The Tangled Neuron

The Alzheimer's Research Registry

Summary: Alzheimer’s researchers say it’s difficult to recruit participants for clinical trials. Whether or not you have memory problems, joining the Alzheimer’s Research Registry is one way you can help move research forward.

In a post about Alzheimer’s research at Sun Health Research Institute, I wrote about the difficulties researchers face in recruiting participants for clinical trials. This can delay a study by months or even years.

To address this problem, the Arizona Alzheimer’s Consortium, a group of Arizona research institutions, has set up a clinical trial registry to recruit and screen participants for current and future studies. The Alzheimer’s Research Registry was launched in March of this year to screen people with and without memory problems for studies and trials including:

- treatment studies for people with probable Alzheimer’s
- non-treatment studies for people with Alzheimer’s
- treatment studies for people with mild cognitive impairment
- planned (but not yet available) prevention studies for cognitively normal people
- non-treatment studies for cognitively normal people.

Why Screen Potential Participants Before A Study Starts?

“People sometimes ask why the Arizona Alzheimer’s Consortium is evaluating potential study participants for studies that may not exist yet,” says Dr. Pierre Tariot, Associate Director of the Banner Alzheimer’s Institute. He and Dr. Marwan Sabbagh of Sun Health Research Institute co-founded the registry. “The reason is that the field anticipates a wave of both treatment and prevention studies in the coming months and years. There are likely to be literally hundreds of studies. From prior experience with a large prevention trial, as well as treatment studies, Dr. Sabbagh and I learned that waiting until a study is completely ready to start can result in considerable lost time. We and our Arizona Alzheimer’s Consortium colleagues chose to anticipate this surfeit of trials, so that as soon as they become available we can immediately refer significant numbers of prospective participants. We want to be able to turn the key and go, without losing precious months.”

Pierre Tariot, M.D.

People in the registry are already participating in trials. “About 150 have been referred to current studies,” Dr. Tariot says, “not all of which are clinical trials. These include biomarkers studies, imaging studies, and several treatment studies for people with probable Alzheimer’s. The last category has included the ADCS DHA trial, two rosiglitazone trials, a cognitive enhancer trial, and an immunotherapy trial.” Since the registry’s launch, approximately 1100 people have contacted the registry. About 500 have been screened, and another 50 await screening.

Joining the Registry

You must be over 50 to be in the registry. Joining is free, and can be done by mail and telephone [call 602-239-6500 or email registryinfo@azalz.org to get the necessary forms]. After the initial screening, depending on the study involved, further medical evaluation may be needed to clarify your cognitive status or diagnosis.

People who live outside Arizona can join the registry, says Dr. Tariot, but they must be able to travel to the state. “Frequency of travel depends greatly upon the particular study,” he says, “ranging from as little as a one or two day visit for the simplest non-treatment study to roughly twice a month in the most intensive studies. Studies involving treatment often average about one visit every month or two. Also bear in mind that studies with higher potential for risk, such as immunotherapy, might not be a good choice for someone living at a great distance.”

If you want to see Alzheimer’s research move forward, joining the Alzheimer’s Research Registry is one way to help.

The Gap

I just came home from the grand opening of the Byrd Alzheimer’s Research Center and Research Institute here in Tampa. I’m excited to have great research going on in my back yard, and I’ll write more about it soon.

Then I turned on my computer to check on Had a Dad, Bert Piedmont’s blog about her dad’s dementia. Her father was taken to the hospital last weekend after he became violent. Bert says he is drugged, restrained and not getting the care and meds he needs. For a variety of (silly) reasons, she and her family have been unable to get him into the appropriate care facility.

There’s still a big gap between the promise of new research for the coming years and the reality of dealing with dementia minute by minute. I remember how much this gap frustrated me when my father was alive, and I know Bert must be sick about it.

With the state of Florida in budget-cutting mode, the Byrd Alzheimer's Center and Research Institute faces major funding cuts. This problem isn't isolated to Florida - funding for Alzheimer's research is scarce worldwide. Doesn't look like we'll close the research-reality gap anytime soon.

Participating in Alzheimer's Clinical Trials in Sun City, Arizona

Summary: A trial volunteer and a doctor talk about how the close relationship between the community of Sun City, Arizona and Alzheimer’s researchers at Sun Health Research Institute benefits everyone. For Alzheimer’s research to move forward quickly, more people with and without memory problems need to participate in clinical trials.

Ruthann Welander flew from Arizona to New England last month to take part in a cultural exchange program. When she got off the plane, her leg started to hurt. When the pain got worse, her host drove her to the emergency room. All signs pointed to a life-threatening blood clot, but she wasn’t worried about dying. She was worried about donating her brain.

“I’m in a research study and if something goes haywire here – everybody’s gotta go sometime, what’s the difference - I just want you to take this little stamp on my driver’s license and call that number,” she told the woman she was staying with. “That’s Dr. Sabbagh at the research center in Sun City, Arizona and he will tell you where to take my brain.”

Fortunately, Ruthann didn’t have a blood clot. But she does have a family history of dementia. She watched her father, a professor, sink into confusion before his death. And although Ruthann does not have memory problems, her two older sisters had dementia before they died. So when Dr. Marwan Sabbagh, Director of Clinical Research at the Cleo Roberts Center of Clinical Research (part of the Sun Health Research Institute) came to talk to her Kiwanis club a few years back, she paid close attention.

Marwan Sabbagh, MD

“At the end of his talk, he urged any of us who had family members with Alzheimer’s to come and see him at his office,” Ruthann remembers, “because he was just getting started on the ADAPT study [Alzheimer’s Disease Anti-Inflammatory Prevention Trial]. I beat him back to his office, and I’ve been working with him ever since.”

“She’s the poster person for who we want to see as a trial participant,” says Dr. Sabbagh. “Ruthann’s in lots of programs, including ADAPT and our brain and body program. She’s an enthusiastic supporter of the research institute.” Besides participating in several clinical trials, Ruthann arranges for Dr. Sabbagh to speak at meetings of the many community organizations she belongs to.

His talks cover the wide range of Alzheimer’s research going on at Sun Health, from basic science to clinical trials. “Our portfolio is very rich,” says Dr. Sabbagh. “It includes studies involving diabetic medications, gamma secretase modulating drugs, active immunization, passive immunization, secretase inhibitors and gamma globulin therapy. We are doing no fewer than six separate biomarker studies, and we were the first ones to propose statins to treat Alzheimer’s.”

Trials like these don’t happen without volunteers, both with memory problems and without. But it’s not so easy recruiting these volunteers. “It takes years and years to get these drugs to market,” Dr. Sabbagh says, “and part of the reason is that it’s really challenging enrolling participants. You will see some studies take six months to recruit, some take two to three years. You know, if you want things to move quickly, it involves people willing to participate.”

Encouraging Participation in Alzheimer’s Research

What would make persons with dementia and their families more likely to participate in research? “I think they need to see that it’s not futile,” says Dr. Sabbagh. “They need to know that there are limitations in the treatments that are currently available and the only way you’re going to get past the limitations is to consider the possibility of participating in clinical trials - not necessarily for posterity, but because it has the potential to help the people who are involved.”

“I’ll give you a great example of that,” he says, “although it’s somewhat controversial. You know about the AN-1792 study – you heard that they had 19 cases of encephalitis, no doubt. [The trial of this vaccine was halted due to this serious problem.] But what you didn’t hear about is the long term follow-up data - it got buried in obscurity. These drugs can work.” In a follow-up of 30 trial participants, researchers found “significantly slower rates of decline of cognitive functions and activities of daily living” in twenty patients who responded to the vaccine. Researchers are now assessing as many trial participants as possible. Five years after the study began, preliminary data seemed to show the vaccine helped some in this larger group, although no final analysis has been published yet.

Of course, taking part in a trial doesn’t guarantee a benefit - trial drugs are not always effective, and do involve risks. Some participants receive placebos. But, argues Dr. Sabbagh, “the bottom line is that every drug you and I take, every pill we put in our bodies, was at one point experimental. People have to understand that when I offer them an opportunity to participate in a clinical trial, I’m trying to add value. The current tools we have are limited, but we can do something more than wait for the eventuality. So it adds hope.”

It seems that Dr. Sabbagh and his colleagues have been successful making this case to residents of Sun City and the surrounding communities. He says more than a thousand people have donated tissue for research through the Institute’s brain and body donation program, and another thousand, including Ruthann Welander, have signed up to donate tissue at death. Recently, the Arizona Alzheimer’s Consortium, a group of institutions including Sun Health, set up a clinical trial registry to recruit and screen participants before they’re needed for trials. According to Dr. Sabbagh, he and his colleagues have screened several hundred people for this registry.

Why is there so much support for Sun Health and for Alzheimer’s research in Sun City? Maybe because volunteers feel that the researchers truly have their best interests in mind. “We’re really committed to the bench to bedside approach,” says Dr. Sabbagh. Through the center he directs, patients receive treatment and care based on the latest research. This gives people like Ruthann some comfort about taking part in trials. She was hesitant to stop taking ginkgo biloba, a requirement of one trial she enrolled in. But, she says, Dr. Sabbagh’s staff told her that if she showed any signs of Alzheimer’s, she would immediately be taken off the study and be given whatever treatment they thought would be most helpful. “So, I thought, what have I got to lose?” she says. “And when they ask me to take other studies, I say if he recommended it, sure, the answer is yes.”

Dr. Sabbagh’s research and the lives of Sun City residents seem intertwined. “We are begotten by our community,” he says. “Our institution is built by gifts from Sun City, and so I get to know them, they get to know me, I get to be part of their lives, they get to be part of my life. These are our brain donors, financial donors, clinical trial participants and private practice patients, so we get to know them. When somebody passes on, I get sad, but I’m perpetually full of hope. I tell everybody my goal in life is to work myself out of a job. I’m more determined than ever, and what better place to do it than Sun City, Arizona?”