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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 is a Phase 1 study that has completed, run by Alzamend Neuro. The registered enrollment target is 65 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05363293
The ClinicalTrials.gov registry entry for NCT05363293 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alzamend Neuro, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05363293 reports 0 study locations.
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.
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