Actively Recruiting
Duke/UNC Alzheimer's Disease Center Clinical Cohort for Normal Cognition, Mild Cognitive Impairment, and Dementia Research
Led by Duke University · Updated on 2025-08-24
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are establishing a clinical cohort for the Duke/UNC Alzheimer's Disease Research Center to study adults aged 25 to 80. The group includes people with normal cognition, mild cognitive impairment, or dementia related to Alzheimer's disease and other dementias. The study aims to understand how age, sex, genetics, and environmental factors affect these conditions and to create a repository of biological samples for further research. Participants aged 25 to 44 with normal cognition and those aged 45 to 80 with varying cognitive status will undergo baseline visits that include medical history, physical exams, neuropsychological testing, blood and urine collection, lumbar puncture or PET scans, retinal imaging, and MRI. The older group will have a study partner and annual follow-ups to update medical information, repeat testing, and possibly collect more samples or imaging until death or withdrawal. Throughout the study, participants and their study partners will provide data on cognition, behavior, and health through yearly assessments. A consensus committee reviews each case at baseline and annually to confirm diagnoses. All collected data and biological samples are coded, stored securely, and may be shared with other research centers while protecting participant privacy. The study duration is approximately five years with ongoing monitoring and data collection.
CONDITIONS
Brief Title
ADRC Clinical Cohort (Alzheimer's Disease)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 25 and 80 years old
- Able to read at a 6th grade level or higher
- Provide signed informed consent before any screening assessments
- Willing to have an MRI and lumbar puncture, or alternatively, PET scans
- Participants aged 45 to 80 must have a study partner who also meets reading and cognitive criteria and agrees to participate
You will not qualify if you...
- Have an unstable or significant neurological disorder such as multiple head injuries, stroke, multiple sclerosis, or Parkinson's disease
- Have an unstable or significant psychiatric disorder
- History of alcoholism or drug abuse within the last 2 years
- GAD-7 score greater than 9 and/or PHQ-8 score greater than 9
- Have an uncontrolled medical condition that poses significant risk to participation
- Have contraindications or intolerance to 3T MRI, including implanted devices
- History of cancer within the past 5 years, except certain localized skin or cervical cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Typically completed within 60 days
Participants undergo baseline visits including consent, collection of medical and family history, physical and neurological exams, neuropsychological testing, blood and urine samples, retinal imaging, MRI, and lumbar puncture or PET scan as applicable to confirm diagnosis.
Typically over 3 visits
Duration - Up to 5 years or until the time of death
Participants aged 45 to 80 and their project partners are contacted approximately every 12 months for yearly follow-up evaluations including medical history updates, physical exam, neuropsychological testing, and possibly additional blood, cerebrospinal fluid, or imaging samples.
Annual visits, ideally in person but may be by telephone if necessary
Trial Site Locations
Total: 1 location
1
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
R
Rachel Dewees, MSW
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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