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NCT04931459 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD
A Phase 1 study, sponsored by Acumen Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT04931459: Completed Phase 1 study, sponsored by Acumen Pharmaceuticals.
NCT04931459 is a Phase 1 study that has completed, run by Acumen Pharmaceuticals. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04931459, a Phase 1 study, has completed, sponsored by Acumen Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
This Phase 1 study is a single ascending dose (SAD) and multiple ascending dose (MAD), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ACU193 when administered to participants diagnosed with Mild Cognitive Impairment (MCI) or Mild Dementia due to Alzheimer's disease (AD).
Primary Outcome
Proportion of participants with AE, discontinuations due to AE or SAE, and withdrawals from the study due to AE
Interventions
- DRUG Placebo
- DRUG ACU193
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2023-06-12 |
| Phase | Phase 1 |
What the finished NCT04931459 record still lists
NCT04931459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04931459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04931459 about?
NCT04931459 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD". This Phase 1 study is a single ascending dose (SAD) and multiple ascending dose (MAD), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ACU193 when administered to participants diagnosed with Mild Cognitive Impairment (MCI...
What is the current status of trial NCT04931459?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2021-06-21. Estimated completion is 2023-06-12.
What interventions are being tested in trial NCT04931459?
The interventions under investigation include: Placebo (DRUG), ACU193 (DRUG).
Who is sponsoring clinical trial NCT04931459?
This trial is sponsored by Acumen Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04931459's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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