Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients
Public ClinicalTrials.gov record NCT04524351. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD) or Early Parkinson's Disease (PD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04524351
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 45 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 13, 2020
- Primary completion
- Aug 15, 2021
- Completion
- Jan 30, 2022
- Last update posted
- Feb 27, 2023
2020 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | — |
| DeLand Clinical Research Unit | DeLand | Florida | 32720 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Homestead Associates in Research | Miami | Florida | 33032 | — |
| Ezy Medical Research Co. | Miami | Florida | 33175 | — |
| Conquest Research LLC | Winter Park | Florida | 32789 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| North Suffolk Neurology, PC | Port Jefferson Station | New York | 11776 | — |
| Penn Medicine, Department of Neurology, U of PA | Philadelphia | Pennsylvania | 19107 | — |
| University of Texas Health Science Center | San Antonio | Texas | 78229 | — |
| Aspen Clinical Research LLC | Orem | Utah | 84058 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04524351, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2023 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04524351 live on ClinicalTrials.gov.