The Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases, part of The University of Texas Health Science Center at San Antonio (UT Health San Antonio), seeks dementia-free volunteers ages 55 to 80 to enroll in a clinical trial of an investigational antibody. The goal of the AHEAD study is to assess whether IV infusions of the antibody (lecanemab) can delay cognitive decline if administered early, before symptoms begin. Lecanemab reduces levels of amyloid, a protein linked to Alzheimer’s disease.
Lecanemab has sparked some excitement recently and has been covered extensively by the media. A separate Phase III clinical trial, published Nov. 29 in The New England Journal of Medicine, showed that lecanemab slowed cognitive decline and cleared amyloid from the brain in participants with cognitive symptoms due to Alzheimer’s disease. Participants who received lecanemab in this trial more frequently experienced infusion-related reactions and small areas of temporary fluid or blood in the brain (typically with no associated symptoms). AHEAD study participants will be monitored closely for safety, including MRI scans being performed at regular intervals, to check for these potential effects.
The AHEAD study is the first clinical trial to test the effect of this antibody in people who have no cognitive symptoms of Alzheimer’s disease but in whom biomarker tests indicate amyloid is present in the brain. The study is also the first to recruit people as young as 55 who, because of family history and biomarker tests, are at higher risk of developing symptoms of Alzheimer’s as they get older.
“Pathological changes that lead to Alzheimer’s dementia, including the brain accumulation of the toxic protein amyloid, begin many years before the onset of first symptoms. Our goal is to identify asymptomatic individuals in whom this process has already begun, and to treat them with this anti-amyloid medication,” said Arash Salardini, MD, a board-certified behavioral neurologist with the Glenn Biggs Institute. Salardini is the clinical trial’s principal investigator at the Biggs Institute site.
“Our hope is to change the trajectory of their future cognitive health for the better,” Salardini said. “People without any symptoms, aged older than 65, can now be screened using a blood test for amyloid. Persons 55-64 can also participate if they already have evidence of positive amyloid, if they have genetic predisposition to Alzheimer’s disease, or if they have a strong family history. These are the people we want to screen for eligibility to join the AHEAD study.”
AHEAD is a multicenter, randomized, controlled, double-blind clinical study, which means that volunteers are randomly assigned to receive infusions of either lecanemab or a placebo, an inactive substance designed to mimic the appearance of the drug. Neither the participants nor the study personnel knows who is assigned to which group.
AHEAD is a Phase III study that follows earlier Phase I and II studies in volunteers with symptoms of cognitive decline. The new phase expands the assessment of lecanemab to healthy volunteers who have markers of amyloid in the brain. “Basically, since Alzheimer’s disease begins 10 to 20 years before someone has their first symptoms, Phase III aims to remove the amyloid protein from the brain very early to avoid, or at least reduce, the accumulation of irreversible damage to the brain,” Salardini said.
Volunteers will gain the benefit of free, early screening. Enrollment in the study will be at the discretion of a Biggs Institute neurologist.
“If you are older than 65 years of age and are cognitively normal, you may be interested in the screening and enrollment in our trial,” Salardini said. “If you are between 55 and 64 and have a first-degree relative who was diagnosed with Alzheimer’s before age 75 and meet other study criteria, you can be enrolled and receive the screening.”
The Glenn Biggs Institute, in partnership with The University of Texas Rio Grande Valley, is a National Institute on Aging-Designated Alzheimer’s Disease Research Center (ADRC). This is the only ADRC in the state of Texas and one of 33 nationwide.
“We are one of the 33 leading Alzheimer’s disease centers in the country, and we have many ongoing clinical trials,” Salardini said.
The South Texas ADRC is a leading center for the recruitment of Hispanics into clinical studies, and while all ethnicities are welcomed for the AHEAD study, the inclusion of Hispanics in the study is vitally important for what can be learned, Salardini said.
More information about the AHEAD study is available on the Glenn Biggs Institute website. This page contains a list of eligibility criteria and a YouTube video introduction to the study. To inquire about screening for the trial, contact Amy Saklad, director of research operations, at 210-567-8229 or email@example.com.
The Biggs Institute will soon launch a companion trial, ENVISION, which will evaluate the capacity of a second antibody (aducanumab) to slow the progression of disease in individuals with early symptomatic Alzheimer’s dementia.