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NCT05896332 · ClinicalTrials.gov registry record · Phase 1
rTMS in Older Adults With MCI and AUD
A Phase 1 study of Mild Cognitive Impairment and Alcohol Use Disorder, sponsored by Medical University of South Carolina.
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT05896332: Active Phase 1 study of Mild Cognitive Impairment and Alcohol Use Disorder, sponsored by Medical University of South Carolina.
NCT05896332 is a Phase 1 study of Mild Cognitive Impairment and Alcohol Use Disorder that is active but no longer recruiting, run by Medical University of South Carolina. The registered enrollment target is 35 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05896332, a Phase 1 study of Mild Cognitive Impairment and Alcohol Use Disorder, is active but no longer recruiting, sponsored by Medical University of South Carolina.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study Summary
Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to drinking escalation. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognition in Alzheimer's Disease and Related Dimentias (ADRD) and separately reduce heavy drinking in alcohol use disorder. Our objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults.
Primary Outcome
The NIHTB-CB is a performance-based, iPad-administered \~30-minute suite of 7 tests that ascertain abilities in different cognitive domains (i.e. executive function, episodic memory, working memory, processing speed, language). It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores. We will use the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicating better cognition) of the Fluid Cognit
Conditions Studied
Interventions
- DEVICE Active, Open Label iTBS-rTMS
Study Locations (2)
South Carolina
- Medical Univeristy of South Carolina - Charleston
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
What the registry record for NCT05896332 still lists
NCT05896332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 1 intervention - of which Active, Open Label iTBS-rTMS is the first listed.
NCT05896332 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05896332 about?
NCT05896332 is a clinical study titled "rTMS in Older Adults With MCI and AUD". Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to ...
What is the current status of trial NCT05896332?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2023-11-01. Estimated completion is 2025-12-01.
What conditions does trial NCT05896332 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Alcohol Use Disorder, Transcranial Magnetic Stimulation.
What interventions are being tested in trial NCT05896332?
The interventions under investigation include: Active, Open Label iTBS-rTMS (DEVICE).
Who is sponsoring clinical trial NCT05896332?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05896332 being conducted?
This trial has 2 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05896332's enrollment target sits among peer trials
35 158th of 205 higher than 46 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment 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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