A new study will combine an Alzheimer's medication that slows disease progression in some patients with two other drugs to see if their effects can be amplified. The trial will be the first to test drugs acting on two disease-driving proteins, amyloid and tau, for patients with late-onset Alzheimer's, the most common type of dementia.
The trial will recruit 900 participants with early Alzheimer's at UC San Francisco and other sites nationwide. It is funded by a $151 million grant from the National Institute on Aging, part of the National Institutes of Health.
The grant is awarded to Adam Boxer, MD, PhD, principal investigator and project leader of the trial, and endowed professor in memory and aging in the Department of Neurology at UCSF. It is co-led by Keith Johnson, MD, professor of radiology and neurology at the Harvard Medical school.
In the trial, known as the Alzheimer's Tau Platform (ATP), researchers will evaluate the effects of two anti-tau therapies and an anti-amyloid therapy like lecanemab (Leqembi), which was approved in January 2023 after demonstrating a 27% reduction in global impairment compared with placebo.
Lecanemab and related drugs clear amyloid and have also been shown to reduce tau. But drugs that specifically target tau may be more effective since their levels and locations correlate more closely with symptoms.
Multiple meds may create synergistic effect
"The ATP trial represents the next era in Alzheimer's treatment developments, since it will use a combination of therapies that may have additive or synergistic effects," said Boxer, who is also director of the UCSF Alzheimer's Disease and Frontotemporal Dementia Clinical Trials Program and director of the Neurosciences Clinical Research Unit. "In addition to potentially better clinical results, this treatment approach is constructed on a novel, more efficient clinical trial design."
Final details of the trial are pending, but researchers will likely recruit participants aged 60 or older with asymptomatic Alzheimer's or mild cognitive impairment, confirmed by tau blood tests, PET scans and cognitive testing.
