When will the FDA approve the first disease-modifying treatment for Alzheimer's disease?

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Main topic: Science
Other topics: Health, Alzheimer's, FDA
Short answer: FDA approved the use of Aducanumab on 7 June 2021. It is the first Alzheimer's disease-modifying drug. However, its efficacy has been the subject of great controversy.

Alzheimer's is classified as a progressive brain and neurological disorder that results in atrophy of the brain and death of brain cells. It happens due to the accumulation of β-amyloid peptides on neurons.[1]

Brain Inflammation from Alzheimer's Disease. Image Credit:NIH Image Gallery

Alzheimer's is difficult to diagnose and treat[edit]

Finding a treatment for neurodegenerative disorders such as Alzheimer's is difficult. The blood-brain barrier separates the brain's blood supply from the rest of the body. Hence, it's difficult for medications to enter the brain, and the diagnosis is difficult too. Proposed drugs have a 99.6% failure rate.[2]

Many pharmaceutical companies have quit the research due to expensive failures[edit]

Several pharmaceutical companies have quit their research into finding a cure for Alzheimer's as a lack of early diagnosis results in expensive and complex clinical trials. The pharmaceutical giant Pfizer stated that it would cease research into creating medications to treat Alzheimer's disease after a decade of costly failures.[3]

Majority of current medications have been treating the symptoms[edit]

Most Alzheimer's treatments aim to improve the quality of affected people. These medications include cholinesterase inhibitors to improve cholinergic transmissions in the basal brain, which are involved earlier in disease progression,[4] and N-methyl-D-aspartate antagonists for slowing down neuron damage.[5]

FDA has approved the first Alzheimer's disease-modifying treatment[edit]

FDA approved the use of one Alzheimer's disease-modifying drug called Aducanumab on 7 June 2021. It is the first approved disease-modifying drug for the treatment of Alzheimer's. Aducanumab is essentially immunotherapy with specialized antibodies that break down the protein beta-amyloid reducing the brain lesions called amyloid plaques.[6] The efficacy of this drug has been subject of great controversy.[7]

Future treatments for Alzheimer's are under clinical trials[edit]

Several Anti-amyloid aggregation medications, β-secretase, and γ-secretase inhibitors, immunotherapy, monoclonal antibody treatments, and Copper & Zinc modification drugs are under work. They are in various stages of clinical trials with mostly positive results.[8]


  1. Murphy, M. Paul; LeVine, Harry (2010-1). "Alzheimer's Disease and the β-Amyloid Peptide". Journal of Alzheimer's disease : JAD. 19 (1): 311. doi:10.3233/JAD-2010-1221. ISSN 1387-2877. PMC 2813509. PMID 20061647. Check date values in: |date= (help)
  2. World, Maria Burke,Chemistry. "Why Alzheimer's Drugs Keep Failing". Scientific American. Retrieved 2022-10-13.
  3. "Pharma giant Pfizer pulls out of research into Alzheimer's". BBC News. 2018-01-10. Retrieved 2022-10-13.
  4. Singh, Ravneet; Sadiq, Nazia M. (2022), "Cholinesterase Inhibitors", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 31335056, retrieved 2022-10-13
  5. Smith, Matt. "NMDA receptor antagonists and Alzheimer's". WebMD. Retrieved 2022-10-13.
  6. Research, Center for Drug Evaluation and (2021-06-07). "FDA's Decision to Approve New Treatment for Alzheimer's Disease". FDA.
  7. Tampi, Rajesh R; Forester, Brent P; Agronin, Marc (2021-10-04). "Aducanumab: evidence from clinical trial data and controversies". Drugs in Context. 10: 2021–7–3. doi:10.7573/dic.2021-7-3. ISSN 1745-1981. PMC 8491638 Check |pmc= value (help). PMID 34650610 Check |pmid= value (help).
  8. Yiannopoulou, Konstantina G.; Papageorgiou, Sokratis G. (2013-1). "Current and future treatments for Alzheimer's disease". Therapeutic Advances in Neurological Disorders. 6 (1): 19–33. doi:10.1177/1756285612461679. ISSN 1756-2856. PMC 3526946. PMID 23277790. Check date values in: |date= (help)