The Clarity AD clinical trial studied Leqembi in people with early Alzheimer’s disease. After the initial study, many participants chose to continue in an open-label extension (OLE) phase, where everyone received Leqembi.
In this phase, some participants were given intravenous (IV) Leqembi once every 4 weeks, while others tried different doses of subcutaneous (SC, under the skin) Leqembi.
The results showed that stopping treatment led to a gradual return of amyloid in the brain, whereas continuing treatment beyond 18 months helped keep lowering amyloid levels and maintain clinical benefits.
On January 26, 2025, the FDA approved maintenance treatment with IV Leqembi once every 4 weeks. After completing 18 months of IV Leqembi every 2 weeks, patients can either stay on the same dose or transition to the every-4-week maintenance dose.
On August 29, the FDA approved LEQEMBI® IQLIK™ (pronounced “I-click”), a once-weekly injection administered under the skin for maintenance treatment. After completing 18 months of IV Lecanemab every 2 weeks, patients may switch to this self-injection form, which can be self-administered at home. Compared to the IV form, this is convenient and well-tolerated. Some people may notice reactions (redness, itching) at the injection site.
Other side effects, including bleeding or swelling in the brain (ARIA), can occur with Leqembi during both the starting and maintenance phases. These side effects are most common during the first six months of treatment and are not expected to increase during the maintenance phase, and their rates are similar with SC and IV treatments.
It is important for individuals completing the first 18 months of Leqembi treatment to talk with their clinician about maintenance options in order to review the risks and benefits of IV versus SC treatment to decide whether continuing therapy is right for them.
Find updated prescribing information for maintenance treatment here.
