Duke/UNC Alzheimer's Disease Research Center (ADRC) Clinical Cohort

This observational study aims to create a group of people (a clinical cohort) for the Duke/UNC Alzheimer's Disease Research Center. Researchers are looking for 500 participants aged 25 to 80, including those with normal memory and thinking, mild cognitive impairment (MCI), or a diagnosis of dementia. The study is not testing a specific treatment, but rather collecting information like medical history, physical exams, memory tests, and samples (blood, urine, spinal fluid, and MRI scans). The goal is to better understand neurodegenerative brain disorders like Alzheimer's disease. The study is currently recruiting participants.

Study design
This is an observational study aiming to enroll 500 participants. It is not testing a specific intervention.
What's involved
You would provide initial data including medical and family history, have a physical exam, undergo neuropsychological testing, and provide blood, urine, and cerebrospinal fluid samples, and an MRI scan. If you are aged 45-80, you would be seen yearly until death for medical status updates and neuropsychological testing, and possibly provide additional samples or imaging.
Compensation
Not stated in the trial record.
Follow-up
Participants aged 45 to 80 will be seen yearly until death. The primary endpoints are measured until the end of the study, approximately 5 years.

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NCT06703541

ADRC Clinical Cohort (Alzheimer's Disease)

Recruiting
Not specifiedAges 25–80Observational
Duke University
~500 participants
Updated 2025-08-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants enrolled who are aged 25 to 44 with normal cognition
Measured over Until the end of the study, approximately 5 years
+3 more outcomes measured
Alzheimer Disease
Mild Cognitive Impairment
Dementia
1 sites across 1 states
North Carolina1
  • Heather E Whitson, MD, MHS · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

Each subject must be ≥ 25 to ≤ 80 years of age.
Each subject must be able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude intellectual disability.
Each subject (or legal representative) must sign the informed consent form after the scope and nature of the investigation have been explained to them, and before screening assessments. Some consent may be obtained via phone script and REDCap eConsent.
Each participant must be willing to have an MRI and a lumbar puncture, or alternately (to the lumbar puncture) a series of PET scans.
Each participant ages 45 to 80 must have a study partner who agrees to participate in the study and who is able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude intellectual disability.

Exclusion

Evidence of a clinically relevant or unstable neurological disorder including history of multiple head injuries, stroke or other CNS conditions (MS, Parkinson's disease, etc.)
Evidence of a clinically relevant or unstable psychiatric disorder.
History of alcoholism or drug dependency/abuse within the last 2 years before enrollment.
GAD-7 score \>9 and/or PHQ-8 score \>9
An ongoing uncontrolled, clinically significant medical condition such that, in the judgment of the investigator, a subject's participation in the trial would pose a significant medical risk to the subject.
Contraindication or intolerance to 3T MRI investigations, including implanted devices
History of malignancy of any organ system, treated or untreated, within the past 60 months, regardless of whether there is evidence of local recurrence or metastases. However localized nonmalignant tumors not requiring systemic chemo- or radiotherapy, localized basal or squamous cell carcinoma of the skin, or in-situ cervical cancer are permitted.
  • Number of participants enrolled who are aged 25 to 44 with normal cognitionUntil the end of the study, approximately 5 years

    The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.

  • Number of participants enrolled who are aged 45 to 80 with normal cognitionUntil the end of the study, approximately 5 years

    The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.

  • Number of participants enrolled who are aged 45 to 80 with mild cognitive impairment (MCI)Until the end of the study, approximately 5 years

    The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.

  • Number of participants enrolled who are aged 45 to 80 with dementiaUntil the end of the study, approximately 5 years

    The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and the role of age, sex and genetics (especially APOE genotype) on their manifestation.