Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients

Phase 1

Completed

• Conditions: Alzheimer Disease; Parkinson Disease
• Interventions: Drug: Placebo; Drug: Posiphen

• Registration Number: NCT04524351
• Lead Sponsor: Annovis Bio Inc.

Brief 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.

Detailed Description

Part 1 is a study with 14 Early AD and 14 Early PD patients who are randomized to 80 mg of Posiphen or placebo. Participants will undergo a Screening Visit, provide informed consent and be evaluated for eligibility per the inclusion and exclusion criteria. If enrolled, participants will proceed to the randomized treatment portions of the study. Period 1 consists of first-time dosing in clinic with administration of 80 mg of Posiphen or Placebo. Period 2 consists of an at home dosing period of 25±2 days, with daily administration of 80 mg of Posiphen or Placebo. Period 3 will be comprised of a stay at the clinical research unit where the subject will undergo study procedures that include safety assessments (AE and concomitant medication monitoring, 12-lead ECGs, clinical laboratory testing, vital signs assessments, and physical examinations), the last dose of Posiphen or Placebo, and 6 hours of blood and CSF sampling. At the end of blood/CSF sampling, the subjects will need to stay for a minimum of 1 hour of observation but may stay if necessary for observation until the following day (e.g., if the subject has blood/CSF sampling on Day 25, he/she may stay for observation until Day 26). After all end-of-study procedures are complete, the subject will be discharged to home. A 24-hour follow-up call will occur to assess the participants current condition and if there are any additional adverse events to report.

After completion of Part 1 of the study, the plasma and CSF samples will be analyzed for the biomarkers to determine if changes are needed to the biomarkers to be measured in Part 2. Since the conduct of the study in Part 2 will be identical to the conduct of the study in Part 1, recruitment will continue uninterrupted. The only potential change between Part 1 and Part 2 are the biomarkers to be measured.

Part 2 is a study with 40 Early PD patients, 10 patients each who are randomized to one of 4 treatment conditions of Posiphen (5 mg, 10 mg, 20 mg, or 40 mg). Participants will undergo a Screening Visit, provide informed consent and be evaluated for eligibility per the inclusion and exclusion criteria. If enrolled, participants will proceed to the randomized treatment portions of the study. Period 1 consists of first-time dosing in clinic with administration of 5, 10, 20, or 40mg of Posiphen. Period 2 consists of an at home dosing period of 25±2 days, with daily administration of 5, 10, 20, or 40mg of Posiphen. Period 3 will be comprised of a stay at the clinical research unit where the subject will undergo study procedures that include safety assessments (AE and concomitant medication monitoring, 12-lead ECGs, clinical laboratory testing, vital signs assessments, and physical examinations), the last dose of Posiphen or Placebo, and 6 hours of blood and CSF sampling. At the end of blood/CSF sampling, the subject will need to stay for a minimum of 1 hour of observation but may stay if necessary for observation until the following day (e.g., if the subject has blood/CSF sampling on Day 25, he/she may stay for observation until Day 26). After all end-of-study procedures are complete, the subject will be discharged to home. A 24-hour follow-up call will occur to assess the participant's current condition and if there are any additional adverse events to report.

Study Timeline

• Study First Submitted: 2020-08-11
• Study Start: 2020-08-14
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-24
• Primary Completion: 2021-08-16
• Study Completion: 2022-01-31
• Results First Submitted: 2023-01-11
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Results First Posted: 2023-02-28
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Parkinson's Participants)	Placebo	Placebo Oral Capsule, taken once per day for 25±2 days.
Placebo (Alzheimer's Participants)	Placebo	Placebo Oral Capsule, taken once per day for 25±2 days.
Posiphen, 80mg (Alzheimer's Participants)	Posiphen	Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days.
Posiphen, 40mg (Parkinson's Participants)	Posiphen	Posiphen Oral Capsule, 40mg, taken once per day for 25±2 days.
Posiphen, 80mg (Parkinson's Participants)	Posiphen	Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days.
Posiphen, 20mg (Parkinson's Participants)	Posiphen	Posiphen Oral Capsule, 20mg, taken once per day for 25±2 days.
Posiphen, 5mg (Parkinson's Participants)	Posiphen	Posiphen Oral Capsule, 5mg, taken once per day for 25±2 days.
Posiphen, 10mg (Parkinson's Participants)	Posiphen	Posiphen Oral Capsule, 10mg, taken once per day for 25±2 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-Emergent Adverse Events	25±2 days	Percent of patients with AEs in the Posiphen treatment arms compared to the Placebo group

Secondary Outcome Measures

Name	Time	Method
Concentration of Posiphen in Plasma	Samples collected over a 6 hour timeframe	Maximum Plasma Concentration (Cmax) of Posiphen reported as ng/mL.

Trial Locations

Locations (13)

Hawaii Pacific Neuroscience; 🇺🇸 Honolulu, Hawaii, United States

DeLand Clinical Research Unit; 🇺🇸 DeLand, Florida, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Aspen Clinical Research LLC; 🇺🇸 Orem, Utah, United States

New England Institute for Clinical Research; 🇺🇸 Stamford, Connecticut, United States

Homestead Associates in Research; 🇺🇸 Miami, Florida, United States

Ezy Medical Research Co.; 🇺🇸 Miami, Florida, United States

Quest Research Institute; 🇺🇸 Farmington Hills, Michigan, United States

Penn Medicine, Department of Neurology, U of PA; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States

Conquest Research LLC; 🇺🇸 Winter Park, Florida, United States

iResearch Atlanta, LLC; 🇺🇸 Decatur, Georgia, United States

North Suffolk Neurology, PC; 🇺🇸 Port Jefferson Station, New York, United States