Dr. Brian R. Ott is director of the Alzheimer’s Disease and Memory Disorder Center at Rhode Island Hospital, a Lifespan facility, and a professor of neurology at The Warren Alpert School of Medicine of Brown University. He received his training in neurology at the Harvard Medical School Longwood Program in Boston and his medical degree from the Jefferson Medical College of Thomas Jefferson University in Philadelphia, Pa.
A lead investigator at Rhode Island Hospital for an international clinical trial, Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4), to test a drug to evaluate its benefits in reducing the risk of developing Alzheimer’s disease, Ott talked with Providence Business News about the clinical trial.
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PBN: Can you describe the drug being tested in this clinical trial, and what do researchers hope it will achieve?
OTT: The A4 study is testing an anti-amyloid investigational drug in older individuals who have evidence of elevated amyloid accumulation in their brain but who do not yet show symptoms of Alzheimer’s disease. Years before Alzheimer’s disease symptoms appear, some people develop abnormal clumps of matter called amyloid plaques in their brains. When these amyloid plaques build up, they can interfere with how the brain normally works and cause problems with memory and thinking. Research has found that people with high levels of brain amyloid are more likely to have memory decline, and many, but not all, will eventually develop Alzheimer’s disease. This drug, solanezumab, targets the amyloid plaques with an antibody that we hope will slow the progression of memory loss associated with Alzheimer’s by binding to the amyloid proteins.
The key is early intervention. This is similar to the approach that has proven fairly successful in reducing heart attacks and strokes from atherosclerotic plaques in vessels by using statins and antihypertensive drugs to reduce plaque burden before the heart attack or stroke can occur.
PBN: The study has been going on for some time; has the drug being studied shown any efficacy to date in preventing Alzheimer’s?
OTT: This is actually the first study of solanezumab to determine if it may help to prevent the progression of Alzheimer’s, when administered before there is evidence of Alzheimer’s symptoms and brain injury. Earlier solanezumab trials included Alzheimer’s patients with well-established disease without success. But the lesson learned from those trials was that indications of positive trends suggested that the medication may still be effective if used much earlier in the stage of the disease, which is what we’ve begun examining now.
PBN: Who is eligible to participate in the trial and what’s involved in participating?
OTT: Healthy people, ages 65-85, with normal memory are needed to join the clinical trial. Amyloid in the brain can be seen by using a special type of brain scan called an amyloid Positron Emission Tomography scan. Potential participants undergo a PET scan to measure amyloid in the brain. Participants with normal thinking and memory abilities and an elevated amyloid level who pass screening evaluations of their general health will be randomly assigned to receive either the investigative antibody drug or a placebo, given by an intravenous infusion every month. Participants will be monitored for the duration of the three-year trial. All of the screening and medication costs are covered by funding for the trial.
PBN: How many people is Rhode Island Hospital seeking to recruit for the study?
OTT: We are seeking to enroll at least 20 volunteers. To do this we need to screen an additional 100 volunteers this year for potential participation.
PBN: Rhode Island Hospital is just one of several venues where this drug is being evaluated. When do you and your fellow researchers expect to have some results?
OTT: This multicenter trial has already reached about 75 percent of the total international enrollment goal of 1,150 participants, but we still have a way to go to reach the finish line. The study would like to complete enrollment this year, and then results will be analyzed after the next three years. While this may seem like a long time to wait, it is important to realize that it takes this long to be able to see if we have been able to change the long-term course of this chronic disease through early intervention. The sooner that we can complete our enrollment, the sooner we will get the answer.
Nancy Kirsch is a PBN contributing writer.
