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Clinical Core

The Clinical Core (CC) performs the essential role of rigorous clinical characterization of study participants to create a common foundation for use by the other Cores and Projects, including baseline assessment of cognitive status and progression over time. It is innovative in its use of both conventional and ambulatory methods to elucidate risk factors and cognitive outcomes in individuals' natural environments. The CC has a strong track-record utilizing multiple modes of data collection, including telephone evaluations, in-person and virtual visits, ambulatory assessments, and at-home surveys to characterize participants.

Overview​

The Clinical Core supports the Einstein Aging Study Program Project (EAS P01) by collecting data for key measures used to characterize the cohort, to define the primary cognitive outcomes for this P01 which include cognitive performance, cognitive decline, mild cognitive decline and dementia. The core also manages the collection of robust data regarding exposures and risk factors to be used by the Projects. These measures cover multiple domains and include objective and subjective assessments collected using both conventional clinic-based and ambulatory methods using smartphones and wearable devices.

This Core has a strong track record utilizing multiple modes of data collection including telephone evaluations, in-person and virtual visits, ambulatory assessments, and at-home surveys to complete annual evaluations. The Clinical Core will:

  1. obtain informed consent;
  2. conduct evaluations that include medical and epidemiologic histories, psychosocial and behavioral reports, annual neurological and neuropsychological evaluations, physical measures (anthropometrics, blood pressure);
  3. obtain fasting blood samples;
  4. train participants in ambulatory and remote data collection techniques;
  5. conduct consensus case conferences to determine clinical cognitive diagnosis (mild cognitive impairment, dementia and dementia subtypes); and
  6. manage participant flow to the Projects and Cores including MRI and consent for brain autopsy.

The CC trains and manages the study staff who conduct these assessments; we have an excellent record of staff retention across many years, who live in the surrounding community and understand the needs and concerns of participants. The Clinical Core cooperates with the Administrative Core to collect follow-up medical and neuropsychological information for study participants no longer able to return for in-person evaluations. Data from the Clinical Core are used to determine participant eligibility for the MRI sub-study. Finally, with the Biomarker Core, the Clinical Core distributes samples to the appropriate labs, and banks biological specimens for current and future assays.

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To read more about the Clincal Core from NIH RePORTER, click here.