Clinical Research Studies

This is a cross-sectional study in 100 older adults (n = 100, 50 female, 60–80 years) who are cognitively normal (n = 70) or have mild cognitive impairment (n = 30). The purpose is to test whether features of body temperature (Tb), measured with ingestible telemetry, are associated with tau pathology, measured with [18-F]-MK-6240 tau PET-MR and plasma P-tau. Participant involvement includes 6 study visits over a period of 4 months. The duration of the project is 5 years. Briefly, subjects who express interest and are eligible for screening based on a pre-screening call will undergo in-person medical screening and complete several intake questionnaires at Visit 1, followed by a blood draw at CTSI, a clinical interview and neuropsychological testing at Visit 2. A 7-day at-home sleep assessment and actigraphy data, after Visit 2, will help us determine sleep-wake cycles and screen for Obstructive Sleep Apnea which is exclusionary for our study, if severe. At Visits 3 & 4, subjects will undergo body temperature measurements with ingestible telemetric thermometry over 48 hours, commencing on Night 1 of a 48 hour visit to the MSCIC sleep lab. Sleep EEG characteristics will be assessed with polysomnography on Nights 1 and 2 of this 48 hour period. During the day between these nights, subjects will be free to return home. After sleep study data is analyzed, the Eligibility Checklist can be completed. At Visit 5 which will take place at least 7 days after the sleep study completion, subjects will undergo a Tau PET/MR scan at the Center for Biomedical Imaging. At Visit 6, at least 7 days after the sleep study (but not on the same day as the Tau PET/MR) subjects will undergo an amyloid PET/MR scan. The purpose of the PET/MR scans is to control for tau and amyloid burden in the central nervous system. This cross-sectional study will lay the ground work for future prospective studies to determine whether Tb based interventions can prevent the progression of NFT pathology toward reducing Alzheimer’s Disease burden.