July 16, 2015 - 1:09 pm
A new approach to Alzheimer‘s disease is taking place at the Cleveland Clinic Lou Ruvo Center for Brain Health. Since the first of the year, it‘s been recruiting participants for a new clinical trial, the Anti-Amyloid Treatment in Asymptomatic Alzheimer‘s study, or A4. The study investigates whether treating older individuals with an investigational drug, dubbed solanezumab, can delay memory decline in those who may be at risk to develop Alzheimer‘s disease.
Charles Bernick, M.D., associate medical director, heads the clinical trial at the center, 888 W. Bonneville Ave. He is looking for 15 to 20 people to enroll. They must be age 65 to 85. So far, he has four who are eligible to participate.
"Probably the major barrier and one of the reason studies are not completed is the time it takes to enroll people," he said. "A lot of the people you screen are not going to be eligible. So, the sooner we get participants, the sooner we get the answers."
Recruitment will remain open about another six months or until the study meets its quota.
The A4 study also aims to learn more about brain markers and other tests to better predict who will experience memory decline and progress toward Alzheimer’s-related dementia. The study includes undergoing a positron emission tomography (PET) scan, which produces a 3-D image of functional processes in the body.
Sen. Sandra Tiffany, 66, volunteered for the study. She has a family history of Alzheimer‘s – her father has it, and her late grandmother had it. Tiffany said she wanted to be proactive and take responsibility for her health.
"At my age, you find yourself going, ‘What was his name?‘, and you‘ll have these moments (of uncertainty) where, before, it was instantly there. I think it happens to everybody, but because there‘s Alzheimer‘s in the family, you wonder, ‘Is this an indication?‘ " she said.
The memory tests consist of viewing a series of objects, then faces, then the faces with names to them and a series of cards. The test then goes back to the faces and asks which names were associated with them. It also questioned the participant if he had seen a certain object before or something similar to it in the cards.
"A lot of the things were very similar. Like, one of the things was a fishing tackle hook, but maybe the end part was missing on it," Tiffany said. "So, you had to say it was similar as opposed to, ‘Yes, I‘ve seen this before.‘ "
Unlike studies in the past, the A4 trial is not looking for people who already have some degree of dementia.
"This is what‘s exciting about this project," Bernick said. "It‘s a shift in how we‘re thinking about Alzheimer‘s disease. In the past, it was about treatments for people who were already symptomatic. By the time you have dementia, the disease is already pretty advanced in your brain. It becomes much more difficult to treat them. So, we‘ve also recognized that the pathological process, or this buildup of the protein amyloid, occurs maybe up to 10 years before you have symptoms.
"It gives us a window of time where we believe if we can prevent the buildup of amyloid or remove it, you can actually slow the progression of the disease. This was never thought possible in the past, but we have two things that have changed the ball game. One is the PET scan — to determine if they are accumulating the amyloid in the brain, that‘s one thing. And the other is that now we have drugs that remove the amyloid. So, now we can identify people who are at the highest risk who are accumulating amyloid, even before their exhibiting symptoms, and then treat them."
The test will also help give a better understanding of the natural progression of the disease, especially in its early stages, and how accurate markers used in tests are in determining at what point in memory loss a patient is in.
"So, I think we‘re going to learn a lot about the disease process, the progression of it, in addition to (changes in) treatment at this stage," Bernick said. "There‘s a lot of excitement about this in the field."
Those selected to participate will be randomized to receive solanezumab or a placebo once every four weeks by intravenous infusion. Approximately 1,150 participants will be tested nationwide.
"We think this amyloid buildup is roughly like the issue of cholesterol," Bernick said. "We know the buildup of cholesterol is a risk factor for heart disease, so if you‘re going to treat that, you need to start early, many years before people show symptoms, before they have a heart attack, and I think that‘s the approach now we‘re doing with the brain. We‘ve identified these proteins, and now the question is whether these strategies to remove it will have an effect."
A PET scan determined that Tiffany had no amyloid plaque, so she could go no further with the solanezumab study. She vowed to find another study for which she qualified. Similarly, Robert E. Gaston, a retired judge, thought he would be a good candidate. He has no family history of Alzheimer‘s but, at 75, has noticed minor memory lapses and wanted to make a difference.
"How many times in our lifetimes do you get the opportunity to contribute to a health issue, to be a part of something that has worldwide implication?" he said of the study. He added that he‘d sometimes "walk into a room and not remember what I went in there for, or I‘d (misplace) my keys, small things like that. So, I figured it didn‘t hurt to get checked."
Like Tiffany, Gaston‘s PET scan found he did not have the suspect proteins, so he could not continue in the study. Getting more people to participate in the study is vital to learning about the disease, Bernick said.
Alzheimer‘s affects 5.5 million people in the United States. The A4 study is funded by the National Institutes of Health, Eli Lilly and Company, and various philanthropic organizations. Las Vegas is one of many sites where the study is being conducted. The clinical trial runs for 3 ½ years.
For more information on this trial and the Cleveland Clinic Lou Ruvo Center for Brain Health, call 855-568-7886, visit clevelandclinic.org/brainhealth or email firstname.lastname@example.org.
To reach Summerlin Area View reporter Jan Hogan, email email@example.com or call 702-387-2949.