Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06703541

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Dementia

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Dementia

Study ID

NCT06703541

Start date

Jul 21, 2020

Status verified date

Aug, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants aged 25-44

Subjects ages 25 to 44 at enrollment with normal cognition will undergo baseline visits including:

  • Demographics
  • Family history, medical history, current medications
  • General physical and neurological exam, sensory and motor testing
  • Vital signs
  • Blood sample collected for PT/INR, blood count, genetic testing, and storage for future unspecified research on cognition and disorders associated with altered cognition
  • Urine sample
  • Neuropsychological testing
  • Retinal imaging
  • Testing of memory, thought processes, and recognition
  • MRI
  • Lumbar puncture

Participants aged 45-80

Subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or dementia will undergo baseline visits including:

  • Demographics and project partner demographics
  • Family history, medical history, current medications
  • General physical and neurological exam, sensory and motor testing
  • Vital signs
  • Blood sample collected for PT/INR, blood count, genetic testing, and storage for future unspecified research on cognition and disorders associated with altered cognition
  • Urine sample
  • Neuropsychological testing
  • Retinal imaging
  • Testing of memory, thought processes, and recognition
  • MRI
  • Lumbar puncture

Participants will be asked to participate in yearly evaluations until the time of death. Participants can withdraw at any time.

Primary outcome measure

  • Number of participants enrolled who are aged 25 to 44 with normal cognition [ Time Frame: Until the end of the study, approximately 5 years ]
  • Number of participants enrolled who are aged 45 to 80 with normal cognition [ Time Frame: Until the end of the study, approximately 5 years ]
  • Number of participants enrolled who are aged 45 to 80 with mild cognitive impairment (MCI) [ Time Frame: Until the end of the study, approximately 5 years ]
  • Number of participants enrolled who are aged 45 to 80 with dementia [ Time Frame: Until the end of the study, approximately 5 years ]

Central Contacts and Locations

Central contacts

Rachel Dewees, MSW

919-660-2340adrc@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Rachel Dewees, MSW

919-660-2340adrc@duke.edu

Principal Investigator:

Heather E Whitson, MD, MHS

More Information

Sponsor

Duke University

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Genetic risk
  • Alzheimer Disease
  • Dementia
  • Aging
  • Alzheimer's Disease Research Center (ADRC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.