evaluating the safety and effectiveness of lecanemab. Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia (collectively known as early Alzheimer’s disease) with confirmed presence of amyloid pathology in the brain.
There are two trial sites currently enrolling in the state. Researchers at Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center (ADMDC) and Butler Hospital’s Memory and Aging Program (MAP) are currently recruiting participants for the AHEAD Study.
Hospitals are seeking men and women between 55-80 years of age who can provide written consent. They must also be willing to take a simple blood test to ensure they meet screening criteria. If the blood test indicates the person can continue screening, they will have a positron emission tomography (PET) scan of the brain to determine if they have an intermediate or elevated amyloid level. Study participants will receive treatment (investigational treatment or placebo), either monthly or bimonthly, via IV infusion by a trained research nurse at either clinic.
“The Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital is committed to finding not only effective treatments for those living with the disease, but also effective ways to prevent the disease in those who show biological indicators of the disease yet are not experiencing any symptoms, “said Jonathan Drake, MD, ADMDC director and principal site investigator for the AHEAD Study at Rhode Island Hospital. “It is our hope that studies such as the AHEAD Study will demonstrate that intervening early enough could help slow disease progression, ideally making Alzheimer’s a manageable rather than fatal disease.”
“We are hopeful that by reducing the level of amyloid protein in the brain, we can either reduce the progression of Alzheimer’s disease, or even stave off cognitive impairment entirely,” said Meghan C. Riddle, MD, MAP interim director and principal site investigator for the AHEAD Study at Butler Hospital. “The Memory and Aging Program at Butler Hospital is delighted to be part of this groundbreaking era of potential treatments for Alzheimer’s disease, and we are excited about the potential impact that the AHEAD Study may have on the future.”
To learn more about the AHEAD Study, or if you are interested in enrolling, contact:
- Rhode Island Hospital ADMDC, 401-444-0085
- Butler Hospital MAP, 401-455-6402