In a small medical trial, an experimental Alzheimer’s drug slowed down the rate at which sufferers lost the power to think and take care of themselves, drug maker Eli Lilly announced Monday.
These results have not been published in any form, and have not been widely reviewed by other researchers. If true, this is the first time a so-called Phase 2 study has yielded a positive result, said Dr. Lone S. Schneider, a professor of psychology, neurology and gerontology at the University of Southern California.
Other experimental drugs against Alzheimer’s have never been tested in Phase 2 trials, they went straight to major Phase 3 trials, or failed to yield positive results. Phase 3 studies themselves have repeatedly yielded disappointing results.
In a two-year study, 272 patients with brain scans were diagnosed with Alzheimer’s disease. Their symptoms are mild to moderate.
The drug is attached to a small piece of hard plaque in the brain made up of an antibody, a drug, a protein, amyloid, which is a symptom of Alzheimer’s disease. Patients received injections every four weeks.
Participants who received the medication had a 32% reduction in the rate of reduction compared to those who had placebo. The board’s chief scientific officer, Dr. Daniel Skoronsky, said the plaques were gone in six to 12 months. At this point, the patients stopped receiving the medicine – for the study period, they got a placebo instead.
Dr. Michael Weiner, a well-known Alzheimer’s researcher at the University of California, San Francisco, notes that this small study needs to be replicated. Still, “this is great news,” he said. “It gives hope to patients and their families.”
Dr. Schneider said Eli Lilly did not release the appropriate data for the full analysis. For example, the company provided only percentages to describe a lack of function in participants, not actual numbers.
Dr. Skaowski said the company would provide the data later in the meeting and in an article in the medical journal. He said Eli Lilly received the results on Friday and needed to be notified immediately, as the results could affect Lily’s stock.
Dr. Schneider, who served on the Independent Data Safety and Monitoring Board for the study, said he was not allowed to disclose any data beyond the company provided.
The trial serves as a test of the so-called amyloid hypothesis. Alzheimer’s is thought to be linked to the accumulation of amyloid in the brain. If amyloid accumulation can be prevented or reversed, the disease can be prevented or treated.
Pharmaceutical companies have spent billions of dollars testing anti-amyloid drugs, which has led many experts to believe that this assumption is wrong – or that the only way to treat Alzheimer’s is to start too soon. Before there are any symptoms of the disease.
The Eli Lilly trial recruited patients not on the basis of symptoms but on the basis of significant amyloid accumulation scans in their brains. The researchers also scanned for a protein, Tau, which forms spaghetti-like complexes in the brain after the onset of the disease.
“We needed a mild to moderate complex pathology, but not so complicated that the disease might be beyond hope,” said Dr. Skvoronsky.
The main end of the trial, or target, was a measure that combined reasoning and memory mental experiments with estimates that participants participated in everyday tasks such as dressing their lives and preparing food. What a wonderful way to screw people over.
Fluid accumulation in the brain: Its main side effects are regularly seen in patients given experimental monoclonal antibodies for the treatment of Alzheimer’s. Dr. Skvoronsky said it happened in about 30 percent of patients, but most had no symptoms. The effect was seen on brain scans.
While the trial was underway, Eli Lilly launched Phase 2 Trial Blazer 2, hoping that the initial attempt would yield results. These results are expected in 2023.
Dr. Skarovinsky said Eli Lilly would talk to Food and Drug Administration and regulatory authorities in other countries to help patients gain access to drugs.
“The figures are definitely interesting,” he said. “But we have to see what the regulators say.”
He had been hoping for 25 years for the proof that amyloid speculation was true.
“That’s what we’re looking forward to,” Dr. Skvoronsky said.