New Alzheimer’s drug shows low brain-bleed risk in trial
Existing drugs that clear amyloid from the brain can cause small brain bleeds or brain swelling in some patients. A new drug in an early clinical trial showed very little of this. Whether it actually works remains unknown.
Amyloid is a protein that accumulates into plaques in the brains of Alzheimer’s patients. Drugs targeting these plaques exist and have been approved in the US. But they carry a notable risk: a side effect called ARIA (amyloid-related imaging abnormalities). ARIA has two forms: tiny brain bleeds (ARIA-H) and brain swelling (ARIA-E, the more serious variant).
What did the interim data show?
ProMIS Neurosciences is conducting a clinical trial of an amyloid-targeting drug. A blinded interim analysis pooling safety data from patients receiving the drug and those receiving a placebo showed a total ARIA rate of 4.4%. All cases were mild and asymptomatic. No patient experienced ARIA-E. The researchers reported these interim safety findings.
For comparison, approved drugs such as lecanemab and donanemab carry substantially higher ARIA rates. ARIA-E occurs in a portion of patients on those drugs and can be serious in rare cases.
What remains unknown?
An important caveat: the analysis was blinded, meaning patients who received the drug had not yet been separated from those who received a placebo. The specific ARIA rate in the treated group alone is therefore still unknown. Whether the drug actually clears amyloid and offers cognitive benefit cannot be determined from this interim analysis.
The results are promising on the safety front but should be interpreted with caution. Early safety data say little about efficacy. It is worth watching whether a safer amyloid approach is achievable, but this is not yet a clinically proven advance.
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