Learn More: What You Should Know About Aducanumab

Alzheimer’s disease is a brain disorder that destroys memory and thinking skills over time. It is the most common form of dementia in older adults. Today, some 5.3 million Americans live with Alzheimer’s disease, and it is now the sixth leading cause of death in the United States. The number of older adults who will develop Alzheimer’s disease is expected to more than triple by 2050.

The exact causes of Alzheimer’s disease are not fully known, but some risk factors are recognized. Aging is the most important one.  Others include genetics – you may be more likely to develop Alzheimer’s disease if a family member was affected. Scientists are studying the relationship between problems with memory and thinking and other conditions such as high blood pressure, heart disease, stroke, and diabetes. Researchers have also been investigating how factors such as education, diet, and environment may play a role.

Like other chronic diseases, Alzheimer's has no cure.  But much can be done to help people living with the disease and the family and friends who care for them.  Some medications, such as donepezil (Aricept), galantamine (Razadyne) and rivastigmine (Exelon), can improve some symptoms.  Other medications may help some individuals with Alzheimer's disease who are experiencing severe depression, anxiety, or changes in behavior.  There are also many supportive services that can be provided to patients and their families to make living with Alzheimer's disease much easier.  These include counseling and education, planned social activities, and taking breaks, among others. 

A great deal of research has been focused on discovering new medical treatments for Alzheimer's disease. In June 2021, the Food and Drug Administration (FDA) approved a drug called aducanumab (Aduhelm™). In July, the FDA narrowed aducanumab’s approval to treating patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. People with more advanced stages of dementia are not eligible for this treatment. 

The FDA used a special type of evaluation in its decision, called an 'accelerated approval pathway.'  This allows patients with serious or life-threatening diseases access to a drug if there is hope of improvement—even if there is still uncertainty about the drug’s benefits to patients. Accelerated approval can be granted when a drug affects a “surrogate endpoint.” This means that a drug can get approval if it improves something that could eventually lead to patient benefit, but it isn't the same thing as directly leading to benefits.

In Alzheimer’s disease, the surrogate endpoint considered by the FDA is the removal of a protein called amyloid from the brain.  Abnormal amyloid build-up is considered a "marker" of Alzheimer's disease.  We do not yet know if reducing amyloid in the brain will benefit patients either by reducing Alzheimer’s disease symptoms or by helping to sustain brain function over time.

Because it's uncertain whether or how much aducanumab might help patients, the FDA is requiring Biogen, its manufacturer, to do an additional clinical trial. This study is currently being designed, and is intended to see whether aducanumab slows the progression of Alzheimer’s disease when are measured by direct benefits to patients, not just by changes in a surrogate endpoint (brain amyloid deposits). Biogen has indicated that the study could take up to nine years to produce results.

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Last Updated August 2022

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