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NCT04524351 · ClinicalTrials.gov registry record · Phase 1
Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients
A Phase 1 study, sponsored by Annovis Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT04524351: Completed Phase 1 study, sponsored by Annovis Bio.
NCT04524351 is a Phase 1 study that has completed, run by Annovis Bio. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524351, a Phase 1 study, has completed, sponsored by Annovis Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
Annovis is conducting a clinical study to investigate Posiphen in patients with Early Alzheimer's Disease (AD) and Early Parkinson's Disease (PD). Investigators are looking to recruit 68 patients in two parts of the study. In Part one of the study Investigators will recruit 14 AD and 14 PD patients who will either receive placebo (an inert pill which looks like the study drug) or the study drug Posiphen, both taken daily. In Part two of the study Investigators will recruit 40 PD patients who will receive different strengths of the study drug Posiphen taken daily. Patients will be required to come to the site for 3 face to face visits and have 4 phone calls, tests include but are not limited to, blood and CSF (spinal fluid) sampling, cognitive assessments, clinical examinations and laboratory safety tests. Primarily the Investigators are looking for the safety and tolerability of Posiphen, although Investigators will also evaluate the activity of Posiphen by a number of different biomarkers measuring pathway and target engagements.
Primary Outcome
Percent of patients with AEs in the Posiphen treatment arms compared to the Placebo group
Interventions
- DRUG Placebo
- DRUG Posiphen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2020-08-14 |
| Est. Completion | 2022-01-31 |
| Phase | Phase 1 |
What the finished NCT04524351 record still lists
NCT04524351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04524351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04524351 about?
NCT04524351 is a clinical study titled "Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients". Annovis is conducting a clinical study to investigate Posiphen in patients with Early Alzheimer's Disease (AD) and Early Parkinson's Disease (PD). Investigators are looking to recruit 68 patients in two parts of the study. In Part one of the study Investigators will recruit 14 AD and 14 PD patients ...
What is the current status of trial NCT04524351?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2020-08-14. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT04524351?
The interventions under investigation include: Placebo (DRUG), Posiphen (DRUG).
Who is sponsoring clinical trial NCT04524351?
This trial is sponsored by Annovis Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04524351's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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