Behind the scenes of a 7T MRI clinical study in Alzheimer's disease: challenges and recommendations for future...

Combining pharmacological interventions with neuroimaging in Alzheimer's disease (AD) research presents logistical and methodological challengesparticularly during early study phases, such as recruitment and study visits. Yet, these challenges are rarely reported in detail. This perspective article shares early-phase experiences from a 7-tesla (7T) fMRI clinical study involving individuals with mild cognitive impairment due to AD (MCI-AD) and mild Alzheimer's disease dementia (mild ADD), highlighting recruitment hurdles and offering practical recommendations. From a pool of 1,001 patients, 476 had a clinical diagnosis of MCI-AD or mild ADD; after pre-selection and screening, only 48 participants (10%) met all inclusion criteria. Major exclusion factors included metal or tattoos (8%), missing surgical documentation (2%), beta-blocker use (27.5%), recent cancer/chemotherapy or brain radiation (1%), and lack of interest (20%). Effective communication, often requiring caregiver assistance, was essential for obtaining accurate medical histories and improving adherence. Internally, clear team coordination supported scheduling and protocol compliance. While strict eligibility criteria improve data quality, they can substantially limit recruitment and feasibility in pharmacological and high-field MRI drug studies. We propose strategies to optimize recruitment and screening, facilitate data collection, and balance scientific rigor with real-world clinical feasibility.