GAP-Net site Brigham and Women’s CART was featured with two of their Citizen Scientists in the Boston Business Journal about COVID-related delays and the dedication of AD volunteers.

Joining a clinical trial may not be the first idea that pops into your head when wondering how to make new friends after moving to a new area. But for Alice Bailey, it was the “most incredible gift.”

Bailey, 77, and her husband enrolled in a clinical trial at Brigham and Women’s Hospital’s Center for Alzheimer’s Research and Treatment (CART) after moving from Italy to Cambridge nearly five years ago.

The decision has come with downsides. Throughout the trial, they’ve watched new friends struggle with the memory deteriorating disease. Brain scans have shown that Bailey herself has the sticky amyloid plaque characteristic of Alzheimer’s sufferers. Nevertheless, she’s itching for the pandemic to be over so she can re-start her routine of taking the bus to the hospital for check-ins.

“My husband and I feel that we both have had a blessed life. As a coronary patient, he has outlived his best predictions. We’re both aware of how enriched this chapter is in our lives,” she said. “I would rather be participating and active than be passive and ruminating about the ‘what ifs.'”

But the Covid-19 pandemic has brought a new “what if” into many clinical trials. Above and beyond the money and time that Covid-19 has cost researchers and drug developers, the virus has threatened something much more precious: the people that researchers rely on for clues to treat neurological disease.

Getting the courage

There are close to six million people with Alzheimer’s disease in the U.S. Most of them are 65 years or older – one of the groups that is most likely to develop severe cases of Covid-19 and are generally more vulnerable to the disease, according to experts.

But it’s not just Alzheimer’s patients researchers are concerned about. “People in their mid-80s and 90s are most precious to us because we learn a lot about aging from them,” CART co-director Dorene Rentz said.

Not everyone in CART’s clinical trials has approached it with Bailey’s gung-ho attitude. Westford resident Dennis Chan, 68, and his wife debated how much of a peek into their futures they wanted, even after Chan’s wife went through a health scare that doctors thought may have been Alzheimer’s-related.

A retired computer scientist, the prospect of his memory and ability to function deteriorating scared Chan. Joining a clinical trial wouldn’t change his chances of developing Alzheimer’s, but it could mean facing a diagnosis sooner.

That potential outcome is the first thing Bailey’s children and other relatives would ask when she announced she was joining a clinical trial.

“It took us a few years to get enough courage,” Chan admitted.

His mindset has changed over the years, though. Chan now looks at the disease as something that could not only affect himself and his wife, but their children, too.

Bailey and Chan also worry the novel coronavirus could put a damper on the momentum thats built up around Alzheimer’s disease research over the last several years.

‘Mixing apples and oranges’

Bailey, Chan and other clinical trial participants have invested years of their lives into this research. Before Covid-19 forced a halt on in-person clinic visits in March, Chan had been receiving infusions of Eli Lilly & Co.’s (NYSE: LLY) experimental drug solanezumab every month for two years (Bailey is involved in the same trial).

Trials of that size not only necessitate a large investment of time, but also of cash, according to Kent Leslie, the chief scientific officer at local neurological disease startup Amylyx Inc. And that cash is hard to come by, as the failure rate for Alzheimer’s drug trials often “terrifies” investors, Amylyx CEO Josh Cohen told the Business Journal.

Rentz estimates that 19 high-profile trials have flamed out in recent years. Most large drugmakers have now abandoned the field.

Amylyx recently raised a $30 million Series B round, but is also listed in a federal database as receiving a Paycheck Protection Program loan to keep the business running during the pandemic.

The startup has been running smaller trials of its potential treatment with between 100 and 140 subjects, as opposed to the few thousand that will be studied in its Phase 3 trial. Executives hope that by collecting enough positive data, they can convince investors the risk is relatively low before heading into the next phase.

Over the last several months, the startup has had to tweak its tactics, ringing up additional expenses.

Instead of having subjects get their blood drawn at a hospital, the startup has paid home health workers or phlebotomists to make house calls. Some assessments of cognitive functions can be conducted over Zoom, while others using MRI scans or spinal fluid cannot.

CART has also turned to digital tools to keep the testing momentum going. But researchers don’t really know how the data collected over an iPad compares to the gold standard of in-person assessments. “We’re mixing apples and oranges,” Rentz said.

Whatever curveballs Covid-19 has thrown at them, researchers agree they owe it to the patients to push through – particularly for the trial participants that have been by their side for years.

“We’re talking about a generation that’s been through a lot: war, depressions, riots,” Rentz noted. “They have a lot of resilience. The people that volunteer for clinical trials are probably the most resilient folks I know.”

Originally posted by the Boston Business Journal on July 14, 2020.