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

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)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06542458
Enrollment
1000
Registered
2024-08-07
Start date
2026-12-01
Completion date
2032-01-01
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Subjective Cognitive Decline

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.

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.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

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).

Design outcomes

Primary

MeasureTime frameDescription
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 biofluids5 yearsThis 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.

Countries

United States

Contacts

CONTACTJessica Pommy, PhD
jessica.pommy@osumc.edu614-293-4969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026