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NCT Number: NCT06542458

Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Assessments

Behavioral

Participants will undergo a standard battery of neuropsychological measures, behavioral questionnaire, and functional assessment to monitor cognition and function over time. Clinical data obtained as part of standard of care will be collected from the medical record

Neuroimaging volumetric measures

Other

Neuroimaging volumetric measures will be obtained from already conducted standard of care neuroimaging.

Biofluid samples

Other

Biofluid sampling data will be obtained through another protocol. All participants will be required to sign that consent to participate in this trial.

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Jessica Pommy, PhD

CONTACT

[email protected]

614-293-4969

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Aug 7, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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