The National Institutes of Health (NIH) is working on a new Alzheimer’s drug, but the drug’s approval hinges on a controversial, $10 billion clinical trial that has not yet begun.
The trial, which will test whether a drug that targets a protein found in A. plasminogen spirochaetes can slow the progression of the disease, could cost the government more than $40 billion.
But some are concerned about the safety of the drug, which could be the first of its kind to target the protein that causes Alzheimer’s disease.
“We’re not going to see this drug on the market until we see it in a clinical trial,” said Andrew Weil, the director of the Alzheimer’s Disease Association.
“And then it’s a long wait to see if we can find a way to stop the progression.
We are hoping for a very long wait.”
The drug, called Amyloid-beta, was approved by the FDA last month.
The drug works by targeting a protein called Aβ, which is the same protein that leads to Alzheimer’s.
The new study, led by the NIH, will test Amyloids in mice that were given a drug with similar effects to the drug currently on the U.S. market, called moclobemide.
The treatment is being tested in the first phase of the trial, but a final decision will not be made until at least the second phase.
“It’s been a long process to get to this point,” said Dr. David Hirsch, a professor of neurology at Harvard Medical School and one of the study’s lead investigators.
The first clinical trial for the drug began in September 2018.
It involved 2,300 patients, of whom more than 600 received a treatment with moclosetine, a drug approved for other conditions.
That study showed a small decrease in Aβ plaque, or protein deposits, in mice treated with mclosetide.
But a follow-up study showed that the plaque levels were not significantly different between the two groups.
Dr. Hirsch said it is unclear if that finding would translate to humans.
The next step will be to test whether the drug can block the protein in the same way.
“The question is, what does that do?
Are we getting the same benefit?”
Dr. Weil said.
“There are a lot of questions about the drug and the efficacy.
The National Institute on Aging (NIA) is a private, nonprofit organization with headquarters in Bethesda, Maryland. “
If the drugs are successful, they will be the only one out there.”
The National Institute on Aging (NIA) is a private, nonprofit organization with headquarters in Bethesda, Maryland.
The NIA is the lead agency in the U-M Alzheimer’s Drug Trials program.
The NIH has been working on Alzheimer’s drugs for about a decade.
It has the largest Alzheimer’s research budget in the world, with about $2.6 billion.
The agency says the cost of testing drugs to determine safety and effectiveness is about $1 billion a year.
The National Academy of Sciences is an independent nonprofit organization that reviews and approves new drugs for use in humans.
A study published in February showed that Amylo-beta’s results are promising, and the agency expects to see results from the trial soon.
The trials are being funded by the U, M and the NIH.
The clinical trial is expected to be completed by mid-2019.