Aducanumab

Key Points

  • Aducanumab is an experimental drug currently being investigated in patients with the mildest symptoms of Alzheimer’s disease.
  • Aducanumab is currently not approved for clinical use in Alzheimer’s disease and cannot currently be prescribed by your doctor.
  • Right now, the Food and Drug Administration (FDA) is actively reviewing information from recent clinical therapeutic trials to determine if Aducanumab might be helpful for the treatment of Alzheimer’s disease.
  • We do not know if the FDA will approve Aducanumab for clinic use in Alzheimer’s disease, and access to Aducanumab at UCSF will depend on the FDA’s decision.
  • If you or your loved one is worried about new progressive concerns with memory, language, or behavior, the best first steps are to consult with your doctor and consider a referral to a neurologist.
  • If you are interested in participating in a UCSF research study of a different experimental therapy (other than Aducanumab), more information can be found in the Clinical Trials Program pages.

About Alzheimer’s Disease

Alzheimer’s disease is one of many causes of dementia. Alzheimer’s disease involves two proteins, amyloid beta and tau. These proteins abnormally collect in the brain many years before a person develops symptoms and typically cause mild Alzheimer’s disease symptoms for several years before more the disabling symptoms of Alzheimer’s dementia occur. So far, the Food and Drug Administration (FDA) has not found any drugs to be effective in removing abnormal brain proteins or slowing disease progression in people with Alzheimer’s disease.

About Aducanumab

Aducanumab is an experimental drug designed to use antibodies (immune proteins) to remove abnormal amyloid beta proteins from the brain in people with Alzheimer’s disease. We do not know if the FDA will approve Aducanumab for clinic use in Alzheimer’s disease and access to Aducanumab at UCSF will depend on the FDA’s decision. So far Aducanumab has been investigated in multiple clinical trials, including two large Phase 3 trials (EMERGE and ENGAGE) in people with early symptoms from Alzheimer’s disease. Based on the combined results of these trials, dementia experts have so far expressed conflicting opinions (some skeptical and some positive) about Aducanumab’s potential in the treatment of Alzheimer’s disease. On November 6, 2020, the FDA convened a panel of experts from outside of the FDA, and this panel did not recommend approving Aducanumab for clinical use. While the FDA will seriously consider this panel’s opinion, scientists in the FDA will continue carefully reviewing all available clinical trial data and make their own decisions about whether Aducanumab is appropriate for use in Alzheimer’s disease treatment or if more clinical trials are needed. 

So far, Aducanumab has been best studied in patients with the very early symptoms of Alzheimer’s disease with objective evidence of brain amyloid beta collection using a special brain scan called an amyloid positron emission tomography (PET) scan. It is possible that these previous clinical trial details might impact the FDA’s specific recommendations for Aducanumab use if this medication is approved.

Aducanumab’s FDA Timeline

  • July 8, 2020: The owners of Aducanumab submitted an application to the FDA to license the use of Aducanumab in Alzheimer’s disease.
  • August 7, 2020: The FDA agreed to begin a review of Aducanumab’s potential use for Alzheimer’s disease.
  • November 6, 2020: Timing of the FDA expert panel review of Aducanumab.
  • March 7, 2021: Aducanumab Prescription Drug User Fee Act action date for Aducanumab – The FDA will most likely make a decision about Aducanumab by this date, though it is possible they will make a decision much sooner under their expedited review process.

Potential Risks of Aducanumab

A large minority of patients who receive Aducanumab develop a kind of brain inflammation called amyloid-related imaging abnormalities (ARIA). People who carry a specific gene version called ApoE4 are particularly susceptible to developing ARIA. While most ARIA is mild, serious symptoms and complications do very rarely occur. The occurrence of ARIA will likely have an impact on the FDA’s specific safety recommendations if Aducanumab is clinically approved.

What Can You Do in the Near Future?

Most importantly, if you or your loved one is worried about new and progressive concerns with memory, language or behavior, you should consult with a doctor and specifically consider a referral to a neurologist. The UCSF Memory and Aging Center Clinic is one possible option for patients seeking a neurological assessment for their memory, language, or behavior concerns. Your neurologist should be the best resource for helping you to navigate any tests or medications that might be right for your current care. We don’t know if Aducanumab will be approved for clinical use, so Aducanumab should not currently impact your medical plan of care or impact your enrollment in any current clinical research projects. If the FDA approves Aducanumab for clinical use and your neurologist thinks you may have early Alzheimer’s disease symptoms, you may consult with your neurologist about whether or not this medication is right for you. For patients who have already established care in the Memory and Aging Center Clinic, we will be working closely with your UCSF neurologist to carefully establish guidelines and methods for access to Aducanumab at UCSF in the event that it is approved for clinical use by the FDA.

The UCSF Memory and Aging Center has ongoing research studies of other investigational agents for Alzheimer’s disease and other forms of dementia. If you are interested in participating in a research study of a different experimental therapy (other than Aducanumab), contact the Clinical Trials Program.