The drug Donanemab significantly slows cognitive and functional decline in people with early symptomatic Alzheimer’s disease

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Alzheimer’s disease is a debilitating neurodegenerative disorder that affects millions of people worldwide. Currently, there are no effective treatments to cure or halt the progression of this disease..

However, recent research has shown promising results with the use of the drug donanemab, which has been shown to significantly slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease.

Donanemab is a monoclonal antibody that targets a specific type of beta-amyloid protein, which is believed to play a key role in the development and progression of Alzheimer’s disease. In a phase 2 clinical trial, donanemab was administered intravenously once a month for up to 18 months to a group of 257 people with early symptomatic Alzheimer’s disease.

The trial, known as TRAILBLAZER-ALZ, was a randomized, double-blind, placebo-controlled study. The participants were assigned to either receive donanemab or a placebo. The primary endpoint of the study was a change in the Integrated Alzheimer’s Disease Rating Scale (iADRS) from baseline to 76 weeks. The iADRS is a composite score that measures both cognitive and functional abilities.

The results of the study showed that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. The mean change in the iADRS from baseline to 76 weeks was -6.86 in the donanemab group compared to -10.24 in the placebo group. This represents a 32% reduction in decline in the donanemab group compared to the placebo group.

In addition to the primary endpoint, the study also showed significant improvements in secondary endpoints such as the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB). The study also showed a reduction in the amount of beta-amyloid plaques in the brains of the participants who received donanemab.

The safety profile of donanemab was also evaluated in the study. The most common adverse events were amyloid-related imaging abnormalities (ARIA), which were observed in 27% of the participants who received donanemab compared to 3% of the participants who received a placebo. However, the ARIA events were generally mild or moderate and resolved spontaneously or with treatment.

Overall, the results of the TRAILBLAZER-ALZ study suggest that donanemab is a promising treatment for people with early symptomatic Alzheimer’s disease. The study showed significant improvements in cognitive and functional abilities and a reduction in beta-amyloid plaques in the brain.

Findings from a Phase 3 study show Donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease.

The Phase 3 trial of donanemab, called TRAILBLAZER-ALZ 2, enrolled over 1,800 patients with early symptomatic Alzheimer’s disease who had confirmed amyloid pathology.

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:

  1. Donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease.
  2. Participants on donanemab had significant reductions in brain amyloid plaque levels as early as 6 months after initiating treatment.
  3. 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.


reference link:https://www.clinicaltrials.gov/ct2/show/NCT04437511

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