FDA approves aducanumab for Alzheimer disease
Aducanumab, an antibody directed against amyloid beta, has been approved by the Food and Drug Administration (FDA) for the treatment of Alzheimer disease (AD).
Patients with mild AD receiving aducanumab showed a significant dose- and time-dependent reduction of amyloid beta plaque in phase 3 trials; patients in the control arm showed no reduction. While a reduction of amyloid beta plaque in the brain, a surrogate endpoint, is reasonably likely to predict a reduction in cognitive decline, the FDA notes that there are residual uncertainties regarding the clinical benefit of aducanumab. The accelerated approval necessitates that post-approval studies are conducted; continued approval is contingent upon verification of clinical benefit in these trials.
Treatment should be initiated only in patients with mild cognitive impairment or mild dementia stage of disease, to reflect the population in the clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of Alzheimer disease.
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Alzheimer disease (AD) is a chronic, progressive neurodegenerative disorder characterized by a global, nonreversible impairment in cerebral functioning.
AD is characterized by memory loss, loss of social and occupational functioning, diminished executive function, speech and motor deficits, personality change, and behavioral and psychological disturbance.
It has a deteriorating course over up to 8-10 years.
Brain lesions are marked by neurofibrillary tangles, senile plaques, neuronal loss, and brain atrophy, with defects in acetylcholine synthesis at the cellular level.
Treatment requires a multidisciplinary approach with increasing emphasis on behavioral and psychological symptoms.
Psychosocial interventions and caregiver support are key to managing disease course. Caregiver support groups are beneficial to caregivers and should be considered, where available.
Alzheimer disease (AD) is a chronic neurodegenerative disease with an insidious onset and progressive but slow decline. AD is the most common type of dementia. It often coexists with other forms of dementia, particularly vascular dementia (mixed-type dementia). The histopathology of AD is characterized by senile plaques, neurofibrillary tangles, and neuronal loss. The hallmark symptoms are memory loss, impairment of daily activities, and neurobehavioral abnormalities. Definition of severity varies according to country, but a commonly accepted categorization is mild, moderate, and severe. The Mini-Mental State Examination can be used as a guide to cognitive impairment, but education, language, and any other relevant factors must be taken into consideration when interpreting scores.
History and exam
- advanced age
- family history
- Down syndrome
- cerebrovascular disease
- lifestyle factors and medications
- less than high school education
- traumatic brain injury
- hearing loss
- female sex
- elevated plasma homocysteine level
- artificially sweetened soft drink consumption
- cerebrospinal fluid (CSF) analysis
- serum rapid plasma reagin/Venereal Disease Research Laboratory (VDRL)
- serum HIV
- formal neuropsychological testing
- genetic testing
- fluorodeoxyglucose-PET (FDG-PET)
- single-photon emission CT (SPECT)
- electroencephalogram (EEG)
Judith Neugroschl, MD
Associate Professor of Psychiatry
Icahn School of Medicine at Mount Sinai
JN declares that she has no competing interests.
Dr Judith Neugroschl would like to gratefully acknowledge Dr Brandy R. Matthews, Dr Asif S. Bhutto, and Dr Julie K. Gammack, the previous contributors to this topic.
BRM, ASB, and JKG declare that they have no competing interests.
Roy J. Goldberg, MD, FACP, AGSF, CMD
Kings Harbor Multicare Center
RJG declares that he has no competing interests.
Philip Scheltens, MD, PhD
Professor of Neurology
Department of Neurology/Alzheimer Center
VU University Medical Center
PS declares that he has no competing interests.
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