New drug to prevent Alzheimer's disease enters trial

WHITE PLAINS, N.Y. — The day her mother put a plastic food container in the oven and heated it up was the day Elizabeth Miller knew the elderly woman's increasingly frequent lapses in judgment had progressed to something much worse.

Alzheimer's disease stole her mother, an artist who worked as a secretary, ate well and exercised regularly until her 90s.

"My mother ceased to be my mother," recalled Miller, 66, a retired attorney and artist. "The essence of who she was was destroyed by the disease."

That memory and the desire to avoid the same fate is prompting Miller, a Kingston resident, to undergo tests to see if she can become one of 1,000 people nationwide to try an experimental medication that might be able to help ward off Alzheimer's disease before it happens.

A $140 million study by the National Institutes of Health and the pharmaceutical company Eli Lilly will test the medication, solanezumab, to see if it can prevent the ravages of Alzheimer's, which include memory loss and decline in cognitive function.

"This is the first time we can intervene long before the extreme damage to the brain has been done," said Dr. Nunzio Pomara, a psychiatrist and director of the Geriatric Psychiatry Research Division at the Nathan Kline Institute for Psychiatric Research.

The state-funded facility in Orangeburg is one of 60 nationwide enrolling trial participants.

The trial is also being conducted in New York City at the Mount Sinai School of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center and Columbia University Medical Center.

Pomara said that the Nathan Kline Institute has already been contacted by people throughout the area eager to see if they qualify.

Most have family members, often parents, who have developed Alzheimer's.

"My mother and my grandfather died of Alzheimer's — it's such a terrible disease," said Guy Colaneri, 69, general manager of Mount Kisco Honda, who has also inquired to see if he can take part. "I would love to do something that would help my children, even my grandchildren not get it."

He has reason to worry.

More than 5 million people nationwide have Alzheimer's, which affects one in nine people older than 65 and a third of people age 85 and older, according to the Alzheimer's Association.

As the population ages, the number of people living with Alzheimer's is expected to grow.

A new report by Hudson Valley Pattern for Progress, a not-for-profit policy and research organization, finds the region's hospitals, nursing homes and other health care providers unprepared to meet the demands of the region's aging population, including those with Alzheimer's.

The report recommends creating additional housing options for people with Alzheimer's, including special "memory care" units in hospitals and nursing homes and other forms of supportive housing.

Caring for a person with Alzheimer's is challenging and expensive.

The current cost nationwide is estimated at $214 billion, including $150 billion in expenses paid by Medicare and Medicaid, according to the Alzheimer's Association. It also takes a heavy toll on families, with relatives and friends providing an estimated 17 billion hours of unpaid care worth more than $220 billion, according to the association.

Those costs are expected to grow $1.2 trillion nationwide in 2050.

"If we do not have any treatments, this country and other countries will become bankrupt," Pomara said.

The only treatments currently available work to arrest progression of the illness. The new drug is different because it targets a mechanism thought to cause Alzheimer's before symptoms occur.

Researchers think that Alzheimer's results from a buildup of a protein in the brain called beta-amyloid. The substance forms a sticky plaque in the brain that scientists think is responsible for the disruption in brain function.

But not everyone who has deposits of beta-amyloid in the brain develops Alzheimer's. And those deposits can be present in the brain for a long time before symptoms appear.

That is why researchers want to study people like Elizabeth Miller and Guy Colanari, who have no symptoms of the disease — even if tests, which both would undergo — show they have some plaque buildup.

To be eligible for the three-year study, potential participants between the ages of 65 and 85 have to take sophisticated tests to measure their memory and cognitive skills.

Those who pass an initial screening are given a PET scan, a noninvasive form of nuclear medicine imaging, of the brain, to see if they have a buildup of beta-amyloid in the brain.

Study subjects have to be emotionally prepared to live with the knowledge that they have beta-amyloid deposits even if they don't have symptoms, said Pomara.

Half the subjects who are chosen for the study will monthly receive the experimental drug and half will get a placebo. Results from earlier trials of solanezumab have been mixed, with some showing modest improvement and some showing no change in disease progression.