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Banner looks to recruit participants for new Alzheimer's study

Posted 4/3/18

By Cecilia Chan

Independent Newsmedia

Seven years from now, Arizona is expected to see a 43 percent increase in the number of people with Alzheimer’s disease if no new medical advances are …

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Banner looks to recruit participants for new Alzheimer's study

Posted

By Cecilia Chan

Independent Newsmedia

Seven years from now, Arizona is expected to see a 43 percent increase in the number of people with Alzheimer’s disease if no new medical advances are made, according to the Alzheimer’s Association.

The irreversible disease is the sixth leading cause of death in the United States and one in three seniors dies from it or another dementia, the Association reported.

In an attempt to slow or prevent the ravages of the memory-robbing disease, Banner Sun Health Research Institute in Sun City is seeking participants for the Generation Program.

“This is such an important study, it’s revolutionary for its time,” said Dr. Edward Zamrini, the Institute’s principal investigator. “Basically this is a study for where we are hoping to be able to delay Alzheimer’s disease.”

Dr. Edward Zamrini

The goal is to recruit eight people for the study who have no symptoms of the disease, but whose genetic makeup and age puts them at a particularly high risk for developing Alzheimer’s.

The hope is that by administering the investigational study medications before people become symptomatic, there will be a better chance of delaying or preventing the onset of the disease.

Researchers want individuals who are between the ages of 60 and 75 and who have the homozygous APOE4 genotype and elevated amyloid A4 protein. A cheek swab will help determine if a person is eligible to participate in the program. Counseling also is included in the screening process.

Criteria that will exclude a person from participating include having a disability that may prevent the participants from completing all study requirements, having a positive drug screen and having a history of malignancy of any organ system, treated or untreated, within the past 60 months.

The Generation Program is made up of two clinical trials: Generation Study 1 and Generation Study 2. Each trial will last for five to eight years and will investigate treatment that may be able to prevent the onset of Alzheimer’s.

One group will take a daily pill and the other will receive a monthly infusion, Dr. Zamrini said. Placebos also will be used in both groups. The drugs could help delay the symptoms of Alzheimer’s but will they stop the disease, is unknown.

With that said, Dr. Zamrini added, “It may stop it in a person’s lifetime.”

For example, say someone is 74 years old now and will die of old age at 86 but he or she is programmed to get Alzheimer’s at age 80, he said.

If either one of the drugs works and delays symptoms for five years, that person would only experience Alzheimer’s for one year, “so effectively it’s preventing Alzheimer’s,” he added.

“But you can’t make that claim because we don’t want to mislead people in saying it prevents Alzheimer’s. All we can do is hope that one or both of these drugs will delay Alzheimer’s. If we can delay Alzheimer’s long enough then a person may never experience Alzheimer’s in their natural lifetime.”

If the two drugs prove to help delay symptoms, the next step is to seek FDA approval, which the doctor said would likely be fast-tracked, taking months rather than a year or longer to get to the public because of the strong need to gain a foothold against Alzheimer’s.

According to the Alzheimer’s Association, an estimated 5.7 million Americans of all ages are living with Alzheimer’s in 2018. This number includes an estimated 5.5 million people age 65 and older and approximately 200,000 individuals under age 65 who have younger-onset Alzheimer’s.

Additionally, one in 10 people age 65 and older or 10 percent has Alzheimer’s dementia and almost two-thirds of Americans with Alzheimer’s are women.

Today, someone in the United States develops Alzheimer’s every 65 seconds and by mid-century, someone in the United States will develop the disease every 33 seconds, according to the Association.

In the meantime, those with the risk gene could help themselves with lifestyle habits.

Although there is no solid evidence, there is neurological evidence that lifestyle measures do help delay the onset of Alzheimer’s, Dr. Zamrini said. That includes eating more fruits and vegetables and less animal fat, exercising daily for half an hour, staying mentally active by reading, doing puzzles or attending lectures, staying socially engaged, minimizing stress, monitoring blood pressure, cholesterol and blood sugar and getting restful sleep, he said.

“All of those things seem to help delay (the disease) by five and 10 years already,” he said. “We want people to live a healthy lifestyle but that by itself is not enough. We still have to find other strategies like medication to help beat Alzheimer’s.”

Banner is one of 190 selected sites around the work trying to recruit more than 3,000 people for the Generation Program.

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