Actively Recruiting
Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition
Led by Vanderbilt University Medical Center · Updated on 2026-05-19
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
V
Vanderbilt Kennedy Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how age-related cognitive decline in adults with Down syndrome (DS) is linked to changes in the brain's cholinergic system, which is important for attention, learning, and memory. This study focuses on understanding these changes in relation to Alzheimer's disease (AD) pathology and cognitive performance. The goal is to identify early markers of dementia risk in DS and to support future treatments that target cholinergic function alongside other AD therapies. Participants will undergo various tests to measure cholinergic integrity, including brain scans with a special radiotracer ([18F]-FEOBV) used in PET imaging, structural MRI to assess brain regions, and EEG during rest and tasks. Adults with DS aged 18 to 55 will take part, including some from an existing cohort. The study uses these molecular, functional, and structural biomarkers to track changes associated with aging and AD in DS. Throughout the study, participants will have imaging scans, EEG recordings, and cognitive assessments to evaluate brain function and behavior. Researchers will analyze the correlation between radiotracer uptake and brain volume as the primary outcome. The study lasts about three years, with measures taken to ensure participant safety and monitoring cognitive changes over time to better understand the progression of AD in individuals with DS.
CONDITIONS
Brief Title
Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Down syndrome, including mosaic or partial trisomy 21
- Signed informed consent and assent if needed, with a legally authorized representative
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 to 55 inclusive
- In good general health with no diagnosis of dementia
- Stable dose of permitted CNS-active medications for at least 4 weeks
- Adequate vision and hearing for neuropsychological testing
- Negative pregnancy test for females who are not surgically sterile or post-menopausal
- Mental age of 4 years or greater based on Kaufman Brief Intelligence Test, 2nd Edition
- English as first or native language
- Reliable study partner able to provide clinical symptom information
You will not qualify if you...
- Any significant or unstable medical condition affecting neuropsychological testing
- Contraindications to MRI such as pacemaker, metallic fragments near eyes or spinal cord, or cochlear implants
- Inability to complete MRI and PET procedures
- IQ less than 40 as assessed by Kaufman Brief Intelligence Test, 2nd Edition
- Pregnancy or breastfeeding
- History of malignant disease within last 5 years except certain skin or in situ cancers
- Clinically significant abnormalities in B12 or thyroid tests not resolved by follow-up
- Abnormal screening laboratory tests
- Blood clotting or bleeding disorders if undergoing CSF collection
- Considered ineligible by site principal investigator
- Clinical diagnosis of dementia
- Concurrent participation in other clinical trials or longitudinal studies with overlapping measures
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 - One-time procedures during the study period
Participants receive an injection of an [18F]-FEOBV radiotracer followed by PET scans, MRI scans, and EEG assessments to evaluate cholinergic integrity and Alzheimer's disease pathology.
1 to 2 visits for imaging and EEG assessments
Duration - Up to 3 years
Participants are monitored for changes in cognitive and neurobehavioral performance related to cholinergic system integrity and Alzheimer's disease biomarkers.
Periodic follow-up assessments as scheduled
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center Clinical Research Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
A
Amy Boegel, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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