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By Daniel Dunaief

The Food and Drug Administration last week approved donanemab, or Kisunla, an intravenous treatment for early stage Alzheimer’s disease, adding a second medication for mild stages of a disease that robs people of memory and cognitive function.

Nikhil Palekar, Medical Director of the Stony Brook Center of Excellence for Alzheimer’s Disease and Director of the Stony Brook Alzheimer’s Disease Clinical Trials Program. Photo courtesy Stony Brook Medicine/Jeanne Neville

The monoclonal antibody drug from Eli Lilly joins Leqembi from drug makers Eisai and Biogen as ways to reduce the characteristic amyloid plaques that are often used to diagnose Alzheimer’s.

While the medications offer ways to slow but do not stop or reverse Alzheimer’s and come with potential significant side effects, doctors welcomed the treatment options for patients who are at risk of cognitive decline.

Dr. Nikhil Palekar, Medical Director of the Stony Brook Center of Excellence for Alzheimer’s Disease and Director of the Stony Brook Alzheimer’s Disease Clinical Trials Program, has been in the field for about two decades.

“Only in the last three years have I finally become quite optimistic” about new treatments, said Palekar, who is a consultant for Eisai. “We’ve had so many failures in the last few decades” with the current medications targeting the core pathologies.

That optimism comes at a time when more people in the United States and around the world are likely to deal with diseases that affect the elderly, as the number of people in the United States who are 85 and older is expected to double in the next 10 years.

The rates of Alzheimer’s and other forms of dementia is about 13 percent for people between 75 and 84 and is 33 percent for people over 85 according to the Alzheimer’s Association.

The Alzheimer’s Association issued a statement welcoming the addition of Kisunla to the medical arsenal.

“This is real progress,” Joanne Pike, Alzheimer’s Association president and CEO, said in a statement. The approval “allows people more options and greater opportunity to have more time.”

To be sure, Leqembi, which was approved in June of 2023 and Kisunla aren’t a guarantee for improvement and come with some potentially significant side effects.

Some patients had a risk of developing so-called amyloid-related imaging abnormalities, which includes brain edema, or ARIA-E or hemorrhaging, or ARIA-H in the brain.

ARIA can resolve on its own, but can, in rare cases, become severe and life-threatening.

Patients taking these medications receive regular monitoring, including MRI’s before various additional treatments.

Patients are “monitored carefully” before infusions to “go over symptom checklists to make sure they don’t have neurological symptoms,” said Palekar. “If they have any symptoms, the next step is to head to the closest emergency room to get an MRI of the brain, which is the only way to know if a side effect is causing symptoms.”

Nonetheless, under medical supervision, patients who took the medication as a part of clinical trials showed a progressive reduction in amyloid plaques up to 84 percent at 18 months compared to their baseline.

The benefits for Leqembi, which is given every two weeks, and Kisunla, which is administered every four weeks, were similar in terms of slowing the effect of cognitive decline, said Dr. Marc Gordon, Chief of Neurology at Zucker Hillside Hospital in Glen Oaks.

“Neither of them is a cure for Alzheimer’s,” said Gordon. “These medications are not a home run, but at least we’re on base.”

Not eligible

Not everyone is eligible to take these monoclonal antibody treatments.

These drugs are not available for people who have progressed beyond the mild stage of the disease. Clinicians advised those who are showing potential signs of Alzheimer’s to visit their doctors before the disease progresses beyond the point where these drugs might help.

Additionally, people on blood thinners, such as Eliquis, Coumadin, and Warfarin, can not take these drugs because a micro bleed could become a larger hemorrhage.

People who have an active malignant cancer also can’t take these drugs, nor can anyone who has had a reaction to these treatments in the past. The people who might likely know of an allergic reaction to these drugs are those who participated in clinical trials.

Doctors monitor their patients carefully when they administer new drugs and have epinephrine on hand in case of an allergic reaction.

Patients with two alleles – meaning from both parents – of a variant called APOE ε4 have a higher incidence of ARIA, including symptomatic, serious and severe AIRA, compared to those with one allele or non-carriers. 

If patients have this variant on both alleles, which occurs in about 15 percent of Alzheimer’s patients, Gordon and Palekar both counsel patients not to take the drug.

“We don’t think the risk is acceptable” for this patient population, Gordon said.

Ultimately, Palekar believes patients, their doctors and their families need to make informed calculations about the risks and benefits of any treatment, including for Alzheimer’s.

Beyond drugs

Palekar added that recent studies have also shown that an increase in physical exercise and activity, such as aerobic activity three times a week for 45 minutes each time, can “significantly help in patients with cognitive symptoms of Alzheimer’s Disease,” he said.

After consulting with a physician to ensure that such activity is safe, patients can use a stationary bike or take walks which can benefit their bodies and their brains.

Additionally, various diets, such as the mind diet that combines the mediterranean diet and the DASH diet, which emphasize eating green leafy vegetables and berries among other things, can benefit the brain as well.

Patients also improve their cognitive health by continuing mental activity through games as well as by retaining social connections to friends, family and members of the community.

Like many other people, Palekar witnessed the ravages of Alzheimer’s first hand. As a teenager, he saw his aunt, who was smart, caring and loving, stare out the window without being able to communicate and engage in conversation as she battled the disease.

As a condition involving amyloid plaques, tau proteins, and inflammation, Alzheimer’s disease may require a combination of treatments that address the range of causes.

“There’s going to be a combined therapy,” said Gordon. “Just like when we’re treating cancer, we don’t have just one drug. It’s going to be important to figure out the sequencing and whether drugs are given sequentially or cumulatively. It has to be a multi-faceted approach.”

Conceptual drawing of the proposed new marina at Nissequogue River State Park. Image from NYS DEC

New York State officials have revealed a $40 million proposal for the next phase of Nissequogue River State Park development.

The state Department of Environmental Conservation, in partnership with the state Office of Parks, Recreation and Historic Preservation, held two public presentations Nov. 2 at the Kings Park Fire Department for Phase 3 of rehabilitation and restoration of  Nissequogue River State Park, built on the former grounds of the Kings Park Psychiatric Center. Wayne Horsley, regional director for the state office of parks, said that with Phase 3 residents will start to see a substantial improvement in the park.

“This is a community effort; Nissequogue River State Park is worth the effort,” he said. “The park is going to come to life. This will be a positive thing for everybody concerned.”

A state official and resident discuss plans for Phase 3 of the Nissequogue River State Park rehabilitation revealed Nov. 2. Photo by Sara-Megan Walsh

At the center of the preliminary plan is the construction of a new 25,000 square-foot headquarters for the DEC’s Division of Marine Resources in the existing footprint of Building 40, the former child care center, which would be demolished. The move would bring more than 100 DEC employees in the marine fisheries, marine habitat, shellfisheries and oceans program bureaus to Kings Park. It would also house the DEC’s Marine Enforcement unit and bring year-round law enforcement into the park.

“This is a much more ideal place for us,” said James Gilmore, director of the DEC’s Marine Resources Division. “Having a marine program next to the water makes so much more sense than where we are right now, in a medical park that’s six miles from the water.”

The $26 million building would also be equipped with the state’s only FDA-certified shellfish laboratory, for testing and maintaining the health and safety of harvested shellfish, in addition to a marine permit office. Construction of the new facility is expected to begin in the winter of 2018 with a targeted completion date of winter of 2020.

The DEC would also partner with the state parks’ office to design and construct a brand new marina. With a proposed $8 million budget, a new Nissequogue State Park Marina would be built to the south of the existing marina with a 151-boat capacity, new year-round floating docks, boat pump-out facility,  comfort station including restrooms and improved parking area for boaters.

“The advantages I think are pretty clear,” said Craig Green, with the consulting firm D&B Engineers and Architects that has been hired to oversee engineering and design of Phase 3. “It would provide new facilities. It has capacity for existing boats plus DEC’s boats, greater security, better lighting and better access to the boats.”

The parks’ existing north and south marinas would be largely demolished and restoration efforts would be made to return them to wetlands. The existing boat ramp may be retrofitted to be used as a launch for nonmotorized boats, kayaks and paddle boards, according to Horsley. Construction of the new marina would be tentatively slated to begin in 2019.

“The park is going to come to life.”

— Wayne Horsley

The proposed Phase 3 sets aside $1.5 million to bring new water mains and fire hydrants to the park. The announcement was answered with loud applause by approximately 85 attendees at the Nov. 2 meeting.

“If we ever had a fire, [the firefighters] would have adequate water supply to put out the fire,” Horsley said. “It will bring potable water to the DEC building, the administrative building and the park.”

The parks regional director called it a “win-win” as he said new lines would be water to the soccer fields frequently used by local teams.

Other improvements under the proposed Phase 3 include demolition of three fire-damaged buildings and several upgrades to the park’s administrative headquarters including a new roof, window restoration, new heating and cooling systems and improved handicapped access to the building in compliance with the Americans with Disabilities Act.

Detailed conceptual renderings of the proposed DEC building can be found on the agency’s website at www.dec.ny.gov/about/796.html.

Individuals who were unable to attend the two public meetings can comment on the plan until Nov. 30. Feedback may be submitted via email to [email protected] or via mail to: Stephanie Rekemeyer, NYSDEC, 205 Belle Mead Road, Suite 1, East Setauket, New York 11733.

Putting one foot in front of the other never looked so inspiring.

A freak sledding accident in Vermont in 2009 left Greg Durso, 31, of Stony Brook unable to use his lower body from his stomach muscles down. With the help of St. Charles Hospital’s rehabilitation center, he stood and walked across a room Dec. 13 in front of his family and dozens of hospital personnel for the first time since his accident.

Greg Durso, who is paraplegic, walks at St. Charles Hospital Dec. 13 with help from an Indego exoskeleton. Photo by Alex Petroski
Greg Durso, who is paraplegic, walks at St. Charles Hospital Dec. 13 with help from an Indego exoskeleton. Photo by Alex Petroski

Durso was aided by a clinical trial product called the Indego exoskeleton, which is a wearable robotic frame. St. Charles is one of nine hospitals in the United States conducting the clinical trial, and the only one on Long Island. Durso is the first patient at the hospital to take the technology for a spin.

“It’s just an incredible feeling to be up there and be walking again — putting weight on your legs,” Durso said after his groundbreaking stroll. “Each step is kind of like a leap of faith … a month ago I probably couldn’t have told you I’d be here today, so when I heard about this, I was so happy to have the opportunity to do this.”

Indego is the second FDA-approved exoskeleton device used for lower limbs. The device weighs about 26 pounds, and requires no backpack or external wires, as other similar devices have in the past. Currently the machine is operated by Durso’s chest muscles, but future incarnations of the device will allow electrical stimulation in the muscles so that a patient’s own legs will make the machine work, according to St. Charles Physical Medicine and Rehabilitation Medical Director Jennifer Semel. The FDA gave the machine clearance in March.

“The future is really limitless,” Semel said in an interview. “It’s really exciting to see people who haven’t been able to stand up in several years not only to be at the same height as their peers, but to be able to walk. It’s really uplifting.”

Semel said Durso has been using the device for about a month, and last week required a walker in addition to the exoskeleton to get around. He progressed to crutches for his Dec. 13 walk. Semel said the plan is for Durso to continue using the device for several months to gain a better understanding of the health benefits and the impact it has on a patient’s gait.

“I think I was a little skeptical because you realize people always tell you there’s going to be advances, there’s going to be this and that in the future,” Durso said. “But when you see this — I actually get up, I actually walk, I gave my sister a hug for the first time in eight years face to face — it’s pretty emotional and empowering, and it’s just exciting to see where the future is going to go with this technology.”

It was an emotional day for the members of the Durso family in attendance. Durso’s older sister, Jessica Giovan, fought back tears trying to describe seeing her brother walk again for the first time in eight years.

‘It’s just an incredible feeling to be up there and be walking again — putting weight on your legs … each step is kind of like a leap of faith.’

— Greg Durso

“I just saw him look so proud and happy,” she said. “He works so hard at everything he does, so to see him put one foot in front of the other, literally, was just unbelievable … the person you see now is the person he has always been. He has not, for one second, wavered in his personality since the accident. In fact, he has only increased his perseverance and his humor, and he lives everyday to make everyone around him feel like it’s okay.”

His dad, Richard Durso, said he couldn’t have imagined he’d be sitting where he was, watching his son walk, when he heard the news of the accident eight years ago. He credited his son’s positive attitude for keeping him on track. His mom, Jean Durso, called what she saw “unbelievable.”

Durso has competed in Iron Man races and marathons in his life — the former both pre and post accident — and said he hopes to be able to regain some of that lifestyle in the future.

“I love to do athletic things. I mean, it could be anything. I just want to be out there, have fun and live my life the way I want to do it,” he said. “For me that’s enough.”

The Indego devices cost about $80,000 each.