Public Health.

Background: Alzheimer's Disease and Related Dementias (ADRDs) patients have a well-established increase in comorbid disorders compared to non-cognitively impaired aged-matched controls. Since ADRDs are considered age-related disorders, it was hypothesized that younger ADRD patients should have a lower incidence of comorbid disorders than older ADRD patients.

Method: Four patient cohorts were defined in the TriNetX Analytics Network database (comprised of anonymized healthcare records from >150 million patients who have received care at 80+ health care organizations in the United States).

Demographic comparison of subjects in FDA approval trials in the United States to disorder specific demographics using Real World Data.

The Food and Drug Administration (FDA) has recommended that clinical trial study populations accurately reflect the patients likely to use the product, if approved. The FDA has not provided specific guidance on how cohort sizes of clinically relevant demographic characteristics should be determined. Therefore, the present study was designed to compare demographic characteristics reported in US-only FDA approval trials to the demographic characteristics of the related medical disorders in an electronic health records database of >150 M patients in the United States (US).

Real world data analysis of frontotemporal dementia: Implications for future clinical research.

Frontotemporal dementia (FTD) is a progressive decline of cognitive abilities associated with other neuropsychiatric comorbidities. A real-world data (RWD) analysis of a large electronic healthcare records (EHR) database identified the comorbidities of FTD. Deidentified EHRs in the TriNetX Network database from >155,000,000 individuals in the United States established an FTD Cohort (ICD-10 Code G31.

Demographic Analysis of Industry-Sponsored Alzheimer's Disease Trial Populations in the United States.

The Food and Drug Administration has that "sponsors should enroll participants who reflect the characteristics of clinically relevant populations". Recent reports have noted that global Alzheimer's Disease trials have enrolled predominantly White subjects. However, a thorough analysis of industry-sponsored, United States-only Alzheimer's trials has yet to be performed.

Defining demographic cohorts in clinical trial populations using large electronic health records databases.

The Food and Drug Administration (FDA) has stressed the need to ensure that clinical trial study populations accurately reflect the patients likely to use the product, if approved. However, the FDA has not provided specific guidance on how clinically relevant demographic characteristics might be defined. Therefore, the present study was designed to develop a framework that could be used to rapidly identify population demographics for any medical condition.