Mild Cognitive ImpairmentNCT06542458
Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog
An observational study of Mild Cognitive Impairment and Subjective Cognitive Decline, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Subjective Cognitive Decline
- What is being tested?
- Assessments, Neuroimaging volumetric measures and Biofluid samples
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 1 Jan 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals will be recruited from the Tele-Cog clinic at The Ohio State University Wexner Medical Center.
Who may be able to join
- 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. 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.
- Must also consent to the Neuroscience Research Institute Brain Bank and Biorepository (NRI-BBB) Banking Protocol (OSU protocol 2020H0512).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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.
Read the 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.
- Being tested
- Assessments, Neuroimaging volumetric measures, Biofluid samples
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentsBehavioural
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 measuresOther
Neuroimaging volumetric measures will be obtained from already conducted standard of care neuroimaging.
Biofluid samplesOther
Biofluid sampling data will be obtained through another protocol. All participants will be required to sign that consent to participate in this trial.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Assessments; Other: Neuroimaging volumetric measures; Other: Biofluid samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Scharre, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542458
- Sponsor's protocol ID
- STUDY20251447
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06542458
- Acronym / sponsor ID
- STUDY20251447
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Behavioral: 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals will be recruited from the Tele-Cog clinic at The Ohio State University Wexner Medical Center.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentsParticipants 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 | Behavioural | Study Population |
| Neuroimaging volumetric measuresNeuroimaging volumetric measures will be obtained from already conducted standard of care neuroimaging. | Other | Study Population |
| Biofluid samplesBiofluid sampling data will be obtained through another protocol. All participants will be required to sign that consent to participate in this trial. | Other | Study Population |
Primary outcome
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Subjective Cognitive Decline, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.