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NCT05363293 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects
A Phase 1 study, sponsored by Alzamend Neuro.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT05363293: Completed Phase 1 study, sponsored by Alzamend Neuro.
NCT05363293 is a Phase 1 study that has completed, run by Alzamend Neuro. 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
NCT05363293, a Phase 1 study, has completed, sponsored by Alzamend Neuro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Up to 72 participants will be randomly assigned to receive study drug (active AL001) or placebo. The study consists of a 4-week screening period, a 14-day treatment period, and a 42-day follow-up period.
Primary Outcome
To evaluate the safety and tolerability of AL001 in healthy subjects and patients with adverse event(s), AD, descriptive statistics will be presented by treatment group for each cohort and overall, for the following: Proportion of participants with treatment-emergent adverse events (TEAEs) * Proportion of participants with serious AEs * Proportion of participants with TEAEs that lead to premature discontinuation * Proportion of participants with abnormal values for each safety laboratory test
Interventions
- OTHER Placebo
- DRUG AL001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-05-04 |
| Est. Completion | 2023-05-15 |
| Phase | Phase 1 |
What the finished NCT05363293 record still lists
NCT05363293 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.
NCT05363293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05363293 about?
NCT05363293 is a clinical study titled "Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects". This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Up to 72 participants will be randomly assigned to receive study drug (active AL001) or placebo. The study con...
What is the current status of trial NCT05363293?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2022-05-04. Estimated completion is 2023-05-15.
What interventions are being tested in trial NCT05363293?
The interventions under investigation include: Placebo (OTHER), AL001 (DRUG).
Who is sponsoring clinical trial NCT05363293?
This trial is sponsored by Alzamend Neuro, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05363293'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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