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NCT05231798 · ClinicalTrials.gov registry record · Phase 2
Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition
A Phase 2 study of Alzheimer Disease and Down Syndrome, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05231798 is a Phase 2 study of Alzheimer Disease and Down Syndrome that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 20 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05231798, a Phase 2 study of Alzheimer Disease and Down Syndrome, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG [18F]-FEOBV Radiotracer
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center Clinical Research Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05231798
The ClinicalTrials.gov registry entry for NCT05231798 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which [18F]-FEOBV Radiotracer is the first listed.
NCT05231798 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05231798 about?
NCT05231798 is a clinical study titled "Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition". 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 lo...
What is the current status of trial NCT05231798?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-08-19. Estimated completion is 2026-04-30.
What conditions does trial NCT05231798 study?
This clinical trial studies the following conditions: Alzheimer Disease, Down Syndrome, Down Syndrome, Partial Trisomy 21.
What interventions are being tested in trial NCT05231798?
The interventions under investigation include: [18F]-FEOBV Radiotracer (DRUG).
Who is sponsoring clinical trial NCT05231798?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05231798 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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