LIFE WITH ALZHEIMER'S

Healthy people needed for Alzheimer's clinical trials

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Pat and Ron Carmichael recently celebrated with 55th wedding anniversary. (Source: 3TV) Pat and Ron Carmichael recently celebrated with 55th wedding anniversary. (Source: 3TV)
"She went to an afternoon matinee movie with the girls, and we came home that night with Alzheimer's," Ron said. (Source: 3TV) "She went to an afternoon matinee movie with the girls, and we came home that night with Alzheimer's," Ron said. (Source: 3TV)
Pat is part of a clinical trial for Deep Brain Stimulation. Ron believes it has helped. (Source: 3TV) Pat is part of a clinical trial for Deep Brain Stimulation. Ron believes it has helped. (Source: 3TV)
For DBS, an implanted battery transmitter in your chest is wired up your neck with leads running into the frontal lobe --  or superhighway of your brain -- where electrodes zap the plaque that cause Alzheimer's. (Source: 3TV) For DBS, an implanted battery transmitter in your chest is wired up your neck with leads running into the frontal lobe --  or superhighway of your brain -- where electrodes zap the plaque that cause Alzheimer's. (Source: 3TV)
"We actually have the chance of preventing this illness; we have a chance of finding a cure," said Dr. Anna Burke, who ran the trial in which Pat participated. (Source: 3TV) "We actually have the chance of preventing this illness; we have a chance of finding a cure," said Dr. Anna Burke, who ran the trial in which Pat participated. (Source: 3TV)
PHOENIX (3TV/CBS 5) -

It has been a decade since the last new drug to treat Alzheimer's disease came out.

There are quite a few clinical trials underway to find a cure and new therapies, but 80 percent of those trials are delayed because not enough healthy people participate.

Alzheimer's is a debilitating, degenerative disease with no known cure, so it's understandable that many patients are eager to investigate experimental drugs that might improve their quality of life.

Experts say not enough people realize that even if you don't have Alzheimer’s, you can still actively contribute to a cure through clinical trials.

Ron and Pat Carmichael would like to see that happen.

They just celebrated their 55th wedding anniversary, but it's not exactly the golden years they'd envisioned.

SLIDESHOW: Meet the Carmichaels

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"One day, she takes off to go visit with her girlfriends to see a movie at Christown Mall.  She got very confused and a little panic-stricken," Ron explained.

Pat didn't know where she was or what she was doing. 

The police called Ron.

"I wasn't totally alone," Pat said when asked about what happened that day that changed the couple's lives six years ago.

"You were by yourself," her husband interjected.

Telling and re-telling the story over the years gets a little muddy.

"I knew I'd probably be fine if I could find somebody to talk to," Pat said. "So I talked to a person I did not know; she must have seen I was a little frustrated. So she took me up to the mall and we got things settled. I went in and sat down. End of story."

"It was a little different than that," Ron said. "The policeman came and was helping you, too, then he called me. You remember that?"

"No," Pat answered.

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"She went to an afternoon matinee movie with the girls, and we came home that night with Alzheimer's."

"Wow. It's like somebody taking a big ol' cold bucket of water and throwing it in your face!" Ron said.

It wasn't their first health scare. Pat is also a breast cancer survivor.

"I guess I think it's better to find out," Pat said

So they went after Alzheimer's with the same gusto.

"We didn't want it. Nobody wants it," Ron said. "But it gave us at least a direction. We knew what we were dealing with."

They immediately signed on for a couple clinical trials and then a much more invasive experimental procedure.

BLOG: Clinical trials: A difficult decision, the right one for my family

"It required brain surgery," Ron said. "And why would you volunteer to have brain surgery, what are you thinking? That occurred to me at the time, and since."

Dr. Anna Burke ran the Deep Brain Stimulation (DBS) trial Pat participated in at Banner Alzheimer's Institute.

"The reason we have the medications we do at this point -- that can slow the progression of the illness -- is because there were brave souls willing to take the time and participate in these clinical trials," Burke said.

The DBS is almost like a pacemaker for your brain.

An implanted battery transmitter in your chest is wired up your neck with leads running into the frontal lobe --  or superhighway of your brain -- where electrodes zap the plaque that causes Alzheimer's.

"We actually have the chance of preventing this illness; we have a chance of finding a cure," Burke said.

My parents were emboldened by the possibilities to make a difference that the clinical trial offered. ... I see now that by taking part in this clinical trial and others, my mom and dad (her caregiver) have taken the power back. They have become part of the solution. 

DBS has already proved promising in patients with Parkinson's disease.

There was a 50 percent chance Pat's device would never even be turned on, that she would be part of the placebo control group. But there was also the chance to possibly slow the progression of the insidious and minimize the damage.

As it turns out, Pat's implanted device was on from the beginning.

"I think it's improved our quality of life," Ron said.

But that's not why they agreed to go through with it.

"We weren't looking for a cure," Ron explained. "We knew all we were doing is adding to the body of science and what might help others. It was more for our kids and grandkids."

And while he's convinced Pat's now doing better than her peers because of the DBS, the protocol is still five to seven years from FDA approval.

"We need people to become involved, to care enough to make the commitment," Burke said.

She said clinical trials will never get to the next step unless healthy people participate to prove it's safe.

"There has really been no new therapy for the past decade and this is why we need the clinical trials," she explained. "We want people to live their golden years as their golden years, not worry about losing pieces of themselves or being a burden to their loved ones."

Ron and Pat are all in.

Pat also has agreed to donate her brain to science.

Six years into this "new normal" of an uncertain future, Ron said you can't just wait for time to pass and memories to lapse.

He says you should do all you can with the time you have.

"A lot of people say, 'I'm gonna go down fighting, doing everything I can to make sure my family, my children, my grandchildren never have to suffer what I'm going through right now,' And that keeps me motivated," Burke.

We want people to live their golden years as their golden years, not worry about losing pieces of themselves or being a burden to their loved ones.

Other benefits of clinical trials

Burke said all drugs and devices in all clinical trials are run through several rounds of lab and rodent tests to make sure they're not toxic before any human trials. She said they're vetted so researchers are aware of all possible side effects before human trials, which start off with small groups of participants and progress to larger groups. All of those participants are being constantly watched by specialists.

"One of the benefits of being in a clinical trial is having a team of experts hovering around you, several times a month," Burke said, "That's the kind of care you would not receive in the community from your primary care doctor or neurologist. In fact, if you look at people in clinical trials, they're oftentimes healthier."

Doctors are constantly testing everything -- patients' lives, their hearts, their kidneys -- to ensure that every organ is functioning properly.

"If there's a problem, we'll catch it early," Burke said.

Clinical trials take time. Lots of it.

"That whole process lasts about a decade! It's a long time," Burke said. "And every step of the way, we, as in the researchers and drug companies that are actually studying the medications, have to prove that the medications are safe and that they're doing what they are meant to do."

Burke said data safety monitoring boards review the clinical trials several times a year to make sure it's still safe to continue. That's a federal requirement.

"And if you don't meet those criteria, the FDA will not let you move forward, and the medications may not come to market," she said.

Pat was one of 43 people involved in the second clinical trial for the DBS.

We knew all we were doing is adding to the body of science and what might help others. It was more for our kids and grandkids.

Another 200 people are slated to start a third human trial in the next year.

"I think that it's done a lot of good," Ron said. "It's something I hope shows promise for the future."

Click here for information about studies that are currently enrolling participants. You also may call 602-839-6500.

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