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Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition

StatusRecruiting
PhasePhase 2
Started2021-08-19
View on ClinicalTrials.gov ↗

Amendment history

2026-06-17
minor
Study Status, Contacts/Locations v9
Re-verified, no change to tracked fields
2026-06-16
minor
Study Status, Sponsor/Collaborators v8
Collaborators1 to 4 entries
Alzheimer's Association Fondation Jérôme Lejeune National Institute on Aging (NIA)
2026-05-15
notable
Active, Not Recruiting→Recruiting Study Status, Oversight, Study Design, Contacts/Locations v7
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2025-12-30→2027-04-30
Completion date2026-04-30→2027-04-30
Enrollment target20→30
Study sitesdetails revised at 1 of 1 site
2025-06-24
minor
Study Status, Oversight v6
Primary completion date2025-04-30→2025-12-30
Completion date2025-04-30→2026-04-30
2025-03-10
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-02-01→2025-04-30
Completion date2025-02-28→2025-04-30
Study sitesdetails revised at 1 of 1 site
Show 4 earlier versions
2024-12-11
minor
Study Status v4
Primary completion date2024-08-28→2025-02-01
Completion date2024-12-31→2025-02-28
2024-02-02
minor
Study Status v3
Primary completion date2024-02-28→2024-08-28
Completion date2024-08-19→2024-12-31
2023-01-31
minor
Study Status, Arms and Interventions, Contacts/Locations v2
InterventionsEEG recording (Diagnostic Test), MRI Scan (Diagnostic Test), [18F]-FEOBV Radiotracer (Drug)→[18F]-FEOBV Radiotracer (Drug)
2023-01-30
minor
Study Status, Oversight, Study Design, Arms and Interventions, Eligibility, IPDSharing v1
PhaseNot specified→Phase 2
Primary completion date2023-08-19→2024-02-28
Enrollment target15→20
InterventionsEEG recording (Other), Optional MRI Scan (Other), [18F]-FEOBV PET Scan (Radiation)→EEG recording (Diagnostic Test), MRI Scan (Diagnostic Test), [18F]-FEOBV Radiotracer (Drug)
2022-01-28
minor
Original filing
Progressive age-related cognitive deficits occurring in both AD and DS have been connected to the degeneration of several neuronal populations, but mechanisms are not fully elucidated. The most consistent neuronal losses throughout the progression of AD are seen in cholinergic neurons where these losses negatively affect cognition, particularly in attention, learning, and memory formation. Evidence of reduced cholinergic integrity in DS is largely limited to animal models and post-mortem human data. The investigators propose to use molecular, functional, and structural biomarkers to assess the cholinergic integrity in adults with DS. The investigators anticipate using the data gathered in this pilot study to inform future study designs to determine AD risk stratification in DS by identifying individuals who show an accelerated decline in cholinergic integrity that correlates with cognitive and neurobehavioral changes. Also, our cholinergic biomarkers may identify whether individuals with DS are likely to respond to pro-cholinergic interventions, including the novel cholinergic modulators that are being developed to enhance cholinergic-sensitive cognitive functioning. The investigators anticipate using the data gathered here to inform future treatment studies in TRC-DS and beyond where novel cholinergic treatments may offer opportunities for early intervention in DS and be complementary to disease-modifying approaches such as anti-amyloid treatments.
Trial Details
NCT Number NCT05231798
Lead Sponsor Vanderbilt University Medical Center
Collaborators: Vanderbilt Kennedy Center, Alzheimer's Association, Fondation Jérôme Lejeune, National Institute on Aging (NIA)
Conditions Down Syndrome, Down Syndrome, Partial Trisomy 21, Alzheimer Disease
Enrollment 30 participants
Start Date 2021-08-19
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-22