FDA issues guidance on development for early Alzheimer’s disease drugs

On Monday, the US Food and Drug Administration (FDA) issued a revised draft guidance,  Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry.

Once finalized, the guidance will provide recommendations to help drug companies developing medicines to treat patients with early stages of Alzheimer’s disease that occur before the onset of overt dementia.

Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain - including the formation of amyloid beta plaques and neurofibrillary, or tau, tangles - that result in loss of neurons and their connections.