Promising new therapy for Alzheimers, dementia

It started with a picture on a desk. Larry Sizeler saw it and had to ask who the young woman was.

It was the daughter of one of Sizeler’s clients. Within minutes, the client put Sizeler on the phone with his daughter. After a few minutes, Sizeler had a dinner date for the next week.

On the date, sparks flew.

“I think we both knew that night that we would end up getting married,’’ says the woman who became Janet Sizeler a year later. “It was nirvana.’’

The meeting was in 1971. The wedding was in 1972.

Today, their marriage is as strong as ever. More importantly, Janet is closer to being the woman in the picture and on that first date than she has been in years.

On a recent afternoon, the couple sat at the kitchen table of their Carrollwood home with a reporter. Larry, 76, asked Janet, 77, where they had dinner the night before.

“Cracker Barrel,’’ Janet answered instantly.

This may sound like a minor detail, but it’s hugely significant.

Larry smiles and proudly says, “She wouldn’t have known that before all this.’’
“All this’’ is a clinical study being done by NeuroEM Therapeutics and the Byrd Alzheimer’s Institute at the University of South Florida. It’s been a breakthrough for Janet, who was diagnosed with Alzheimer’s Disease in 2013. Alzheimer’s is a progressive brain disease that causes memory loss, language problems, and other symptoms. It is the sixth-leading cause of death in the United States and it’s estimated that 5.8 million Americans currently are living with the disease. It’s still early in the process, but NeuroEM CEO and former USF professor Dr. Gary Arendash says he’s optimistic the study can be a breakthrough for millions with the disease.

Signs of cognitive improvement

“The results we’ve seen so far have shown cognitive improvement,’’ Arendash says. “Even slowing the progression of the disease would be nice. But I think we’re on a track to not just stabilizing, but actually bringing cognitive improvement. If we’re able to continue going through the process and proving this works, then we’ll be able to help lots of people who have Alzheimer’s. It would be very gratifying to me and a big feather in USF’s cap.’’

It’s ironic that Arendash uses the word “cap’’ because that’s what he calls the device that is at the center of his study. The device is a head cap that is filled with highly-specialized emitters that are activated sequentially to send electromagnetic waves to all
“The results we’ve seen so far have shown cognitive improvement,’’ says Dr. Gary Arendash. “Even slowing the progression of the disease would be nice. But I think we’re on a track to not just stabilizing, but actually bringing cognitive improvement.''
parts of the brain. Technically, the process is called Transcranial Electromagnetic Treatment (TEMT). Participants in the first trial wore the cap for one hour, twice a day for two months. The process is done in-home and the patient can do most normal activities while wearing the device.

“In my opinion, the pharmaceutical industry has not been very effective in slowing or reversing the cognitive impairment of Alzheimer’s disease,’’ says Arendash, who left USF in 2013 and moved to Phoenix, where he started NeuroEM Therapeutics.

“There have been some attempts to do things such as transcranial magnetic stimulation or transcranial direct current stimulation. But this study uses both magnetic and electric waves. This study is the first to administer electromagnet waves to the entire human brain over an extended period of two months. Treating the brain globally is very important because Alzheimer’s impacts the brain on a global basis.’’

The results have been better than expected. Take Janet for example. A former registered nurse, Janet survived a battle with colon cancer in 2001 and lung cancer nine years ago. She underwent chemotherapy for both cancers. When Larry and their friends first noticed her struggling with short-term memory, they thought it was “chemo brain’’, a condition that causes chemo patients to experience mental fogginess. As Janet’s condition worsened, she had trouble remembering what day of the week it was and, although her memory was crystal clear on the distant past, she often couldn’t remember what she did or said 10 minutes earlier.

But Janet isn’t foggy these days and she and Larry say that TEMT is the reason.

As she sat at her kitchen table with her husband and the reporter, Janet was an active participant in the conversation. If she was having any memory issues, they weren’t apparent. In fact, she even stepped in twice to correct Larry on minor factual details.

“She really has gotten much closer to where she used to be,’’ says Larry, who is his wife’s caregiver while working out of home as a stockbroker. “Not only is her memory improving, but so is her attention span and she’s not getting frustrated as much as she did.’’

Larry gets a break on Tuesdays and Thursdays when Janet goes to an adult daycare center and when their daughter Cydney B. Miller, who lives in Nashville, Tenn., makes one of her frequent visits to Tampa. But Larry says his job as caregiver has become easier as Janet’s condition has improved.

A significant clinical trial coming up

While Janet represents the human side of this study, the scientific side is the genesis of it all. The initial study was small, just eight patients. To qualify for the study, a patient had to be over 60 and had to be diagnosed with early or moderate Alzheimer’s disease. The results were spectacular. Seven of the patients showed improvement in their ADAS-cog score, which is the baseline for testing Alzheimer’s therapeutics. It was also determined that none of the patients experienced any safety issues with TEMT.

Arendash says the scientific purpose for TEMT is to disaggregate toxic proteins inside brain cells, specifically A-Beta and tau. That, Arendash says, helps reverse the cognitive damage done by Alzheimer’s. USF has the patent for the device and NeuroEM has exclusive rights to the device. Although the TEMT treatment was done at home, patients in the study had to make regular visits to the Byrd Institute to have their condition monitored.

“These results provide preliminary evidence that TEMT administration we assessed in this small study may have the capacity to enhance cognitive performance in patients with mild to moderate disease,’’ says Amanda Smith, M.D., Director of Clinical Research at the Byrd Institute.

The next step, Arendash says, is a second, and much larger, clinical trial. He hopes to start that in the spring and wants to include 150 patients.

“After the results we had, I don’t think we’ll have much of a problem finding patients this time around,’’ Arendash says. “This next trial is crucial for us. If it goes as well as we hope it does, we’ll get (Food and Drug Administration) approval. If we get that, then we can start helping a lot of other people. Again, stabilizing the disease is fine. But we’re selfish. We don’t want to settle for stabilization. We want improvement.’’

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Read more articles by Patrick Yasinskas.

Patrick “Pat” Yasinskas is an award-winning Tampa-based freelance writer. He has covered the National Football League since 1992 and worked for The Tampa Tribune, The Charlotte Observer and ESPN. He also has served as a selector for the Pro Football Hall of Fame and the NFC South chairman of the Pro Football Writers Association. He also has been an avid baseball card collector since the 1970s.