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Posiphen for Alzheimer's Disease (DISCOVER Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Annovis Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 55 to 89 years (inclusive), in good health, no frailty.
Clinical profile consistent with MCI or mild AD, consistent with the core clinical criteria outlined in the NIA-AA Guidelines (2011).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the confinement visit occurred following 21-23 days of treatment with either posiphen or placebo, while also allowing a +/- 2-day visit window. plasma was collected at 0, 2, 4, 8, 12, 16, 20, and 24hrs during the confinement visit.
Awards & highlights

DISCOVER Trial Summary

This trial looks at the safety and how Posiphen affects people with early Alzheimer's disease.

Eligible Conditions
  • Alzheimer's Disease

DISCOVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

DISCOVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the confinement visit occurred following 21-23 days of treatment with either posiphen or placebo, while also allowing a +/- 2-day visit window. plasma was collected at 0, 2, 4, 8, 12, 16, 20, and 24hrs during the confinement visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the confinement visit occurred following 21-23 days of treatment with either posiphen or placebo, while also allowing a +/- 2-day visit window. plasma was collected at 0, 2, 4, 8, 12, 16, 20, and 24hrs during the confinement visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fractional Synthesis Rate of Aβ40 in CSF Using the SILK™ Technique With Multiple Doses of Posiphen
Safety and Tolerability of Multiple Ascending Doses of Posiphen: Reports of Adverse Events or Study Discontinuations
The Levels of Posiphen and Its Metabolites Will be Determined in Cerebrospinal Fluid (CSF)
+1 more
Secondary outcome measures
Assessment of Cognitive Effects
Assessment of Mental Status Effects
Assessment of Neuropsychiatric Effects
+4 more
Other outcome measures
Absolute synthesis and clearance rates
Fractional synthesis rates with normalized SILK curve sampling

Side effects data

From 2022 Phase 1 & 2 trial • 75 Patients • NCT04524351
10%
procedural headache
10%
paraesthesia
10%
back pain
10%
headache
10%
constipation
10%
post lumbar puncture syndrome
10%
erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Posiphen, 40mg (Parkinson's Participants)
Posiphen, 20mg (Parkinson's Participants)
Posiphen, 10mg (Parkinson's Participants)
Posiphen, 80mg (Parkinson's Participants)
Posiphen, 5mg (Parkinson's Participants)
Placebo (Parkinson's Participants)
Placebo (Alzheimer's Participants)
Posiphen, 80mg (Alzheimer's Participants)

DISCOVER Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium DoseExperimental Treatment1 Intervention
The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days.
Group II: Low DoseExperimental Treatment1 Intervention
The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days.
Group III: High DoseExperimental Treatment1 Intervention
The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days.
Group IV: PlaceboPlacebo Group1 Intervention
The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Posiphen
2020
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Alzheimer's Disease Cooperative Study (ADCS)OTHER
24 Previous Clinical Trials
6,715 Total Patients Enrolled
Annovis Bio Inc.Lead Sponsor
4 Previous Clinical Trials
923 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I have the opportunity to join this medical experiment?

"This research requires 19 participants to meet the criteria of having Alzheimer's disease and being between 55-89 years old."

Answered by AI

Are there still opportunities to participate in this experiment?

"According to the clinicaltrials.gov website, this trial is no longer enrolling participants. Initially posted on March 2nd 2017 and last updated in August 1st 2022, it has been superseded by 547 other studies that are currently accepting patients into their trials."

Answered by AI

Is this experiment a pioneering initiative in its field?

"Since 2017, Annovis Bio Inc. has undertaken research into Posiphen's potential medicinal uses. The first trial in 2017 involved 19 participants and its results allowed for the drug to progress through Phase 1 & 2 of clinical trials. At present, there is one active study being sponsored by Annovis Bio Inc.."

Answered by AI

How many distinct sites are overseeing this research project?

"This investigation is being carried out at the UCSD Alzheimer's disease Research Center in La Jolla, California; IU Health Partners Adult Neurology Clinic located in Indianapolis, Indiana; and Washington University Sleep Medicine Centre situated in Brentwood, Missouri. Additionally, there are 3 other locations involved."

Answered by AI

Are there any other experiments conducted using Posiphen that have been documented?

"The first clinical trials of Posiphen were conducted in 2017 at the Columbia University Medical Center Sergievsky Center Taub Institute. A total of 18327 completed studies have been finished, with one ongoing trial located in La Jolla, California."

Answered by AI

Does the eligibility for this investigation encompass individuals over 45 years old?

"This trial has a clearly defined age bracket: participants must be aged 55 to 89. Moreover, there are 23 trials open for people younger than 18 and 537 available for those older than 65 years of age."

Answered by AI

What is the maximum number of participants currently allowed to partake in this clinical trial?

"At this juncture, the trial is not seeking out any new participants. It was first made available on March 2nd 2017 and its most recent update took place in August of 2022. If you wish to pursue further studies related to Alzheimer Disease or Posiphen, there are currently 546 and 1 trials respectively that are recruiting patients."

Answered by AI

What objectives is this medical research seeking to accomplish?

"Annovis Bio Inc., the study sponsor, has disclosed that its primary endpoint will be measuring Posiphen and metabolite levels in plasma over a 25-day intervals. Moreover, they intend to evaluate secondary objectives such as enrollment rates across participating sites, short-term cognitive effects of Posiphen using the Alzheimer's disease Assessment Scale (ADAS-Cog12), and qualitative responses from participants about their experience with study procedures."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease
2017. "Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02925650.
~2 spots leftby Apr 2025
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