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)
| Registry | NCT06542458 |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Ohio State University (Other) |
| Conditions | Mild Cognitive Impairment, Subjective Cognitive Decline |
| Interventions | Assessments, Neuroimaging volumetric measures, Biofluid samples (Behavioral, other) |
| Dates | start 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 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Study Population | Behavioral: Assessments; Other: Neuroimaging volumetric measures; Other: Biofluid samples | 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 |
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).
| Facility | City | Country | Status |
|---|---|---|---|
| The Ohio State University | Columbus, Ohio | United States |