- Monoclonal Antibody Therapy (Aduhelm):
In June 2021, the FDA granted approval for Aduhelm (aducanumab) as the first AD treatment to reduce amyloid beta (AB) plaques in the brain. Recent clinical trials showed that Aduhelm reduced AB plaques by 59 to 71% at 18 months of treatment. The drug, jointly produced by Biogen and Eisai, was granted accelerated approval status based on a reduction in AB plaques treated with the drug. It should be noted that continued approval for this indication may be contingent upon verification of clinical benefit in the confirmatory trial(s).
Aduhelm is administered intravenously via a 45-60 minute infusion every four weeks. Typically, the infusion is performed at hospitals or infusion therapy centers. The drug is not a cure for AD or other dementia. However, the FDA indicated that a reduction in AB plaques is reasonably likely to lead to a reduction in the clinical decline due to the disease.
Aduhelm is indicated for treating patients with mild cognitive impairment (MCI) or mild dementia stage of the disease. The drug is intended to allow individuals to actively participate in daily life, have sustained independence, and hold on to memories longer. Moreover, there is no evidence that the drug can restore lost memories or cognitive functions.
Although the FDA did not require testing for AB plaques prior to treatment, physicians should confirm the presence of AB plaques in the brain before prescribing Aduhelm. Therefore, confirmatory tests such as CFS analysis or amyloid PET imaging should be part of the diagnostic process to determine eligibility for treatment.
