The Alzheimer's Digest: FDA approves new treatment for Alzheimer’s disease

Alzheimer’s disease currently affects more than 6.5 million Americans. The irreversible, progressive brain disorder slowly destroys memory, thinking skills, and overtime, the ability to carry out simple tasks. Even though the specific causes of the disease are not fully known, traits of Alzheimer’s are seen through changes in the brain, including amyloid beta plaques and neurofibrillary. These changes result in the loss of neurons and their connections, affecting a person’s ability to remember, think, and speak.

Recently, the US Food and Drug Administration approved Kisunla (donanemabazbt), an injection for the treatment of Alzheimer’s disease. The organization said the new treatment should be used in patients with mild cognitive impairment or at the mild dementia stage of the disease. Kisunla should also be administered as an intravenous infusion every four weeks.

The efficacy of the treatment was studied in a double-blind, placebo-controlled, parallel-group study in patients with Alzheimer’s disease. Before the start of the study, patients had confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. The study population had a mean age of 73 years, with a range of 59 to 86 years. 57% of patients were female, 91% were White, 6% were Asian, 4% were Hispanic or Latino, and 2% were Black.

For the first three doses, 1,736 patients were randomized 1:1 to receive 700 mg of Kisunla every four weeks and then 1,400 mg every four weeks or placebo for a total of up to 72 weeks. The treatment was switched to placebo based at Weeks 24, 52, and 76 on a prespecified reduction in amyloid levels measured by positron emission tomography (PET).

Patients who were treated with Kisunla showed a significant reduction in clinical decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS), the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog13), and the Alzheimer’s Disease Cooperative Study – instrumental Activities of Daily Living scale (ADCS-iADL), compared to placebo at Week 76. Patients with Kisunla also demonstrated a significant reduction in clinical decline on the Clinical Dementia Rating Scale, compared to placebo at Week 76.

While Kisunla has been approved, it’s safety information is important to note. When prescribed, the treatment comes with a boxed warning for amyloid-related imaging abnormalities (ARIA). ARIA presents itself as temporary swelling in areas of the brain, usually resolving over time. It also is accompanied by small spots of bleeding in or on the surface of the brain. Typically, ARIA does not have symptoms.

The most common side effects of Kisunla were ARIA and headache. The full prescribing information about Kisunla and its risks can be found here.