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

NCT06542458 | Not Yet Recruiting

• 1 other identifier: NEW-64541
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Subjective Cognitive Decline

Outcome Measures

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

  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.

  5 years

Study Arms (1)

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

Behavioral: Assessments; Other: Neuroimaging volumetric measures; Other: Biofluid samples

Interventions

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

Study Population

Neuroimaging volumetric measures OTHER

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

Study Population

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.

Study Population

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals will be recruited from the Tele-Cog clinic at The Ohio State University Wexner Medical Center.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jessica Pommy, PhD

CONTACT

614-293-4969; jessica.pommy@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Clinical

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)