Stanford Alzheimer's Disease Research Center
To our Stanford ADRC participants concerning Aducanumab
Aducanumab approved by the FDA
Aducanumab received accelerated approval by the FDA on June 7, 2021, for the treatment of Alzheimer’s disease. This drug is a monoclonal antibody directed against amyloid, and it is administered as an intravenous infusion every 4 weeks. “Accelerated approval” differs from regular FDA approval. Accelerated approval can be based on a substitute endpoint — in this case, brain amyloid visualized with a PET brain scan — and accelerated approval does not require demonstration that the drug is clinically effective. Rather, accelerated approval reflected the view that there is an important unmet medical need when it comes to the treatment of Alzheimer’s disease and the drug has an effect on brain amyloid.
The accelerated approval of aducanumab followed on the heels of two, very large clinical trials (phase-3 trials), each lasting one and a half years. Both trials involved people with very mild forms of Alzheimer’s disease. The trials did not include people with moderate or severe dementia.
It is clear that aducanumab reduces amyloid plaque in the brain. Other monoclonal antibody treatments also reduce brain amyloid but failed to provide clinical benefit and failed to gain FDA approval. We are concerned that the average clinical effect of aducanumab in the first phase-3 clinical trial was too small to be noticed by patients or family members. Results from the second phase-3 trial failed to detect even this very small effect.
The principal side effect in these trials was ARIA (Amyloid-Related Imaging Abnormalities). ARIA represents swelling or bleeding in the brain, as detected by an MRI brain scan. This side effect is usually not serious (although it can be), and ARIA can be associated with headache and confusion. Some Alzheimer’s disease specialists are concerned by a treatment that has not shown clinically meaningful benefit and is associated a degree of potential harm.
This drug is not yet available at Stanford Health Care but will be soon. The Centers for Medicare and Medicaid Services (CMS) is considering whether Medicare, the primary insurer for most Americans aged 65 and over, will cover Medicare Part B prescriptions for aducanumab. It has not yet made this determination. We will provide updated information as it becomes available.
We continue the search for better, more effective means of prevention and treatment through NIH-sponsored research in the Stanford Alzheimer’s Disease Research Center. It remains to be seen whether aducanumab is a helpful step along this arduous pathway. Further information on the aducanumab clinical trials is provided in the report of the Institute for Clinical and Economic Review (ICER) and its summary document.
Stanford Alzheimer's Disease Research Center (ADRC)
The Stanford Alzheimer’s Disease Research Center (ADRC) is part of a nationwide network of congressionally mandated Centers of Excellence supported by the National Institutes of Health. The Centers of Excellence programs help establish critical research infrastructure; foster collaboration; train researchers, physician scientists, and other professional staff; and provide shared resources through core facilities.
Thirty-one Alzheimer’s Disease Research Centers at major universities work together to translate research advances into improved diagnosis and care for people with Alzheimer’s disease and related disorders. The ultimate goals are to cure Alzheimer’s disease and, even more important, to prevent it from developing.
The clinical and research focus of the Stanford ADRC includes both Alzheimer’s disease and the spectrum of Lewy body disorders, the two most common causes of neurodegeneration. We believe that research and patient care can be advanced by comparing and contrasting distinctive features of each. We follow volunteers with Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease, and mild cognitive impairment, and we follow healthy older adults without cognitive impairment. Our outreach activities include Latinx and Asian communities in the Bay Area.
Stanford ADRC partners include the National Alzheimer’s Coordinating Center, the National Centralized Repository for Alzheimer’s Disease and Related Dementias, the National Institute on Aging Genetics of Alzheimer’s Disease Data Storage Site, the Resource Centers for Minority Aging Research, the Alzheimer’s Clinical Trials Consortium, and the Alzheimer’s Disease Cooperative Study. Local partners include Stanford Medicine, the VA Palo Alto Health Care System, the Northern California and Northern Nevada chapter of the Alzheimer’s Association, the Pacific Udall Center, the Stanford Neurosciences Institute, and the Stanford Lewy Body Dementia Research Center of Excellence.
- APDA Info & Referral Center at Stanford
- Neuroscience Supportive Care Program
- Pacific Udall Center
- Stanford Aging Adult Services
- Stanford Center on Longevity
- Stanford Lewy Body Dementia Research Center of Excellence
- Stanford Memory Disorders Center
- Stanford Movement Disorders Center
- Stanford Neurosciences Institute
- Stanford School of Medicine
To our Stanford ADRC participants concerning the COVID-19 pandemic
Stanford Alzheimer’s Disease Research Center
213 Quarry Road
Palo Alto, CA 94305
Tel (650) 721-2409
Fax (650) 723-7434
Christina Wyss-Coray, RN