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Alzheimer’s study seeks participants, aims to slow progression of disease

Canton Repository - 1/7/2022

Dr. Shishuka Malhotra has conducted hundreds of clinical research trials in her two decades of experience, but some hit closer to home than others.

The psychiatrist is doing treatment research regarding Alzheimer's disease, the very illness that pushed her toward a career in psychiatry and research in the first place.

Her grandmother, an Indian independence activist in her youth, began struggling with Alzheimer's while Malhotra was in medical school.

"I saw her become childlike and regress," she said. "It can have a devastating effect on the family."

Her clinic, Neuro-Behavioral Clinical Research, is currently enrolling subjects in a clinical trial of an Alzheimer's treatment that hopes to slow the progression of the disease.

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"The goal with these treatments is that if we address this issue early enough, we can stop the disease progression," said Malhotra, who leads the clinic. "It means that if you started having memory problems, then we can just keep it there where patient doesn't get worse or we can revert it back to towards more of a normal state where the patient was before."

The clinic is one of 45 U.S. sites participating in the study, called LIFT-AD. They're investigating Athira Pharma's drug ATH-1017, which the company and researchers theorize could slow or even halt Alzheimer's related degeneration by preventing cell death and promoting growth in brain pathways that affect cognition.

Malhotra's clinic in Green has been conducting research for more than 15 years. She says she has earned trust from the community over the years, taking care of many patients for free and connecting others to care resources.

Individuals between the ages of 55 and 85 who have been diagnosed with Alzheimer's disease may be eligible to participate in the study. Malhotra's clinic offers compensation to participants and transportation if needed, and more details are available on their website at nbclinicalresearch.com/.

In Ohio, 220,000 people over the age of 65 are currently living with Alzheimer's. Those numbers are projected to grow, according to the Alzheimer's Association, particularly as people live longer and as heart disease and diabetes, both of which are risk factors for Alzheimer's development, also rise.

Edwina Blackwell Clark, senior director of communications for the Alzheimer's Association in Ohio, emphasized that the disease is not normal aging or memory loss, and is a major cause of death for older adults.

"Nationwide, one in three seniors dies from Alzheimer's or dementia, and Ohio is an aging state," Blackwell Clark said. "Alzheimer's kills more than brain cancer and prostate cancer combined."

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The Alzheimer's Association's mission is to support research and individuals and loved ones dealing with Alzheimer's. Blackwell Clark says that the Greater East Ohio chapter, which is based in Canton, runs multiple support groups for caregivers, referrals for doctors or clinical trials to participate in and a 24/7 hotline for resource connection.

Clinical trials, she said, are an important part of their care coordination work as it helps the patients who participate and helps deepen the field's research.

"It is a personal decision, clearly, but there is great benefit to participating in clinical trials," she said.

Akron resident Eric Steckel, 78, is one of the three current participants in the trial.

He's always been medically inclined, and has held numerous jobs over the years: managing an office and comforting patients at an HIV clinic in the '80s, working as a surgical tech on and off for two decades and numerous other odd jobs and community roles.

"I understand the importance of research," Steckel said. "I've had a number of family members and other relatives and friends who have dementia, and so I said, 'OK,' if there's anything I can do to help further this along. I also worked in a memory care community in Florida a couple of times and saw how important it is for family and friends to be involved and find some way to cure this or at least slow it down."

He said he barely made the cutoff for the study, which is only enrolling subjects with mild to moderate signs of Alzheimer's, and was glad to be able to contribute to the research.

"In 20 years, I'd be 98 years old. I said, 'Am I going to be aware that I'm 98 years old?' That would be the concern, looking at a mirror and not knowing who you are," Steckel said.

After the initial screening, he said, which involves memory assessments and blood work, participants begin receiving one of two randomly chosen doses of the ATH-1017 or a placebo. Throughout the study duration, the participant or their study partner — in Steckel's case, his sister-in-law — will administer a daily injection. Over the course of six months, participants will regularly check in in-person and over the phone with the clinic for memory assessments and more blood work.

While Steckel is enthusiastic about participating, according to a white paper from the University of Southern California Schaeffer Centerfor Health Policy and Economics, the vast majority of potential participants are never referred to clinical trials.

Low participation in trials is driven by a number of barriers, including lack of knowledge of studies, restrictive eligibility criteria, significant timelines for participation. Malhotra said there's some fear around being involved in a clinical trial, even when the medications have been deemed safe, from people who don't want to be 'guinea pigs.' Part of the purpose of clinical trials is to assess the safety and efficacy of the investigational drugs, which undergo preclinical studies to answer basic questions of safety before they move to human trials.

"We try to educate the community that, actually, you get a very caring and very intense relationship with the doctors and nurses when you work in research trials because we spend a lot of time with the patient and in outpatient, we have addressed already that these drugs have been shown to be safe to be used in human beings, so they are not guinea pigs," Malhotra said.

Both Malhotra and Blackwell Clark said that clinical trials tend to lead to better patient health outcomes, due at least in part to the level of personal care participants receive. Malhotra said other parts of Alzheimer's research itself, which includes testing cognition with various activities, may even help participants keep practicing those cognitive skills.

One thing that the researchers hope to do as they seek out more participants is increase the diversity of those involved in the clinical trials. Blackwell Clark said that in her organization's research, they found that older Black and Hispanic people are disproportionately more likely to have Alzheimer's, while also being more likely to have missed diagnoses.

"We need more people in clinical trials, and we need diversity," Blackwell Clark said. "We need more people of color to participate in clinical trials, so that when there are new drugs or new treatments, that it is applicable and we understand how it works for everyone."

Sam Zern can be reached at szern@cantonrep.com or 330-580-8322. You can also find her on Twitter at @sam_zern.

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