Jul 18, 2023

By Jane Brown

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There is optimism at the Alzheimer’s Society of Ontario over the release of full clinical trial data from phase three testing of donanemab.

This is a new treatment candidate for Alzheimer’s disease developed by Eli Lilly.

Cathy Barrick is CEO of the Alzheimer’s Society of Ontario and says “for the first time ever, there are now multiple promising treatment options for people at the earlier stages of Alzheimer’s disease.”

Donanemab reported high-level, unpublished results in May 2023, and Monday’s full results reinforce the broadly positive outcomes. As previously shared, donanemab slowed cognitive decline by 35-percent versus placebo. Monday’s full results show that these reductions are greater among trial participants with mild cognitive impairment, with cognitive decline slowed by 60-percent. This reinforces the need to detect, diagnose, and treat Alzheimer’s disease at the earliest possible stage.

Eli Lilly experts are asking the U.S. Food and Drug Administration to approve its experimental Alzheimer’s drug.

It says donanemab can modestly slow a patient’s inevitable worsening by about four to seven months.

The company has just released the full results of a study of 1700 patients at the Alzheimer’s Association International Conference in Amsterdam.

Trial results also revealed the presence of amyloid-related imaging abnormalities (including brain bleeding and swelling) in 36.8-percent of trial participants, more than double that recorded in the placebo group. As with all drugs of this type there is a risk of side effects, some serious, and anyone considering accessing a pharmacological treatment for Alzheimer’s disease should consult their health care provider.

Like the drug Leqembi, it comes with a serious safety concern — brain swelling or bleeding that in the Lilly study was linked to three deaths.

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