Open AccessOn the design of early-phase Alzheimer’s disease clinical trials with cerebrospinal fluid tau outcomes
Author(s) -
Michelle M. Nuño,
Joshua D. Grill,
Daniel L. Gillen
Publication year - 2021
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/17407745211034497
Subject(s) - biomarker , dementia , disease , oncology , clinical trial , alzheimer's disease neuroimaging initiative , population , alzheimer's disease , medicine , psychology , biology , biochemistry , environmental health
The focus of Alzheimer's disease studies has shifted to earlier disease stages, including mild cognitive impairment. Biomarker inclusion criteria are often incorporated into mild cognitive impairment clinical trials to identify individuals with "prodromal Alzheimer's disease" to ensure appropriate drug targets and enrich for participants likely to develop Alzheimer's disease dementia. The use of these eligibility criteria may affect study power.