Treatment for Alzheimer's
Although a cure does not exist for Alzheimer's, treatment options continue to improve as we learn more about this disease and the science behind it.
Aducanumab (under the brand name AduhelmTM), a monoclonal antibody from Biogen, was approved by the U.S. Food and Drug Administration (FDA) in June 2021 as a therapy for Alzheimer's disease. In clinical trials, aducanumab was shown to reduce amyloid plaque in the brain. It is the first therapy that may delay decline in people living with Alzheimer’s. Aducanumab has been tested in patients with Mild Cognitive Impairment--people with memory loss on cognitive testing but still able to function well in their daily activities--and those with early stage Alzheimer's disease.
Aducanumab was approved using the FDA's Accelerated Approval pathway. Its manufacturer, Biogen, is ramping up large-scale production for nationwide distribution. The FDA has also ordered Biogen to conduct another study related to the effectiveness of this drug.
How It Works
Aducanumab targets the build up of amyloid plaques in a the brain, a defining feature of Alzheimer's. In clinical trials, the drug was shown to reduce amyloid in the brain by sending a signal to the body's immune system to clear the plaques. It remains unclear whether removal of the plaque will ultimately benefit the cognitive function of the patient.
Approval of this therapy reinforces the importance of early detection and diagnosis to ensure individuals receive the most benefit as soon as possible.
Frequently Asked Questions
Individuals diagnosed with mild Alzheimer’s disease confirmed by objective tests of cognitive function and other tests such as an amyloid PET scan or spinal tap for biomarkers could be candidates for the drug.
If you think you qualify, talk with your primary care provider or call the Hanshaw Geriatric Center at Marshall Health at 304-691-1010.
Aducanumab is administered intravenously (IV) via a 45- to 60-minute infusion every four weeks and at least 21 days apart. Infusion can be done at hospitals or infusion therapy centers, and can even be administered at a person’s home by specialized nurses.
Ongoing monitoring for Amyloid Related Imaging Abnormalities (ARIA) is also required throughout treatment. An initial brain magnetic resonance imaging (MRI) must be obtained within one year prior to initiating treatment. Additional MRIs are taken prior to the seventh and 12th infusion.
In clinical trials, the most common side effects were abnormal brain changes associated with anti-amyloid treatments — most often swelling in the brain — that are spotted with ongoing neuroimaging techniques like MRI; headache; micro hemorrhage/superficial siderosis; and fall.
We do not know if people taking blood thinning medication are at increased risk of ARIA-H (micro bleeds in the brain), as people on these medications were excluded from the studies.
Insurers, including Medicare, are still deciding whether to cover aducanumab.
Accelerated approval by the U.S. Food & Drug Administration (FDA) allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
Learn about the FDA's Accelerated Approval Program.
We encourage patients and family members to learn as much as they can about this new treatment option and discuss it with your doctor.
Additional resources include:
ClinicalTrials.gov. 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE). Available at: https://clinicaltrials.gov/ct2/show/NCT02477800?term=aducanumab&draw=2. Accessed February 1, 2020.
ClinicalTrials.gov. 221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (EMERGE). Available at: https://clinicaltrials.gov/ct2/show/NCT02484547?term=aducanumab&draw=2. Accessed February 1, 2020.
Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement 2011; 7(3):270-279.
McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement 2011; 7(3):263-269.
If you or a loved one is experiencing new and progressive concerns with memory, language or behavior, the first best step is to consult with a doctor. Start with your primary care physician and consider requesting a referral to one of our geriatric specialists.