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NCT07284290 · ClinicalTrials.gov registry record · Phase 4
Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
A Phase 4 study of Dementia With Lewy Bodies and Healthy (Controls), sponsored by Virginia Commonwealth University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07284290: Recruiting Phase 4 study of Dementia With Lewy Bodies and Healthy (Controls), sponsored by Virginia Commonwealth University.
NCT07284290 is a Phase 4 study of Dementia With Lewy Bodies and Healthy (Controls) that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 120 participants, below the 466-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07284290, a Phase 4 study of Dementia With Lewy Bodies and Healthy (Controls), is actively recruiting participants, sponsored by Virginia Commonwealth University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. One of the overarching innovations of study is combining all of these assessments into one integrated research plan
Primary Outcome
The scoring for the Clinical Assessment of Fluctuations (CAF) is a two-step process that uses both a frequency and a duration score. The two scores are multiplied together to get the final severity rating. A higher score indicates more severe cognitive fluctuations. After rating the frequency and duration, the two scores are multiplied to get the final CAF score. Frequency score x Duration score=Total CAF score
Conditions Studied
Interventions
- PROCEDURE Syn-One skin biopsy
- DIAGNOSTIC_TEST Multi modal MRI
- DIAGNOSTIC_TEST Assessment of dynamic EEG features over 48-hour periods across all study aims
- DIAGNOSTIC_TEST Plasma biomarkers
- DRUG Galantamine HBr extended-release 8mg capsules (8mg ER).
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-12-08 |
| Est. Completion | 2029-11 |
| Phase | Phase 4 |
What NCT07284290 shows while recruiting
NCT07284290 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 466-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Dementia With Lewy Bodies appearing as the primary indexed condition, and to 5 interventions - of which Syn-One skin biopsy is the first listed.
NCT07284290 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT07284290 about?
NCT07284290 is a clinical study titled "Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia". The proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. ...
What is the current status of trial NCT07284290?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2025-12-08. Estimated completion is 2029-11.
What conditions does trial NCT07284290 study?
This clinical trial studies the following conditions: Dementia With Lewy Bodies, Healthy (Controls), Parkinson Disease Dementia.
What interventions are being tested in trial NCT07284290?
The interventions under investigation include: Syn-One skin biopsy (PROCEDURE), Multi modal MRI (DIAGNOSTIC_TEST), Assessment of dynamic EEG features over 48-hour periods across all study aims (DIAGNOSTIC_TEST), Plasma biomarkers (DIAGNOSTIC_TEST), Galantamine HBr extended-release 8mg capsules (8mg ER). (DRUG).
Who is sponsoring clinical trial NCT07284290?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07284290 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07284290's enrollment target sits among peer trials
120 13th of 22 higher than 10 of 22 other Dementia With Lewy Bodies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia With Lewy Bodies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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