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

NCT06542458 — Enrolling by invitation, 100 participants, Ohio State University

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

RegistryNCT06542458
StatusEnrolling by invitation
Study typeObservational
Enrollment100 (Estimated)
SponsorOhio State University (Other)
ConditionsMild Cognitive Impairment, Subjective Cognitive Decline
InterventionsAssessments, Neuroimaging volumetric measures, Biofluid samples (Behavioral, other)
Datesstart 2027-03-01 (estimated), primary completion 2032-01-01 (estimated), completion 2032-01-01 (estimated), first posted 2024-08-07, last updated 2026-10-16
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Mild Cognitive Impairment All trials for Subjective Cognitive Decline All trials of Assessments All trials of Neuroimaging volumetric measures

-Summary

The purpose of this study is to establish a longitudinal cohort of older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI): 1) at heightened risk for dementia, and 2) from underrepresented/under-resourced communities to characterize clinical course. This study will utilize the Tele-Cog clinic as a means for recruiting older adults at risk for dementia from under-resourced and underrepresented communities. Successful completion of this project will increase the opportunity for under-resourced and underrepresented communities to participate in cognitive research.

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+Detailed description

Clinical data obtained as part of standard of care will be collected from the medical record \[including clinical diagnosis, patient history (medical history, problem list, allergies, surgical history, family history, social history, socioeconomic history and social determinants of health), cognitive and other neuropsychological test scores, behavioral questionnaire (such as Neuropsychiatric Inventory), and functional assessment (such as ADL scale and/or Clinical Dementia Rating), lab results, neuroimaging data, etc... For patients who have standard of care neuroimaging data in their medical records we will use this data to obtain neuroimaging volumetric measures. The neuroimaging volumetrics measures, provided by Icometrix, will be research data.

During the research visits participants will undergo a standard battery of neuropsychological measures, behavioral questionnaire and functional assessment to monitor cognition and function over time. The assessments are specific to this research trial and are not administered during the patients routine Tele-Cog clinic visits.

Participants will be asked to participate in annual research visits for up to 5 years.

+Arms and interventions

ArmTypeInterventionsDescription
Study PopulationBehavioral: Assessments; Other: Neuroimaging volumetric measures; Other: Biofluid samplesAdults 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
  • 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.

+Outcome measures

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 [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.

+Eligibility

Sex: All, ages: 50 Years to any

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. The study partner must be ≥18 years of age and must know the patient well enough to contribute information regarding the patient's daily activities and cognition.
7. Must also consent to the Neuroscience Research Institute Brain Bank and Biorepository (NRI-BBB) Banking Protocol (OSU protocol 2020H0512).

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).

+Locations (1)

FacilityCityCountryStatus
The Ohio State UniversityColumbus, OhioUnited States