Dementia / Alzheimer Disease / Mild Cognitive Impairment · Observational Study

ADRC Clinical Cohort (Alzheimer's Disease)

ClinicalTrials.gov · September 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record for a planned observational cohort study at Duke/UNC ADRC designed to prospectively enroll and follow 500 participants aged 25–80 across normal cognition, mild cognitive impairment, and dementia groups. No results are posted; the record documents study design, planned enrollment targets, and specimen/imaging collection protocol only.

What was studied

Observational. Alzheimer Disease, Mild Cognitive Impairment, Dementia; age from 25 Years; to 80 Years; accepts healthy volunteers. Intervention: Participants aged 25-44; Participants aged 45-80. n = 500. 1 site: United States.

Key findings

Planned enrollment: 500 participants (estimated) Follow-up duration: approximately 5 years for ages 45–80 cohort (yearly visits) Primary outcome measures are enrollment counts by age stratum and cognitive status, not clinical outcomes

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This cohort will support future research on risk factors, biomarkers, and natural history of cognitive aging and dementia; clinicians should note that this registry record itself contains no efficacy, safety, or prognostic results and is intended for hypothesis generation and specimen banking.

Plain-language summary

This is a registry record for an actively recruiting observational cohort study with no posted results; it describes planned enrollment and data collection only.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Number of participants enrolled who are aged 25 to 44 with normal cognition (assessed at Until the end of the study, approximately 5 years); Number of participants enrolled who are aged 45 to 80 with normal cognition (assessed at Until the end of the study, approximately 5 years); Number of participants enrolled who are aged 45 to 80 with mild cognitive impairment (MCI) (assessed at Until the end of the study, approximately 5 years); Number of participants enrolled who are aged 45 to 80 with dementia (assessed at Until the…

DesignObservational

PopulationAlzheimer Disease, Mild Cognitive Impairment, Dementia; age from 25 Years; to 80 Years; accepts healthy volunteers

Sample size500

InterventionParticipants aged 25-44; Participants aged 45-80

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment500

Follow-up durationapproximately 5 years

Age range (younger cohort)25 to 44 years

Age range (older cohort)45 to 80 years

Primary outcome measure 1Number of participants aged 25–44 with normal cognition enrolled

Primary outcome measure 2Number of participants aged 45–80 with normal cognition enrolled

Primary outcome measure 3Number of participants aged 45–80 with mild cognitive impairment enrolled

Primary outcome measure 4Number of participants aged 45–80 with dementia enrolled

Clinical bottom line

Caveats

No results posted; this is a protocol registration only
Primary outcomes are enrollment counts, not clinical or cognitive endpoints
Recruitment status is active; no completion data or follow-up findings available
No detail on recruitment strategy, eligibility criteria beyond age and cognition status, retention rate, or statistical analysis plan

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational prospective cohort with structured baseline and longitudinal follow-up.

Directness

moderate

Aims to study natural history of cognition and dementia; outcomes are enrollment counts and descriptive, not clinical.

Consistency

insufficient

Registry record only; no results posted or compared to other cohorts.

Risk of bias

insufficient

No methods detail on recruitment, exclusion criteria, retention strategy, or analytical plan provided.

Sample adequacy

moderate

Planned enrollment 500 across multiple age and cognition strata over ~5 years follow-up.

Source abstract

Registry record from ClinicalTrials.gov (NCT06703541). This is a study registration, not published results. Lead sponsor: Duke University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Alzheimer Disease, Mild Cognitive Impairment, Dementia. Primary outcome measures: Number of participants enrolled who are aged 25 to 44 with normal cognition , Until the end of the study, approximately 5 years; Number of participants enrolled who are aged 45 to 80 with normal cognition , Until the end of the study, approximately 5 years; Number of participants enrolled who are aged 45 to 80 with mild cognitive impairment (MCI) , Until the end of the study, approximately 5 years; Number of participants enrolled who are aged 45 to 80 with dementia , Until the end of the study, approximately 5 years. Brief summary: The purpose of the study is to establish a clinical cohort for the Duke/UNC Alzheimer's Disease Research Center (ADRC). The cohort will be composed of subjects ages 25 to 44 at enrollment with normal cognition and subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or a dementia diagnosis. Initial data including demographics, medical and family history, physical exam, and neuropsychological testing will be obtained. Participants will be asked to contribute a blood sample, a urine sample, a cerebrospinal fluid sample, and undergo a MRI scan. The cohort ages 45 to 80 will be seen yearly until death to evaluate medical status, undergo neuropsychological testing and possibly collect additional samples or undergo additional imaging. All data will be de-identified and stored by the ADRC. The purpose of this study is to examine normal cognition, mild cognitive impairment and Alzheimer's disease and related dementias (ADRD) as people get older. The investigators also hope to be able to assess risk factor information of the role of genes and environmental exposures (for example health conditions, diet, and medications) in Alzheimer's disease and related disorders (ADRD) and other conditions of aging. The biological samples collected in the study will create a repository. A repository is a collection of blood and tissue samples from people with certain diseases and conditions. For the purpose of this research, the investigators hope to help researchers learn more about Alzheimer's disease and related disorders and other conditions of aging.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

DementiaAlzheimer DiseaseNCT06703541Duke UniversityMild Cognitive Impairment