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Clinical Trials/NCT06542458
NCT06542458
Not yet recruiting
Not Applicable

A Cohort Study of Older Adults From Under-resourced/Under-represented Communities Diagnosed With Subjective Cognitive Decline (SCD) or Mild Cognitive Disorder (MCI) Through Standard of Care Tele-Cog Visits (Tele-Cog)

Ohio State University1 site in 1 country1,000 target enrollmentDecember 1, 2026

Overview

Phase
Not Applicable
Intervention
Assessments
Conditions
Mild Cognitive Impairment
Sponsor
Ohio State University
Enrollment
1000
Locations
1
Primary Endpoint
Number of adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) at risk for dementia from under-resourced/underrepresented communities that we longitudinally collect clinical data, neuropsychology, neuroimaging, and biofluids
Status
Not yet recruiting
Last Updated
2 months ago

Overview

Brief Summary

Overall, this study's primary aim is to establish a prospective, longitudinal, observational cohort study of older adults at risk for dementia from under-resourced/underrepresented communities. More specifically, older adults diagnosed with subjective cognitive decline (SCD) or Mild Cognitive Impairment (MCI) during clinical care offered via the Tele-Cog clinic would be recruited for more comprehensive data collection to characterize the clinical presentation and course of illness over multiple timepoints spread out longitudinally.

Detailed Description

Clinical data obtained as part of standard of care will be collected from the medical record (including clinical diagnosis, cognitive and other neuropsychological test scores, lab results, neuroimaging data, etc.) and additional data (neuropsychological test batteries and clinical questionnaires if not already obtained) would be obtained at research study visits. Participants will be asked to participate in annual research visits for up to 5 years.

Registry
clinicaltrials.gov
Start Date
December 1, 2026
End Date
January 1, 2032
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Douglas Scharre

Professor-Clinical

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • Adults ages 50 years and older
  • Diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up
  • Fluent in English
  • Able to provide voluntary informed consent
  • Willing and able to undergo all study procedures
  • Able to delegate, if possible, a study partner to contribute information regarding daily activities and cognition

Exclusion Criteria

  • Diagnosis of dementia at baseline.
  • Inability to give informed consent.
  • High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).

Arms & Interventions

Study Population

Adults ages 50 years and older who are fluent in English and are diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up

Intervention: Assessments

Study Population

Adults ages 50 years and older who are fluent in English and are diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up

Intervention: Neuroimaging volumetric measures

Study Population

Adults ages 50 years and older who are fluent in English and are diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up

Intervention: Biofluid samples

Outcomes

Primary Outcomes

Number of adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) at risk for dementia from under-resourced/underrepresented communities that we longitudinally collect clinical data, neuropsychology, neuroimaging, and biofluids

Time Frame: 5 years

This study is a longitudinal collection of clinical data, neuroimaging, neuropsychological assessments, and biofluids to establish a cohort of older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) at risk for dementia from under-resourced/underrepresented communities from which hypotheses can be generated. Analysis will also include comparing the subject's longitudinal change over time data. Data will be analyzed with one way and repeated measures (ANOVAs) that will control for important covariates. All imaging data will be analyzed using qualitative visual interpretation and quantitative region of interest approach.

Study Sites (1)

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