NCT06703541 · Duke University
ADRC Clinical Cohort (Alzheimer's Disease)
What this study is about
The purpose of the study is to establish a clinical group of participants for the Duke/UNC Alzheimer's Disease Research Center (ADRC). The group of participants 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2025 · Source of record for eligibility and locations