Alzheimer's drug fails study but flashes potential

August 24, 2012 by TOM MURPHY

(AP)—An Alzheimer's treatment from Eli Lilly and Co. failed to slow memory decline in two separate patient studies, but the drug did show some potential to help in mild cases of the mind-robbing condition that is notoriously difficult to treat.

The Indianapolis drugmaker's announcement could be a step toward a long-awaited breakthrough in the fight against the disease. But researchers not tied to the studies—and Eli Lilly itself—cautioned against overreacting to the initial results.

Lilly said Friday that its treatment, solanezumab, failed to slow the rate of cognitive decline, which involves a person's ability to remember things, in two late-stage studies of about 1,000 patients each. But when data from the trials were combined, scientists saw a statistically significant slowing of that rate in the bigger population.

They also saw a statistically significant result when they examined a subgroup of patients with mild cases of Alzheimer's disease. The studies focused on patients with mild to moderate Alzheimer's cases.

Lilly officials would not discuss details of the results and said that they plan to talk with regulators about the next steps for the drug, which has yet to receive Food and Drug Administration approval. Full results from the studies will be presented at two scientific conferences in October. It's unclear how the FDA will view the results, given that the drug missed its main goals.

William H Thies, chief medical and scientific officer for the Alzheimer's Association, which was not involved in Lilly's research, said the statistical significance of the combined results is important.

"If that can be replicated, that is a major finding," he said. "It's the first time we've been able to change the course of Alzheimer's disease or any part of Alzheimer's disease in people."

But because the drug missed its main goals, Thies said the drug "isn't going to the (FDA) tomorrow to be approved for sale."

If you look through "rose-colored glasses" at the results, there may be a sign of potential benefit on cognitive tests, said Dr. Ronald Petersen, director of the Mayo Clinic's Alzheimer's Disease Research Center. But it is not clear whether that is enough to make a real difference clinically in how patients do, he said.

The key will be details the company will present later on brain imaging and other tests, he said.

"The danger would be an over-interpretation of a small finding or a subtle effect," said Petersen, who heads a safety monitoring panel for two companies working on a different Alzheimer's treatment.

About 35 million people worldwide have dementia, a term for brain disorders that affect memory, judgment and other mental functions. Alzheimer's is the most common type. In the United States, more than 5 million people have Alzheimer's, which is the country's sixth-leading cause of death.

Many Alzheimer's patients typically live four to eight years after diagnosis, as the disease gradually erodes their memory and ability to think or perform simple tasks. Current Alzheimer's treatments only temporarily ease symptoms such as memory loss, confusion and agitation. They don't slow, stop or reverse mental decline.

Drugmakers have tried and failed for years to develop successful treatments for the disease, and patients and doctors are anxious for something that can slow the disease's progression. Analysts have said such a treatment, if approved, could be worth billions of dollars in sales.

AP Chief Medical Writer Marilynn Marchione in Milwaukee contributed to this report.

Explore further: Pfizer and J&J end development of Alzheimer's drug

shares

Related Stories

Pfizer and J&J end development of Alzheimer's drug

August 6, 2012
Pfizer Inc. and Johnson & Johnson say they are ending development of a once-promising drug designed to treat Alzheimer's disease after the treatment failed in two late-stage clinical trials.

Alzheimer's drug fails in 1 study, 2nd continues (Update)

July 23, 2012
(AP) — A closely watched experimental Alzheimer's treatment has failed to slow the disease in one late-stage study, a big disappointment for doctors and patients but not the end of the road for the drug. Pfizer Inc. ...

Evidence lacking for efficacy of memantine in treating mild Alzheimer's disease

April 11, 2011
An analysis of studies involving the drug memantine finds a lack of evidence for benefit when the drug is used to treat patients with mild Alzheimer disease, according to a report posted online today that will appear in the ...

Alzheimer's drug shows promise in early trial

July 18, 2012
(HealthDay News) -- Researchers say an investigational drug helped improve memory, language, attention and other mental skills in people with early Alzheimer's disease.

Recommended for you

Zika virus stifles pregnant women's weakened immune system to harm baby, study finds

August 21, 2017
The Zika virus, linked to congenital birth defects and miscarriages, suppresses a pregnant woman's immune system, enabling the virus to spread and increasing the chances an unborn baby will be harmed, a Keck School of Medicine ...

Novel approach to track HIV infection

August 18, 2017
Northwestern Medicine scientists have developed a novel method of tracking HIV infection, allowing the behavior of individual virions—infectious particles—to be connected to infectivity.

Faulty gene linked to obesity in adults

August 18, 2017
Groundbreaking new research linking obesity and metabolic dysfunction to a problem in the energy generators in cells has been published by researchers from the Harry Perkins Institute of Medical Research and The University ...

Two lung diseases killed 3.6 million in 2015: study

August 17, 2017
The two most common chronic lung diseases claimed 3.6 million lives worldwide in 2015, according to a tally published Thursday in The Lancet Respiratory Medicine.

New test differentiates between Lyme disease, similar illness

August 16, 2017
Lyme disease is the most commonly reported vector-borne illness in the United States. But it can be confused with similar conditions, including Southern Tick-Associated Rash Illness. A team of researchers led by Colorado ...

Addressing superbug resistance with phage therapy

August 16, 2017
International research involving a Monash biologist shows that bacteriophage therapy – a process whereby bacterial viruses attack and destroy specific strains of bacteria - can be used successfully to treat systemic, multidrug ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.