Asymptomatic People Should Be Included in Alzheimer’s Trials, Draft Guidance Says

Drugs for cognitively and functionally normal people who have the pathophysiologic changes of Alzheimer’s disease (AD) could be approved on a single biomarker outcome, according to the FDA’s new draft guidance on drug development for early AD.

These people, defined in the draft as patients with Stage 1 disease, are an important population for Alzheimer’s clinical trials because early intervention might alter disease progression, the draft says.

“Because it is highly desirable to intervene as early as possible in AD, it follows that patients with characteristic pathophysiologic changes of AD but no subjective complaint, functional impairment, or detectable abnormalities on sensitive neuropsychological measures” (Stage 1 AD patients) are an important target population for enrollment in clinical trials, the guidance says.

Read the draft guidance here.

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