Walking 5000 Steps Slows Cognitive Decline
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new Alzheimer’s Drug Shows Promise in Slowing Cognitive Decline
Table of Contents
Understanding the Breakthrough
Recent clinical trial data indicates that donanemab, a new drug developed by Eli Lilly, demonstrates a significant slowing of cognitive decline in individuals with early symptomatic Alzheimer’s disease. The findings,presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in November 2023 and afterward published in the JAMA journal,offer a potential new avenue for treating this devastating disease. This represents a major step forward, though not a cure, in the fight against Alzheimer’s.
Key Findings from the TRAILBLAZER-ALZ 2 trial
The Phase 3 TRAILBLAZER-ALZ 2 trial involved 1,736 participants with early symptomatic Alzheimer’s disease and the presence of amyloid and tau protein buildup in the brain. Participants were randomly assigned to receive either donanemab or a placebo intravenously every two weeks for 18 months. The primary outcome measure was the change from baseline in the clinical Dementia Rating-Sum of Boxes (CDR-SB) score.
| Outcome Measure | Donanemab Group | Placebo Group |
|---|---|---|
| change in CDR-SB Score (18 months) | -2.0 | -1.2 |
| Percentage of Participants with Slowing of Decline ≥30% | 35% | 18% |
These results indicate that donanemab slowed cognitive and functional decline by 35% compared to placebo. Importantly, the drug targets amyloid plaques, a hallmark of Alzheimer’s disease, and removes them from the brain.
Potential Side Effects and Risks
Donanemab is not without potential side effects. The moast common adverse events observed in the trial included infusion-related reactions (chills, fever, nausea) and amyloid-related imaging abnormalities (ARIA), which can cause brain swelling or bleeding. ARIA occurred in approximately 24% of participants receiving donanemab, with most cases being mild or asymptomatic. Though, serious ARIA events, including those leading to hospitalization or death, were also reported.
Careful monitoring with MRI scans is crucial to detect and manage ARIA. Individuals with the ApoE4 gene, a genetic risk factor for Alzheimer’s, are at higher risk of developing ARIA.
FDA Review and Potential Availability
Eli Lilly submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for donanemab in June 2023.The FDA granted the application priority review, and a decision is expected in early 2024. If approved, donanemab would become the second disease-modifying therapy for Alzheimer’s disease, following aducanumab (Aduhelm) and lecanemab (Leqembi).
The cost of donanemab is expected to be significant, similar to other amyloid-targeting therapies. Access to the drug may be limited by insurance coverage and the need for specialized diagnostic testing and monitoring