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NCT05606341 · ClinicalTrials.gov registry record · Phase 1
Innate Immunity Stimulation Via TLR9 in Early AD
A Phase 1 study of Mild Cognitive Impairment and Alzheimer Dementia, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05606341: Recruiting Phase 1 study of Mild Cognitive Impairment and Alzheimer Dementia, sponsored by NYU Langone Health.
NCT05606341 is a Phase 1 study of Mild Cognitive Impairment and Alzheimer Dementia that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 18 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment 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
NCT05606341, a Phase 1 study of Mild Cognitive Impairment and Alzheimer Dementia, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer's disease (MCI) or Mild Alzheimer's disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg/kg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg/kg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg/kg vs. placebo) for 8 weeks. The primary objective will be to assess safety and tolerability of CpG 1018.
Primary Outcome
AEs defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CpG1018
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What NCT05606341 shows while recruiting
NCT05606341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05606341 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05606341 about?
NCT05606341 is a clinical study titled "Innate Immunity Stimulation Via TLR9 in Early AD". This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer's disease (MCI) or Mild Alzheimer's disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to ...
What is the current status of trial NCT05606341?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-03-13. Estimated completion is 2026-11.
What conditions does trial NCT05606341 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Alzheimer Dementia.
What interventions are being tested in trial NCT05606341?
The interventions under investigation include: Placebo (DRUG), CpG1018 (DRUG).
Who is sponsoring clinical trial NCT05606341?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05606341 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mild Cognitive Impairment
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 NCT05606341's enrollment target sits among peer trials
18 184th of 205 higher than 21 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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