Biomarker-only diagnosis of Alzheimer's disease: Not ready for prime time.

Abstract

The Alzheimer's Association Workgroup research criteria for diagnosis and staging of Alzheimer's disease hypothesize diagnostic meaning in the absence of clinical symptoms. If operationalized, this would trivialize neuropsychological assessment but would also expand the pool of candidates for anti-amyloid therapies. A recent survey of the reactions of clinical neuropsychologists to these criteria suggested that the purpose lacked clarity, among other concerns. Given the current landscape in Alzheimer's disease therapeutics, with substantial toxicity and unclear benefit, as well as the poorly understood relationships between biomarkers and clinical signs at the individual level, the roll out of biomarker-only disease seems premature.