Health officials have approved the first-ever treatment for early-stage dementia that can be administered at home. The Food and Drug Administration (FDA) announced Monday that it has approved an injectable form of lecanemab, also known as Leqembi Iqlik, for adults with Alzheimer's disease.
The drug is an amyloid-beta-directed antibody, targeting toxic proteins that form plaques in the brain and lead to neuron death in the brain's memory centers. Lecanemab received its initial FDA approval in July 2023, but at that time, it was only available for intravenous use in a clinical setting every two weeks.
The newly approved formulation is a subcutaneous injection, meaning it is administered under the skin. Patients or their caregivers can now administer this weekly injection at home. Previously, patients could only transition to maintenance injections after 18 months of the intravenous dosage, with those maintenance injections being approved in August 2025.
The FDA stated that this approval "marks the first time patients can begin treatment with home administration by themselves or their caregiver." Dementia experts suggest that increased accessibility and convenience of the drug could pave the way for additional treatments that can be initiated earlier in the disease progression.
"This approval represents an inflection point for Alzheimer’s treatment," said Isobel Coleman, chief executive officer of the Alzheimer's Drug Discovery Foundation. "As therapies become easier to administer, they create an opportunity to fundamentally rethink how we approach this disease, moving toward more dynamic treatment strategies in which therapies can be introduced, adjusted, and combined over time based on how the disease progresses in each individual."
The injectable version will be given in two 250mg doses weekly for several months, followed by a maintenance dose of 260mg. Details regarding when doctors will begin prescribing lecanemab and its cost remain unclear, though the intravenous form has a list price of $26,500 annually, with most insurance plans, including Medicare, providing substantial coverage.
This approval follows new data presented at the Alzheimer's Association International Conference, which showed that weekly 500mg injections of lecanemab were as effective as the intravenous dosages. A study unveiled in December 2025 at the Clinical Trials in Alzheimer's Disease conference also indicated that long-term lecanemab treatment could delay the progression of mild cognitive impairment to Alzheimer's by 8.3 years, specifically in patients with low amyloid levels who started treatment early.
Lecanemab functions by binding to amyloid-beta before it forms plaques. This action prompts microglia, immune cells in the brain, to clear the proteins and prevent their accumulation, thereby preserving healthy brain tissue and slowing cognitive decline.
The FDA noted that while the injectable form has not undergone separate large clinical trials, its approval is based on the established effectiveness of the intravenous form. Common side effects of lecanemab include headache, reactions at the injection site, and amyloid-related imaging abnormalities (ARIA), such as inflammation detected on brain scans. While ARIA typically resolves, it can rarely lead to brain swelling (edema) or seizures. ARIA is more prevalent in individuals with the APOE e4 gene, a known risk factor for Alzheimer's, leading the FDA to recommend genetic screening for patients prior to treatment. The FDA has also previously approved donanemab (Kisunla), another once-monthly infusion for early-stage Alzheimer's that operates similarly to lecanemab.