Forty years of Alzheimer’s research in Rochester are now feeding into treatment for patients across upstate and western New York, alongside studies testing whether intervention before memory symptoms could help.
The University of Rochester’s AD-CARE program has participated in more than 350 trials since its founding in 1986, according to a Nov. 5 university feature. Its Biologics Treatment Center now treats more than 100 patients with early symptomatic disease.
Treatment requires an individual evaluation
The Biologics Treatment Center offers lecanemab, sold as Leqembi, and donanemab, sold as Kisunla, to eligible patients. The medications target amyloid, a protein that accumulates in the brain, to slow decline in early Alzheimer’s disease. They do not restore lost memory or cure the disease.
A diagnosis alone does not establish eligibility. The center requires confirmation through an Alzheimer’s biomarker and a specialist’s evaluation. Patients who already have an amyloid PET scan, cerebrospinal fluid testing or a P-Tau217 blood test may qualify for a more direct specialist consultation.
During that process, clinicians review the person’s history, the potential benefits and risks, and the monitoring required during treatment. The center’s patient information describes this as an individualized decision involving the patient and care partners.
Safety monitoring matters because anti-amyloid treatment can cause brain swelling and bleeding. The FDA’s donanemab prescribing information carries a boxed warning about these amyloid-related imaging abnormalities, known as ARIA. They can occur without symptoms but can also be serious or fatal.
The label calls for MRI monitoring and highlights greater risk in people with two copies of the APOE4 gene variant. Genetic testing and discussion of its implications are part of assessing that risk. Kisunla is intended to be started in people with mild cognitive impairment or mild dementia from Alzheimer’s disease, the population studied in its clinical trials.
Prevention remains a research question
Rochester also participates in AHEAD 3-45, which tests lecanemab before cognitive symptoms. Two additional prevention studies are planned for later this year, including one involving investigational trontinemab and its Brainshuttle delivery technology.
The AHEAD trial description identifies a randomized, double-blind comparison with placebo. Its purpose is to find out whether treating people with amyloid buildup but normal cognition changes later outcomes. Participation is not the same as receiving an established preventive treatment.
The study includes adults ages 55 to 80, with additional risk requirements for those ages 55 to 64. Those requirements can include a close family history of dementia before age 80, an APOE4 variant or previously documented amyloid buildup.
Participants undergo cognitive testing and PET imaging. The trial separates intermediate and elevated amyloid levels and follows outcomes over roughly four years. A study partner must have regular contact with the participant and help supply information during follow-up.
Research extends beyond amyloid
Rochester researchers are also studying immune cells, sex differences, longevity genes and memory networks in mice. Kerry O’Banion and Vera Gorbunova examine resilience-related genes; Kuan Hong Wang studies the frontal-insular network; Neta Rosenzweig investigates APOE-related immune interactions.
University of Rochester Medical Center
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Neurologist David Gill is starting a Healthy Brain Aging Program for people with normal cognition who may be at risk. Small groups will focus on physical activity, social contact, mental challenges and heart-healthy eating. The Baker family foundation supports the program in Natalie Baker’s memory.
AD-CARE’s research history also includes studies of depression and agitation in dementia, along with work to improve diagnostic techniques, imaging and clinical assessment. That gives the program a broader scope than trials aimed at memory decline alone.
The program’s clinical research involves Rochester, the Finger Lakes and surrounding communities. Its current research information includes prevention studies, early memory changes and diagnostic tools. Study requirements vary, and participation depends on the particular protocol.
AD-CARE can be reached at 585-602-5200 or adcare@urmc.rochester.edu. Its office is at 315 Science Parkway, Entrance A, Suite 100, in Rochester. The Biologics Treatment Center’s number is 585-273-5454.
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