Conducting MRI trials in Alzheimer's patients: Challenges and Guidelines.

Abstract

Combining pharmaceutical interventions with neuroimaging in Alzheimer's disease (AD) research presents logistical and methodological challenges. This perspective paper outlines early-phase experiences from a 7-tesla (7T) fMRI clinical trial involving individuals with mild cognitive impairment (MCI) and mild AD, highlighting recruitment hurdles and practical recommendations. From a pool of 1,000 patients, 475 had MCI or AD clinically diagnosed; following pre-selection and screening, only 6% met all inclusion criteria. Major barriers included exclusion due to comorbidities, difficulties with blood draws, miscommunication about study procedures, and unreported medical conditions discovered during MRI. Effective communication, often requiring caregiver involvement, was essential for obtaining accurate medical histories and improving adherence. Internally, clear team coordination helped manage scheduling and protocol compliance. While strict eligibility criteria enhance data quality, they significantly impede recruitment and feasibility in high-field MRI drug studies. We offer recommendations to optimize recruitment and screening, improve protocol execution, and better balance scientific rigor with real-world clinical constraints.