ADRC Clinical Cohort (Alzheimer's Disease)

NCT06703541 | Recruiting

• 2 other identifiers: Pro001039581P30AG072958
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Number of participants enrolled who are aged 25 to 44 with normal cognition

  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.

  Until the end of the study, approximately 5 years

• Number of participants enrolled who are aged 45 to 80 with normal cognition

  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.

  Until the end of the study, approximately 5 years

• Number of participants enrolled who are aged 45 to 80 with mild cognitive impairment (MCI)

  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.

  Until the end of the study, approximately 5 years

• Number of participants enrolled who are aged 45 to 80 with dementia

  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.

  Until the end of the study, approximately 5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 25 to 44 at enrollment with normal cognition, and individuals aged 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or a dementia diagnosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

Related Links

• Duke/UNC Alzheimer's Disease Research Center website

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and cerebrospinal fluid samples will be obtained and stored.

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Heather E Whitson, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Dewees, MSW

CONTACT

919-660-2340; adrc@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: July 21, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)