Summary: Findings from a Phase 3 study show Donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease.
Donanemab met the primary endpoint of change, which measured measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events, from baseline until 18 months on the integrated Alzheimer’s Disease Rating Scale (iADRS).
All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits with similar magnitude.
Results suggest that people in the early pathological stage of Alzheimer’s could be the most responsive to therapeutics targeting amyloid.
Key Facts:
- Donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease.
- Participants on donanemab had significant reductions in brain amyloid plaque levels as early as 6 months after initiating treatment.
- The incidence of amyloid-related imaging abnormalities (ARIA) was consistent with the TRAILBLAZER-ALZ Phase 2 study, and most cases were mild to moderate and resolved or stabilized with appropriate management.
Source: Neuroscience News
Pharmaceutical company Eli Lilly has announced positive results from a Phase 3 clinical trial of its investigational Alzheimer’s disease drug, donanemab.
The trial found that the drug significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease, meeting both primary and secondary endpoints.
Donanemab works by targeting and clearing away amyloid plaques in the brain, a hallmark of Alzheimer’s disease. These plaques can contribute to inflammation and damage to brain cells, leading to cognitive decline.
Donanemab is a monoclonal antibody that targets a protein called amyloid-beta, which forms plaques in the brains of people with Alzheimer’s disease. The drug works by binding to the amyloid-beta protein and triggering an immune response that clears it from the brain. By removing these plaques, donanemab may slow down the progression of Alzheimer’s disease.
The Phase 3 trial of donanemab, called TRAILBLAZER-ALZ 2, enrolled over 1,700 patients with early symptomatic Alzheimer’s disease who had confirmed amyloid pathology.
The trial found that donanemab significantly slowed cognitive and functional decline in patients compared to placebo, meeting both primary and secondary endpoints. These results suggest that donanemab could be a promising treatment for Alzheimer’s disease.
The trial’s positive results have led to Lilly planning to submit the drug for regulatory approval in the US and globally.
If approved, donanemab could be a significant breakthrough for people with Alzheimer’s disease, as current treatments only address the symptoms and not the underlying causes of the disease.
It’s important to note, however, that there are associated risks with the drug, including potential life-threatening events such as serious amyloid-related imaging abnormalities, which were observed in the trial. As such, further research and monitoring of the drug’s safety will be important.
In addition to donanemab, there are several other drugs in development that aim to target amyloid plaques and other underlying causes of Alzheimer’s disease. If these drugs are successful, they could revolutionize the treatment of the disease and provide hope for the millions of people affected by Alzheimer’s around the world.
About this neuropharmacology and Alzheimer’s disease research news
Author: Press Office
Source: Neuroscience News
Contact: Press Office – Neuroscience News
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