Medications that may change disease progression (only for appropriate individuals with “mild cognitive impairment”)
After many years, there have been recent advancements in the development and understanding of treatments for Alzheimer's and other forms of dementias. Most notably there has been advancement in drugs that change disease progression.
Drugs in this category slow disease progression by going after the underlying biology of the disease process. They aim to slow the decline of memory and thinking, as well as function, in people living with Alzheimer's disease. It’s important to note, that these drugs are only indicated for use in people with mild cognitive impairment (MCI).
Donanemab (Kisunla™)
Donanemab is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. It is approved to be initiated in patients with mild cognitive impairment or mild dementia stage of disease
It is an infusion IV therapy, administered over approximately 30 minutes every 4 weeks.
As of July 2024, Donanemab has received accelerated approval from the FDA and is covered by Medicare and other insurance carriers; The price of Donanemab is approximately $32,000 per year (not including drug administration and monitoring costs). Medicare will cover 80% of the costs and supplemental insurance (if you have any) may help may with the remaining amount. There may also be additional costs to pay for medical visits, infusions and regular brain scans associated with treatment.
Donanemab has been shown to slow the progression of cognitive and functional decline in patients with early Alzheimer's disease. In clinical trials, it reduced the progression of Alzheimer's by about 29% to 35% compared to a placebo, depending on the study
A significant risk associated with Donanemab is the potential for ARIA, which can manifest as brain swelling (edema) or microhemorrhages (small brain bleeds). While many cases are asymptomatic, ARIA can lead to serious complications in some patients
Side Effects: Other common side effects include headache, confusion, dizziness, and nausea. These side effects need to be managed carefully, especially in elderly patients who are more vulnerable to adverse reactions
Access and Monitoring Requirements: Due to the risks, patients on Donanemab require regular monitoring through MRI scans to detect ARIA and other potential issues.
Lecanemab (Leqembi™)
Lecanemab is an anti-amyloid antibody therapy indicated for the treatment of Alzheimer’s disease. It is approved to be initiated in patients with mild cognitive impairment (MCI) or mild dementia with confirmation of elevated beta-amyloid.
It is an infusion IV therapy, administered over approximately one hour every two weeks.
In July 2023, it gained full FDA approval and is covered by Medicare and by other insurance carriers; The price of Lecanemab is $26,500 per year (not including drug administration and monitoring costs). Medicare will cover 80% of the costs and supplemental insurance (if you have any) may help may with the remaining amount of $6,600. There may also be additional costs to pay for medical visits, infusions and regular brain scans associated with treatment - this may increase the patient out of pocket cost to $18,000 a year.
In a large clinical trial, Lecanemab was shown to slow decline by 5.3 months over a period of 18 months for those patients on the drug.*
The most common reported serious side effects were infusion-related reactions and amyloid-related imaging abnormalities (ARIA), a common side effect that does not usually cause symptoms but can be serious. It is typically a temporary swelling in areas of the brain. It usually resolves over time.
In a large clinical trial, 13% of patients receiving lecanemab experienced brain swelling, but most of those cases were mild or moderate. Less than 2% of patients receiving the placebo experienced such swelling. Most brain swelling did not cause any symptoms and generally resolved within a few months.
About 17% of patients receiving lecanemab experienced brain bleeding, compared with 9% of patients receiving the placebo. The most common symptom from brain bleeds was dizziness.
Patients at higher risk for swelling or bleeding in the brain are those on blood thinners, those with more than four microscopic bleeds in the brain and also those with Alzheimer’s-linked gene mutation called APOE4, especially those who have two copies of the mutation. Patients, families along with doctors should consider whether the safety risk outweighs the benefit before starting on Lecanemab.
Aducanumab (Aduhelm™)* Biogen discontinued all sales and research studies of aducanumab on January 31, 2024*
Aducanumab was an anti-amyloid antibody therapy approved for early Alzheimer's disease, including people living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease.
Before starting or stopping medication, please consult with the patient’s health professional. This information is intended to make you aware of potential solutions and challenges with common medications taken for dementia.
Sources: Donanemab for Alzheimer’s Disease, Manly, Deters, JAMA, 2023;330(6):510-511. doi:10.1001/jama.2023.11704; Lecanemab in Early Alzheimer’s Disease, van Dyk CH, Swanson CJ, Aisen P, et al, New England Journal of Medicine 2023; published Jan 5, DOI: 10.1056/NEJMoa2212948
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