Clinical trials for neuropsychiatric syndromes in major and mild neurocognitive disorders: A CONSORT-based approach.

Neuropsychiatric syndromes (NPS) such as agitation, psychosis, apathy, and irritability are among the most disabling features of major and mild neurocognitive disorders including Alzheimer's disease, other neurodegenerative disorders (NDD), and vascular cognitive impairment. Clinical trial methodologies for the treatment of these syndromes are evolving and the first agents to reduce NPS severity has been approved. Biomarkers are rapidly becoming available to guide clinical trial decision-making. Biomarkers can confirm the diagnosis of Alzheimer's disease and are playing a larger role in non-Alzheimer trials. The Consolidated Standards for Reporting Trials (CONSORT) specify the elements of clinical trials that must be reported when clinical trials are published. These criteria provide conventions for uniform reporting of all key aspects of a clinical trial and facilitate comparisons across trials. We describe best practices for clinical trials of NPS including research definitions of the NDD, use of biomarkers to support clinical diagnosis, research criteria for NPS, use of rating scales to define the severity of NPS at baseline and as endpoints for the clinical trial, and approaches to data analysis of specific interest in NPS trials. Standards for describing the limitations of trials and their generalizability are provided. The goal is to inform planning and reporting of NPS trials including the use of biomarkers based on CONSORT guidelines for best trial practices.