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Not yet recruitingNCT06542458Updated Feb 25, 2026

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

An observational study in Mild Cognitive Impairment and Subjective Cognitive Decline, sponsored by Ohio State University. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mild Cognitive Impairment
  • Subjective Cognitive Decline
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of dementia at baseline.
  2. Inability to give informed consent.
  3. 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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • BehavioralAssessments

    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

  • OtherNeuroimaging volumetric measures

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

  • OtherBiofluid samples

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

06

What researchers measure

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.

    Time frame: 5 years

07

Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06542458
Lead sponsor
Ohio State University
Responsible party
Douglas Scharre (Professor-Clinical, Ohio State University) — Principal investigator
First posted
Aug 7, 2024
Start date
Dec 1, 2026 (estimated)
Primary completion
Jan 1, 2032 (estimated)
Completion
Jan 1, 2032 (estimated)
Last update
Feb 25, 2026

Study contacts

Jessica Pommy, PhD
Contact
jessica.pommy@osumc.edu
614-293-4969

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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