Alzheimer's drug targeting soluble amyloid falls short in a large clinical trial

January 25, 2018, Columbia University Medical Center
Left: "Negative" scan, without Alzheimer's disease pathology. Right: "Positive" scan of patient eligible for Solanezumab clinical trial. Credit: Columbia University Medical Center

A paper published today in the New England Journal of Medicine reports that solanezumab, a monoclonal antibody-based treatment for Alzheimer's disease developed by Eli Lilly that targets amyloid plaques, did not significantly slow cognitive decline.

Columbia University Irving Medical Center (CUIMC) led the multicenter study.

Researchers have proposed that Alzheimer's disease is caused by the buildup of a sticky protein called beta-amyloid. According to this 'amyloid hypothesis,' the protein forms plaques in the brain that damage and eventually destroy brain cells. Solanezumab was designed to reduce the level of soluble amyloid molecules before they aggregate.

A total of 2,129 patients with due to Alzheimer's disease participated in the double-blind, placebo-controlled, phase 3 multicenter trial. This study was the first major Alzheimer's clinical trial to require molecular evidence of in the brain for enrollment. While the treatment did have some favorable effects, in the main measure of outcome—measured with a cognitive test called the Alzheimer's Disease Assessment Scale-cognitive subscale—the researchers did not observe any statistically significant benefit compared with placebo.

The authors suggest that while it is not certain that this particular strategy or could be effective, it is possible that either not enough drug was administered or that the drug needs to be administered earlier in the disease course.

In other studies ongoing at CUIMC, solanezumab is being evaluated in presymptomatic patients at risk of Alzheimer's disease. Other Alzheimer's drugs are also in development and being tested at higher doses.

"Although we are disappointed that this particular drug did not prove successful, the field is benefiting from each study," says lead author Lawrence Honig, MD, PhD, professor of neurology at CUIMC. "There is hope that one of the newer ongoing studies may result in an effective treatment for slowing the course of Alzheimer's disease."

The study is titled, 'Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease.'

Explore further: An Alzheimer's drug fails, but many others still in testing

More information: Lawrence S. Honig et al. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. New England Journal of Medicine, 2018; DOI: 10.1056/NEJMoa1705971

Related Stories

An Alzheimer's drug fails, but many others still in testing

November 23, 2016
Another major Alzheimer's drug study has failed, leaving patients and families wondering if there ever will be a treatment to slow or reverse the most common form of dementia, which afflicts more than 5 million in the United ...

Positive results from Alzheimer's drug in Phase 1 clinical trial extension

November 3, 2017
The pharmaceutical company Biogen has today announced the results of an extended phase 1b clinical trial of the potential Alzheimer's disease drug, aducanumab. Results from the extended early stage trial, were announced today ...

Trial drug shows 'impressive' Alzheimer's action: study

August 31, 2016
An experimental drug cleared protein buildup in the brains of people with mild Alzheimer's disease and slowed their mental decline, the results of a preliminary trial showed Wednesday.

Lilly stops mid-stage Alzheimer's drug study (Update)

June 13, 2013
Eli Lilly and Co. said Thursday that it stopped a mid-stage clinical trial of an experimental Alzheimer's disease drug because of potential side effects on patients' livers.

Merck halts trial of once 'promising' Alzheimer's drug

February 15, 2017
US pharmaceutical giant Merck announced it is halting a clinical trial on a drug once touted as a promising treatment for Alzheimer's disease, saying studies show it does not work.

Novel approaches to treating Alzheimer's disease include early intervention

May 16, 2012
(Medical Xpress) -- Researchers at the Comprehensive Alzheimer’s Program at the University of California, San Diego School of Medicine have announced two new clinical trials for patients with either mild to moderate ...

Recommended for you

New discoveries predict ability to forecast dementia from single molecule

December 11, 2018
Scientists who recently identified the molecular start of Alzheimer's disease have used that finding to determine that it should be possible to forecast which type of dementia will develop over time—a form of personalized ...

Researchers classify Alzheimer's patients in six subgroups

December 5, 2018
Researchers studying Alzheimer's disease have created an approach to classify patients with Alzheimer's disease, a finding that may open the door for personalized treatments.

Neuroscientists pinpoint genes tied to dementia

December 3, 2018
A UCLA-led research team has identified genetic processes involved in the neurodegeneration that occurs in dementia—an important step on the path toward developing therapies that could slow or halt the course of the disease. ...

Detecting signs of neurodegeneration earlier and more accurately

November 30, 2018
Signs of neurodegenerative diseases, appearing years before the emergence of clinical manifestations, can be detected during the examination of medical samples by means of fluorescence microscopy by using new sensitive and ...

Never-before-seen DNA recombination in the brain linked to Alzheimer's disease

November 21, 2018
Scientists from Sanford Burnham Prebys Medical Discovery Institute (SBP) have identified gene recombination in neurons that produces thousands of new gene variants within Alzheimer's disease brains. The study, published today ...

New information on the pathological mechanisms of Alzheimer's disease

November 21, 2018
Researchers at the University of Helsinki have discovered a mechanism by which harmful tau protein aggregates are transmitted between neurons. Alongside amyloid plaques, tau aggregates in the brain are a significant factor ...

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.