Early-Intervention Alzheimer’s Trial Aims for Ethnic Diversity
Participants Age 65-85 Now Being Recruited at 61 Sites
Harvard researcher Reisa Sperling, MD, thinks it might be possible to prevent or delay the worst symptoms of Alzheimer's when physical changes in the brain, including shrinkage and amyloid build-up, are detected before cognition is impaired and treatment begins at those earliest stages. A 2010-14 BrightFocus grantee, Sperling now heads a major clinical trial to investigate the possibility of early intervention (see our June 20 News Update).
Today she met with the Washington, D.C.-based coalition, Leaders Engaged on Alzheimer’s Disease (LEAD) seeking help in recruiting participants for the A4 Study, which is due to begin in a few months and is recruiting participants aged 65-85 years at 60 sites throughout the U.S. and Canada, and one site in Australia.
She described A4 as "an attempt to intervene at the tipping point," before Alzheimer's begins.
That's the good news Sperling shared today with the LEAD coalition, which includes BrightFocus. She also shared the bad news that Alzheimer's affects ethnic minorities in the U.S., including African Americans and Latinos, up to two times as often as white Americans, according to some studies. That's why the A4 Study team is reaching out to Americans from diverse ethnic groups, and also to more difficult-to-recruit people in older age brackets (age 75 and above) to participate.
The A4 study was spawned from a previous trial testing the Eli Lilly monoclonal antibody, solanezumab, which was not shown to have significant benefit overall, possibly because treatment began too late. There was a subgroup of adults with mild cognitive impairment who did benefit, however.
Thus, for the A4 trial, eligible participants will be screened to see if they're at risk for Alzheimer's due to early brain changes, but they should otherwise be near-normal, from a cognitive standpoint. "They can be worried about getting Alzheimer's, but they shouldn't already have seen a doctor about it," was the way Sperling described it.
One drug, by itself, is unlikely to completely stop the disease, Sperling said, but positive results from the A4 trial may pave the way for clinical trials of additional agents that, when combined, might make early intervention possible.
Sperling was a 2010-14 BrightFocus grantee and her research into amyloid imaging techniques will be put to work in the A4 trial.
Mild cognitive impairment (MCI) is a condition between normal age-related memory loss and dementia. Individuals with MCI have persistent memory problems (for example, difficulty remembering names and following conversations and marked forgetfulness) but are able to perform routine activities without more than usual assistance. Individuals with MCI are at risk of developing Alzheimer's disease or other forms of dementia.
Amyloid is a general term for protein fragments that the body produces normally. Beta amyloid is a protein fragment snipped from an amyloid precursor protein (APP). In a healthy brain, these protein fragments are broken down and eliminated. In Alzheimer's disease, the fragments accumulate to form hard, insoluble plaques.