Aducanumab: The new medication for treating dementia Health ConditionsHealth ConditionsAlzheimer's & DementiaAnxietyArthritisAsthma & AllergiesBreast CancerCancerCardiovascular HealthCOVID-19Dermatology & SkincareDiabetesEnvironment & SustainabilityExercise & FitnessEye HealthHeadache & MigraineHealth EquityHIV & AIDSHuman BiologyInflammatory Bowel DiseaseLeukemiaLGBTQIA+Men's HealthMental HealthMultiple Sclerosis (MS)NutritionParkinson's DiseasePsoriasisSexual HealthWomen's HealthDiscoverNewsLatest NewsOriginal SeriesMedical MythsHonest NutritionThrough My EyesNew Normal HealthPodcastsHow to understand chronic painWhat is behind vaccine hesitancy?The amazing story of hepatitis C, from discovery to cureNew directions in dementia researchCan psychedelics rewire a depressed, anxious brain?Why climate change matters for human healthToolsGeneral HealthDrugs A-ZHealth HubsHealth ToolsBMI Calculators and ChartsBlood Pressure Chart: Ranges and GuideBreast Cancer: Self-Examination GuideSleep CalculatorHealth ProductsAffordable Therapy OptionsBlood Pressure MonitorsDiabetic SuppliesFitness TrackersHome GymsGreen Cleaning ProductsHow to Shop for CBDQuizzesRA Myths vs FactsType 2 Diabetes: Managing Blood SugarAnkylosing Spondylitis Pain: Fact or FictionConnectAbout Medical News TodayWho We AreOur Editorial ProcessContent IntegrityConscious LanguageNewslettersSign UpFollow UsMedical News TodayHealth ConditionsDiscoverToolsConnectSubscribe What to know about aducanumab — the new medication for dementiaMedically reviewed by Alan Carter, Pharm.D. — By Steph Coelho on August 30, 2022Aducanumab is a newly approved drug for the treatment of mild Alzheimer’s disease. However, there are many risks associated with its use, such as swelling or bleeding. Alzheimer’s disease is a form of dementia. Dementia is an umbrella term to describe a decline in a person’s cognitive abilities. People with dementia may experience a loss in memory, language, problem-solving, and many other thinking abilities. It can affect their ability to perform daily activities. The drug aducanumab received approval from the Food and Drug Administration (FDA) in June 2021 for the treatment of Alzheimer’s disease. However, there has been some controversy over the use of aducanumab for treating Alzheimer’s disease. Many experts have voiced concerns about the drug’s approval — the main concern seems to be that there is not yet enough evidence to support its efficacy in treating the condition. The brand name for aducanumab is Aduhelm. Read on to learn more about aducanumab, including how it works, who is a candidate for treatment, safety considerations, and more. What is aducanumab Share on Pinterestmikroman6/Getty ImagesAducanumab is an FDA-approved monoclonal antibody. Scientists create monoclonal antibodies in a lab. It is a protein that can attach to certain targets in the body. These targets include antigens on the surface of body cells. The FDA approved its use for treating Alzheimer’s disease in June 2021 through its accelerated approval program. This means that aducanumab was approved based on the tests that predict the benefit of the drug. The drug should still undergo further confirmatory trials to ensure it works as intended. The drug does not cure or reverse the progression of dementia in people. How does it work Aducanumab works by reducing the number of amyloid plaques in the brains of people with Alzheimer’s disease. Amyloid plaques are proteins that the body naturally produces. In people with Alzheimer’s, there are more amyloid plaques than usual in the brain. They then clump together and collect between neurons — or nerve cells — disrupting cell communication. Learn more about Alzheimer’s disease here. Who might be eligible for aducanumab Aducanumab is for people with mild cognitive impairment and early or mild Alzheimer’s disease. Experts also recommend prescribing the drug to people with confirmed amyloid deposits and a score of more than 21 in the mini-mental state examination (MMSE) or similar cognitive test. It is not a drug for people with advanced Alzheimer’s disease. Learn more about cognitive tests for diagnosing dementia here. Does it work While there is a link between amyloid plaques and cognitive decline, there is not enough evidence to confirm that reducing them can protect against dementia. Additionally, data from Biogen’s clinical trials before approval have not been published in peer-reviewed journals. Biogen is the company that makes the aducanumab drug. Trials involving other drugs with the same mechanism showed no significant improvement in symptoms. That said, there is promising evidence that aducanumab reduces amyloid plaque deposits. However, there is not enough data to show that this can prevent or treat Alzheimer’s disease. Ultimately, more research would be beneficial. Despite getting accelerated approval from the FDA, Biogen must do a clinical trial to confirm whether the drug is effective. The clinical trial will likely end in 2026. Some experts have concerns regarding the accelerated approval and note that pushing through drugs such as aducanumab may give false hope to those with Alzheimer’s and their loved ones. It is also notable that medical approval bodies such as those in Japan and Europe have not approved the drug. Safety and side effects Another concern regarding aducanumab is its high risk for serious side effects. These can include swelling or bleeding in the brain. Approximately 41% of people in clinical trials for the drug experienced swelling or bleeding. As the drug can cause these serious effects, a doctor will order imaging tests before administering the drug to compare against future imaging. Doctors will order additional imaging 6 and 12 months after starting treatment. Other possible side effects may include:dizzinessheadachesvision disturbancesnauseaconfusiondiarrheaallergic reaction It is important to note that some of the above symptoms may be signs of more serious side effects. How can people access aducanumab Access to aducanumab is still limited. People or loved ones of those with mild Alzheimer’s can ask a doctor whether they are a candidate for aducanumab. Doctors need to confirm the presence of amyloid plaques in the brain before prescribing aducanumab. People may require PET imaging or cerebrospinal fluid analysis to check for these plaques. How is treatment administered Doctors administer aducanumab through a monthly intravenous (IV) infusion. Each infusion lasts about 45–60 minutes every 4 weeks. Treatment can be at the hospital or an infusion therapy center. Cost Aducanumab was initially set at $56,000 USD per year. In 2022, Biogen reduced the price by half. The high cost of the drug is another factor that makes some experts wary of its accelerated approval. If the clinical trial meant to confirm the drug’s efficacy shows it is ineffective, people will have been paying a considerable amount for treatment that does not work. Other treatments for Alzheimer s disease There is no cure for Alzheimer’s disease. However, some drugs may help with mild to moderate symptoms. There are only four other FDA-approved drugs for treating Alzheimer’s disease. These include:donepezil (Aricept)rivastigmine (Exelon)memantine (Nemenda)galantamine (Reminyl) Summary Aducanumab is an FDA-approved drug for the treatment of mild or early onset Alzheimer’s disease. There is much controversy around the accelerated approval of the drug. Experts have flagged concerns over the drug’s high cost and limited evidence regarding its effectiveness. While the drug shows a promising ability to reduce amyloid plaques in the brain, there is not enough evidence to show that this can improve symptoms or prevent disease. More research on the effects of aducanumab and the ability to treat Alzheimer’s disease would be beneficial. Last medically reviewed on August 30, 2022Alzheimer's / DementiaClinical Trials / Drug TrialsNeurology / NeurosciencePharma Industry / Biotech Industry 13 sourcescollapsedMedical News Today has strict sourcing guidelines and draws only from peer-reviewed studies, academic research institutions, and medical journals and associations. We avoid using tertiary references. We link primary sources — including studies, scientific references, and statistics — within each article and also list them in the resources section at the bottom of our articles. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.Accelerated approval program. (2020).https://www.fda.gov/drugs/information-health-care-professionals-drugs/accelerated-approval-programAducanumab approved for treatment of Alzheimer's disease. (n.d.).https://www.alz.org/alzheimers-dementia/treatments/aducanumabControversial Alzheimer's drug approval could affect other diseases. (2021).https://www.nature.com/articles/d41586-021-01763-9Day, G. S., et al. (2022). Aducanumab use in symptomatic Alzheimer disease evidence in focus.https://n.neurology.org/content/98/15/619FDA. FDA grants approval for Alzheimer's drug (2021) [Press release].https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drugMakin, S. (2018). The amyloid hypothesis on trial.https://www.nature.com/articles/d41586-018-05719-4Nothing is right about the approval of aducanumab-and nothing's new. (2021).https://blogs.bmj.com/bmj/2021/11/04/nothing-is-right-about-the-approval-of-aducanumab-and-nothings-new/Padda, I. S., et al. Aducanumab. (2022).https://www.ncbi.nlm.nih.gov/books/NBK573062/Vaz, M., et al. (2022). Role of aducanumab in the treatment of Alzheimer's disease: Challenges and opportunities.https://www.dovepress.com/role-of-aducanumab-in-the-treatment-of-alzheimers-disease-challenges-a-peer-reviewed-fulltext-article-CIAWalsh, S., et al. (2021). Aducanumab for Alzheimer's disease?https://www.bmj.com/content/374/bmj.n1682Cajigal, S. (2021). What FDA's controversial accelerated approval of aducanumab means for other neurology drugs.https://journals.lww.com/neurotodayonline/fulltext/2021/08050/what_fda_s_controversial_accelerated_approval_of.1.aspxWhat happens to the brain in Alzheimer's disease? (2017).https://www.nia.nih.gov/health/what-happens-brain-alzheimers-diseaseWoloshin, S., et al. (2022). What to know about the Alzheimer drug aducanumab (Aduhelm).https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2792897FEEDBACK:Medically reviewed by Alan Carter, Pharm.D. — By Steph Coelho on August 30, 2022 Latest newsWhat sets 'SuperAgers' apart? Their unusually large neuronsOmega-3 may provide a brain boost for people in midlifeSeasonal affective disorder (SAD): How to beat it this fall and winterCDC: Monkeypox in the US 'unlikely to be eliminated in the near future'Why are more women prone to Alzheimer's? New clues arise Related CoverageWhat is dementia (neurocognitive disorder)Medically reviewed by Timothy J. Legg, PhD, PsyD Dementia, now known as major or mild neurocognitive disorder, includes Alzheimer's disease, Parkinson's and other conditions. Find out more.READ MOREIs dementia reversible? The term dementia refers to conditions that affect remembering, thinking, and behavior. Most cases of dementia are not reversible, but there are…READ MORETBI and dementia: Link or no link? Research linking traumatic brain injury and dementia later in life is contradictory. Learn about the latest findings and what they mean for TBI…READ MOREScientists find previously unknown link between metabolism, brain healthREAD MOREWhat to know about dementia and bladder controlMedically reviewed by Shilpa Amin, M.D., CAQ, FAAFP People with dementia can experience difficulties using the bathroom, but behavioral strategies and medications can help. Learn more.READ MORE