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Imaging agents for Alzheimer’s disease in late-stage clinical trials will be used first to rule out the disease, rather than to diagnose it, companies working on the agents say.
They envision tests such as Avid Radiopharmaceuticals’ Florbetapir F 18, as a way to help doctors decide if a patient has Alzheimer’s – an incurable disease – or something like depression they could treat.
Ultimately, such tests could be part of a full range of tests used to give early warning of Alzheimer’s, which affects 26 million people globally and costs US$604 billion to treat.
Acquired by Eli Lilly and Co last month, Avid leads a three-way race with General Electric Co and Bayer AG to be the first to market an imaging agent that can detect Alzheimer’s plaques in people’s brains.
That gives Avid an advantage, but it also gives rivals a chance to learn from the company’s mistakes, said Dr Daniel Skovronsky, Avid founder and chief executive.
“This is a completely new and very innovative area. No one has done it before. We’re making it up as we go along,” Skovronsky told Reuters in a telephone interview.
The company recently published full results of its late-stage clinical trial of Florbetapir that showed the test worked well at finding clumps of a protein called beta amyloid in the brains of patients with Alzheimer’s disease.
Skovronsky said the trial helped to show how much amyloid needed to be present before the scan turned positive.
“We don’t really get a positive scan if you have just one or two plaques. You have to get beyond sparse pathology,” he said. But given that amyloid likely forms deposits as much as a decade before symptoms occur, Skovronsky said the test will still likely detect signs of the disease early on. – Reuters Life!
“Do I think it should be the first diagnostic test used? Certainly not,” he said.
He said doctors should continue to use conventional tests to screen for possible Alzheimer’s. And he said other teams are developing blood tests to screen for the disease.
“We would love it if there was some blood test that was cheaper and readily available and could be used as a triage for screening of patients,” Skovronsky said. “So far, there hasn’t been anything that has been validated.”
Jonathan Allis, who leads GE Healthcare’s PET (positron emission tomography) medical diagnostics unit, sees a similar development scenario.
GE paired up last month with Johnson & Johnson to look for early signs of Alzheimer’s disease.
“It’s very very clear that Alzheimer’s disease is going to be best treated when you catch someone very early,” Allis said in a telephone interview.
He said tests of the company’s PET imaging agent called Flutemetamol are going well, and the company is also testing other imaging methods, such as magnetic resonance imaging or MRI and what he called “clever software” to give even more confidence in the diagnosis.
Allis agrees the first imaging tests for Alzheimer’s will be to rule out the disease, but eventually he hopes there will be enough evidence for a positive early diagnosis of the disease, using a range of tests.
“Early diagnosis is very important,” he said.
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