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Drug study to examine Alzheimer’s disease prevention, research Michigan participants

An as yet unapproved drug shows promise for reducing cognitive decline in patients with Alzheimer’s disease.

Whether it might work to prevent disease progression is the question in a new clinical trial of lecanemab, a monoclonal antibody developed by Japanese pharmaceutical company Eisai and Biogen of Massachusetts.

Michigan’s only site, at the University of Michigan at Ann Arbor, is looking for participants between the ages of 55 and 80 who have high or intermediate levels of a protein called amyloid in their brains. The initial blood screening will determine the possible presence of amyloid, the buildup of which has been linked to Alzheimer’s disease.

“It’s really an opportunity to get ahead of Alzheimer’s disease. We know it has a huge impact, both in terms of personal toll, emotional toll, and economic toll,” said Dr. Judith Heidebrink of Michigan Medicine, who specializes in Alzheimer’s disease and other dementias. She is the principal investigator of the trial site.

It is impossible to eliminate risk factor n°1: age. Genetic propensity is also inevitable, and by the time people show symptoms, they’ve likely been undergoing biological changes for a decade or more, Heidebrink said.

“So we really want to be able to treat earlier.”

Funded by the National Institutes of Health and a US subsidiary of Tokyo-headquartered Eisai, the trial, called the AHEAD study, has more than 100 sites worldwide and is looking for 1,165 participants from North America. . Heidebrink said it would be ideal to have 10 to 20 attendees in Ann Arbor.

Finding those who are eligible, however, is difficult. Most of those screened do not have the necessary markers.

“Because this is a study of people with early biological changes from Alzheimer’s disease, but absolutely no cognitive impairment, we don’t know who these people are and they don’t know who they are,” said said Heidebrink.

The study boasts of being the first to recruit such a young at-risk population.

To date, trials have focused on people who already have Alzheimer’s disease. A study published this week in the New England Journal of Medicine found that the drug “reduced amyloid markers in early Alzheimer’s disease and caused moderately less decline in measures of cognition and function than the placebo at 18 months, but was associated with adverse events”. Longer trials are warranted, he concludes.

This information came after Eisai reported in a September press release that lecanemab reduced clinical decline on a cognitive and functional scale by 27% compared to those who received a placebo in a study of 1,795 people with early onset of the disease.

The US Food and Drug Administration is due to review lecanemab in January. It has previously endorsed a similar drug, Aduhelm, produced by the same companies, despite conflicting evidence of its effectiveness.

Side effects include possible headaches at the time of the infusion or flushing or chills – “things that can often be managed”. says Heidebrink.

There is also a small risk of fluid buildup or leaking blood vessels in the brain, she said. However, she noted, amyloid alone may be the cause. The recently published study found “amyloid-related imaging abnormalities with edema or effusion” in 12.6% of participants.

In October, health publication Stat reported that the treatment contributed to the death of a participant in the Phase 3 trial. Eisai told Stat that there were other possible factors, including multiple falls , heart attack, respiratory infection, and mini-stroke-like events.

“It was multiple health events that ultimately resulted in death,” Heidebrink said.

An investigation is underway to determine what role the study drug may have played, she said ahead of Thanksgiving.

Science magazine has since reported that a 65-year-old participant died of a massive brain hemorrhage. Some researchers say the drug helped, but Eisai told Science in a statement that all available safety information indicates that lecanemab is not associated with an increased risk of death.

Participants are constantly monitored for the development of any symptoms that could be a side effect, Heidebrink said.

Heidebrink said the research team talks to potential participants about the risks and benefits. Everyone, she says, has a different level of risk tolerance.

Those who might consider participating should also know that the timing is not trivial. Depending on the amount of amyloid accumulated in their brain, people should receive infusions of the drug or a placebo every two to four weeks in Ann Arbor. They also sometimes undergo positron emission tomography or PET brain scans to assess their brain proteins.

Lecanemab interferes with the formation of plaques, abnormal clumps of amyloid, in the brain. These plaques are one of the two main pathologies of Alzheimer’s. Both involved misfolded or mishandled proteins, Heidebrink said.

“So the idea is that we know that the biology starts before the symptoms. If we intervene with the biology, we can prevent the symptoms.

There is currently no cure for Alzheimer’s disease, the most common cause of loss of memory and other cognitive abilities.

It affects approximately 190,000 adults age 65 and older in Michigan and is one of the leading causes of death in the state.

There is no simple reason for illness. A small number of people diagnosed have a genetic mutation, but this is rare. Doctors know that the brain shows plaques and tangles of these proteins. But why and how did they develop?

“It’s a complicated process and we don’t fully understand all the causes and effects of it to be able to target therapies,” Heidebrink said.

Heidebrink said by the time patients came to his Ann Arbor clinic, they had started to decline. “One of the things I always regret is never seeing my patients before they had symptoms, seeing what their life was like before that.”

To learn more about the study, call 1-800-AHEAD-70 or to find an enrollment trial site location, visit For information specific to Ann Arbor, call 734-232-2415.

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