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NCT05004688 · ClinicalTrials.gov registry record · Phase 2
A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD
A Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Steven E Arnold, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05004688: Completed Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Steven E Arnold, MD.
NCT05004688 is a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment that has completed, run by Steven E Arnold, MD. The registered enrollment target is 15 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05004688, a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, has completed, sponsored by Steven E Arnold, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
A study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older with mild cognitive impairment and mild-to-moderate to Alzheimer's disease.
Primary Outcome
Change in concentration (Average difference) of circulating cytokines in blood from baseline (Average difference).Cytokines include: Plasma IFN-g (pg/ml), Plasma IL-1b (pg/ml), Plasma IL-2 (pg/ml), Plasma IL-6 (pg/ml), Plasma IL-10 (pg/ml), Plasma TNF-a (pg/ml). Mean differences (and standard deviations) from baseline values are presented for the Day 364 (end of study) sample collections for the 4 participants in the study.
Conditions Studied
Interventions
- BIOLOGICAL Biological/Vaccine: Bacillus Calmette-Guerin (BCG)
Study Locations (1)
Massachusetts
- Alzheimer's Clinical and Translational Research Unit - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-03-25 |
| Est. Completion | 2024-01-15 |
| Phase | Phase 2 |
What the finished NCT05004688 record still lists
NCT05004688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which Biological/Vaccine: Bacillus Calmette-Guerin (BCG) is the first listed.
NCT05004688 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05004688 about?
NCT05004688 is a clinical study titled "A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD". A study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older with mild cognitive impairment and mild-to-moderate to Alzheimer's disease.
What is the current status of trial NCT05004688?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2022-03-25. Estimated completion is 2024-01-15.
What conditions does trial NCT05004688 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia, Moderate Dementia.
What interventions are being tested in trial NCT05004688?
The interventions under investigation include: Biological/Vaccine: Bacillus Calmette-Guerin (BCG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05004688?
This trial is sponsored by Steven E Arnold, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05004688 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05004688's enrollment target sits among peer trials
15 279th of 306 higher than 24 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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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