Alzheimer’s Patients Take Part in Clinical Trials for New Vaccine

Greg Marion, 47, a general contractor who owns Marion Construction in Jupiter, said his mother, Earline, 81, had been doing fine up until a few years ago. But then he found out that she had been writing checks to a fraudulent sweepstakes charity that was taking advantage of her. Marion took over her finances and moved her into the house next door to him. “She was very disoriented, confused and uncomfortable. I thought that maybe the move was traumatic for her, but, after she settled in, she started repeating herself every few minutes.” Their doctor suggested that she see a neurologist at Premiere Research Institute at Palm Beach Neurology in West Palm Beach.

“At first, she didn’t want to go to another doctor, but then she admitted to me that she was having symptoms consistent with Alzheimer’s.

“So, we went to see Dr. Walter Martinez (the institute’s co-director) and she had some initial review tests and MRIs, and, at that point, she was diagnosed with early onset Alzheimer’s and he explained the disease to us.” Earline was given prescriptions for an Excelon patch (which decreases the chemical, acetylcholine) and Namenda (a drug that regulates the activity of the chemical, glutamate) and she is taking part in a clinical trial with Bapineuzumab (a vaccine that appears to bind to amyloid and neutralize its toxic effects).

“We noticed within a couple of weeks that she stopped repeating herself,” Marion said.

Six years ago, Mickey Rodriguez of Stuart noticed that her husband, Frank, 75, was becoming forgetful. “He’d ask me the same thing over and over, and say, ‘I saw that before,’ when I knew he had not.”

She took her husband to Premiere Research Institute to have him tested, and “they found that he fits into the Alzheimer’s category,” she said.

Although she and her husband knew that there is no cure for the disease, they decided that he would take part in clinical trials. “I thought if I could get him into treatment early, we could stall it, or, who knows, maybe it will help our grandchildren, at least,” Rodriguez said.

All in all, Frank has taken part in four clinical trials at the institute, three with varying dosages of Aricept (a drug that decreases the chemical, acetylcholine) and one in combination with an injection of Bapineuzumab. He did best, Mickey felt, when he was taking 23 milligrams of the Aricept. “He did very well on that dosage. Years ago, he used to paint. He started again and was better at it than ever. He thrived on that drug.”

But, when the trial was over, the FDA put a hold on that drug dosage because of side effects that some of the patients experienced. “So we weren’t given the drug for free, which usually happens for people who take part in the study,” Rodriguez explained.

“But, since then, the FDA has lifted the hold, and I’m hoping that our doctors will arrange for him to get a prescription for 23 milligrams of Aricept because it really helped him,” she said.

Both the Rodriguez family and the Marion family couldn’t be happier with the care they’ve received at the research institute. And while they hope that their taking part in clinical trials will slow down the progression of their disease, they also want to contribute to research that might produce new medicines that can help others in the future.

Dr. Carl Sadowsky, co-director of research at Premiere Research Institute, has been conducting trials for more than 25 years. He is also medical director of the Memory Disorders Center at St. Mary’s Hospital, a clinical associate professor, Division of Neurology, at Nova Southeastern University and a board member of the Southeast Florida Alzheimer’s Association.

“Frank and Earline are on one of the disease-modifying therapies,” Sadowsky said.

“We are using antibodies to try to reduce the amyloid burden in the brain.”

Amyloid, a sticky protein that damages the neurons is the real culprit with Alzheimer’s and the time to treat the elevated amyloid is before it causes damage, he said. “To illustrate, think about cholesterol.

“We don’t wait until a person has a stroke. If a person’s cholesterol reading is high, we put them on drugs because we know that cholesterol will cause damage.

“There are a whole group of treatments to lower amyloid.”

For some trials, an antigen is given to the patients so they can develop their own antibodies and researchers are also working on multiple ways to remove amyloid from the brain using immune therapy, he explained.

Sadowsky said he and his team are able to recruit for trials because they have good ongoing relationships with the people they treat. “We take care of our patients,” he said. “Just this year, a patient I cared for will be involved in a study of General Electrics. He has a life expectancy of less than one year.

“The study requires a brain donation.”

“We will scan his brain now, and compare it to a scan taken post mortem, looking for amyloid.

“This is not an easy thing to talk about with people as you can imagine,” he said. “It’s very hard to advertise for a study like that. It’s easier if you have a good relationship with your patients.”

But these are critical tests, he said. “We need to treat Alzheimer’s patients earlier before the disease becomes severe.

“Alzheimer’s is becoming the epidemic of the 21st century – 5.3 million Americans have Alzheimer’s. If you make it to age 85, your chances of getting it are 40-50 percent.

“The longer you live, the greater the risk. It’s expensive, devastating and if we don’t get a better handle on it, it will overwhelm us financially and medically.”

In the last five years, researchers have made progress in understanding the disease, which was recognized in 1907 by Dr. Alois Alzheimer, he said.

“The Alzheimer’s vaccine by Pfizer/Wyeth, Bapineuzumab, looks promising – an antigen is given so that the patients develops their own antibodies.”

Patients undergoing trials at his institute are counseled about the benefits and risks and they don’t pay for treatment. “They are given a small stipend for their time and to cover some of the gasoline for their travel. That’s important because they are donating their time and effort.

“If the requirements for the trial are too difficult, they won’t participate. We have to be cognitive of what the patient and family wants.”

For help with finding appropriate testing, read about Alheimer’s Association’s ProjectMatch, here.

Written for Palm2Jupiter

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