Alzheimer's clinical trial tests new drug, new approach
Researchers have high hopes for the new Alzheimer's drug solanezumab, which is being used in the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease study (known simply as "A-4"), as CBS News' Wyatt Andrews reported Tuesday on the CBS Evening News in this story: New trial to treat Alzheimer's "game changing."
Manufactured by Eli Lilly, the drug is is being tested on people ages 65 to 85 who have been diagnosed with Alzheimer's but are not yet showing any symptoms. This kind of clinical trial has never before been undertaken in the study of Alzheimer's. Its goal is to stop the disease in its tracks, to prevent the most devastating symptom of the onset of the disease: memory loss.
Dr. Reisa Sperling of Brigham and Women's Hospital in Boston is the director of the A-4 study. "Our volunteers have evidence of the earliest brain changes, the amyloid plaque buildup that we think leads to dementia," she said.
Researchers believe the amyloid plaque kills brain cells, causing the loss of memory and other brain function. So, 3,000 people who are currently symptom-free will undergo PET scans to determine if they have an elevated level of amyloid in the brain. If they do, they can volunteer for the A4 study. About one-third of those tested will take part in the study at 60 hospitals and clinics nationwide.
Although there were a few drugs that showed promise for the A4 study, solanezumab was selected for at least two reasons. "It has a good safety profile, which is a big deal when giving a drug to clinically normal people," said Sperling, who was quoted on Alzforum, a web-based forum of scientists trying to understand Alzheimer's. Earlier trials on patients with mild symptoms had shown a little improvement, and scientists thought that a new study on asymptomatic patients, "before symptoms are present, as well as treating for a longer period of time" could even "slow cognitive decline and ultimately prevent Alzheimer's disease dementia."
Sixty-six year-old Helene deCoste is participating in the study. Her mother died of Alzheimer's disease and donated her brain to Harvard University for research. Her sister Judith, who is six years older, and was a chemistry professor, also suffers from Alzheimer's.
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"And I just feel like I'm always forgetting things, so I said well, maybe I have it, or I have the beginnings of it," deCoste told CBS News.
The A4 trial demands that Helene get an IV infusion every month for 36 months, and the odds that she's getting Solanezumab are only 50-50. Half of the volunteers are being given the drug, and the other half are getting a placebo. Either way, she says she is happy to participate. "To me, it's a good thing because I can be in this study," Helene said, "and maybe I'll be able to benefit by getting this medication if this study proves that it works."
Sperling knows what the participants are enduring. Her grandfather died of Alzheimer's while she was a medical student, and her father was diagnosed with the disease last year. "Every day counts," said Sperling. "Every day that we don't have enough people to fill these trials is another day we don't have an answer."
And as the American population ages, the need to find a treatment for Alzheimer's is becoming more urgent. It's an expensive disease to treat - the Alzheimer's Association estimates that this year, Alzheimer's and other dementias will cost Americans $226 billion - and Medicare will pick up about half of that bill. By 2050, Alzheimer's will be a trillion-dollar malady.
In 2011, Congress passed the National Alzheimer's Project Act, which sets the ambitious goal of preventing and effectively treating Alzheimer's by 2025 and requires annual progress reports and budgets from researchers. This fiscal year, researchers will get $560 million in federal funding, an increase over past years, but still short of the $2 billion the Alzheimer's Association estimates will be needed each year, if researchers are to reach their goal. Lawmakers will receive an update on the progress made at a hearing on Wednesday.
To volunteer for the A4 study and other Alzheimer's disease research, go to the website a4study.org,or call 1-844-A-4-STUDY (1-844-247-8839).