Alzheimer DiseasePhase 1/2NCT04524351
Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients
A Phase 1/2 study testing Posiphen in people with Alzheimer Disease and Parkinson Disease, run by Annovis Bio Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Alzheimer Disease, Parkinson Disease
- What is being tested?
- Posiphen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 13 sitesUnited States
- Study dates
- 14 Aug 2020to 31 Jan 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following criteria:
- Male or female aged 45 years and over.
- Female participants must be of non-childbearing potential or post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening.
- Female participants will be given a urine pregnancy test at the screening visit for which they should test negative.
- A) AD - CDR = 0.5 or 1. B) PD - Hoehn \& Yahr ≤ 4; PD criteria by MDS-UPDRS.
- A) AD MMSE score between the range of 18 to 28. B) PD MMSE score between the range of 18 to 30.
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- General cognition and functional performance sufficiently preserved that the subject can provide written informed consent.
- No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale.
- MRI scan within the 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. Lacunes that are not believed to contribute to the subject's cognitive impairment are permissible. If there is no MRI available within a 12-month timeframe, then an MRI must be performed as part of the screening procedures for eligibility.
- Stability of permitted medications prior to screening.
- Stable for at least 12 weeks: Cholinesterase inhibitors and/or memantine medication
- Stable for at least 4 weeks:
- Anti-parkinsonian medication ii. Anticonvulsant medications used for epilepsy or mood stabilization; neuropathic pain indications iii. Mood-stabilizing psychotropic agents, including, but not limited to, lithium.
- Adequate visual and hearing ability (physical ability to perform all the study assessments).
- Good general health with no disease expected to interfere with the study.
- Subjects previously exposed to Posiphen may be included in the study.
Who cannot join
- Subjects meeting any of the following criteria must not be included in the study:
- Has a history of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Mild depression or history of depression that is stable on treatment with a SSRI or SNRI medication at a stable dose is acceptable.
- History of a seizure disorder.
- Has a history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450ms, or torsades de pointes.
- Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening.
- Has uncontrolled Type-1 or Type-2 diabetes . A Subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject's diabetes is under control.
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- Has clinically significant renal or hepatic impairment.
- Has any clinically significant abnormal laboratory values. Subjects with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice the upper limit of normal will be excluded.
- Is at imminent risk of self-harm, based on clinical interview and responses on the C SSRS, or of harm to others in the opinion of the Investigators. Subjects must be excluded if they report suicidal ideation with intent, with or without a plan or method (e.g. positive response to Items 4 or 5 in assessment of suicidal ideation on the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months.
- Has four or more signal hypointensities on T2*-weighted gradient recalled echo magnetic resonance sequences that are thought to represent hemosiderin deposits including microhemorrhages and superficial siderosis or evidence of acute or sub-acute micro or microhemorrhage as noted on the MRI scan.
- Has cancer or has had a malignant tumor within the past year, except patients who underwent potentially curative therapy with no evidence of recurrence. (Patients with stable untreated prostate cancer or skin cancers are not excluded).
- Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM.
- Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 60 days prior to the start of screening. (The end of a previous investigational trial is the date the last dose of an investigational agent was taken), or five half-lives of the investigational drug, whichever is greater.
- Subjects with infection or inflammation of the skin or skin disease at or in proximity to the lumbar puncture site.
- History of lumbar spine surgery or chronic low back pain (CLBP).
- Subjects with learning disability or developmental delay.
- Subjects whom the site PI deems to be otherwise ineligible.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
iResearch Atlanta, LLC
Decatur, Georgia, 30030
DeLand Clinical Research Unit
DeLand, Florida, 32720
Quest Research Institute
Farmington Hills, Michigan, 48334
MD Clinical
Hallandale, Florida, 33009
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Homestead Associates in Research
Miami, Florida, 33032
Ezy Medical Research Co.
Miami, Florida, 33175
Aspen Clinical Research LLC
Orem, Utah, 84058
Penn Medicine, Department of Neurology, U of PA
Philadelphia, Pennsylvania, 19107
North Suffolk Neurology, PC
Port Jefferson Station, New York, 11776
University of Texas Health Science Center
San Antonio, Texas, 78229
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Conquest Research LLC
Winter Park, Florida, 32789
About this study
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)
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.
Read the 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.
- Conditions
- Alzheimer Disease, Parkinson Disease
- Being tested
- Posiphen, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Neurotoxic proteins, Neurotransmitters, Amyloid Precursor Proteins, Inflammatory factors, Synaptic factors, CSF
- Medical subject headings
- Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosiphenDrug
Solid oral dosage form, capsule
PlaceboDrug
Solid oral dosage form, capsule
| Study group | Role | What they receive |
|---|---|---|
| Posiphen, 80mg (Parkinson's Participants) | Active comparator | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. Receives: Drug: Posiphen |
| Posiphen, 40mg (Parkinson's Participants) | Active comparator | Posiphen Oral Capsule, 40mg, taken once per day for 25±2 days. Receives: Drug: Posiphen |
| Posiphen, 20mg (Parkinson's Participants) | Active comparator | Posiphen Oral Capsule, 20mg, taken once per day for 25±2 days. Receives: Drug: Posiphen |
| Posiphen, 10mg (Parkinson's Participants) | Active comparator | Posiphen Oral Capsule, 10mg, taken once per day for 25±2 days. Receives: Drug: Posiphen |
| Posiphen, 5mg (Parkinson's Participants) | Active comparator | Posiphen Oral Capsule, 5mg, taken once per day for 25±2 days. Receives: Drug: Posiphen |
| Placebo (Parkinson's Participants) | Placebo comparator | Placebo Oral Capsule, taken once per day for 25±2 days. Receives: Drug: Placebo |
| Placebo (Alzheimer's Participants) | Placebo comparator | Placebo Oral Capsule, taken once per day for 25±2 days. Receives: Drug: Placebo |
| Posiphen, 80mg (Alzheimer's Participants) | Active comparator | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. Receives: Drug: Posiphen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Adverse Events
Percent of patients with AEs in the Posiphen treatment arms compared to the Placebo group
Measured: 25±2 days
Secondary outcomes (1)
Concentration of Posiphen in Plasma
Maximum Plasma Concentration (Cmax) of Posiphen reported as ng/mL.
Measured: Samples collected over a 6 hour timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start14 Aug 2020
- Primary completion16 Aug 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annovis Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524351
- Sponsor's protocol ID
- ANVS-12003
- Status last verified
- Feb 2023
- First submitted
- 11 Aug 2020
- Last updated
- 28 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fang C, Hernandez P, Liow K, Damiano E, Zetterberg H, Blennow K, Feng D, Chen M, Maccecchini M. Buntanetap, a Novel Translational Inhibitor of Multiple Neurotoxic Proteins, Proves to Be Safe and Promising in Both Alzheimer's and Parkinson's Patients. J Prev Alzheimers Dis. 2023;10(1):25-33. doi: 10.14283/jpad.2022.84.
PubMed 36641607
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04524351
- Acronym / sponsor ID
- ANVS-12003
- Conditions
- Alzheimer Disease, Parkinson Disease
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Neurotoxic proteins, Neurotransmitters, Amyloid Precursor Proteins, Inflammatory factors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Annovis Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Posiphen, 80mg (Parkinson's Participants) | Active comparator | Drug: PosiphenPosiphen Oral Capsule, 80mg, taken once per day for 25±2 days. |
| Posiphen, 40mg (Parkinson's Participants) | Active comparator | Drug: PosiphenPosiphen Oral Capsule, 40mg, taken once per day for 25±2 days. |
| Posiphen, 20mg (Parkinson's Participants) | Active comparator | Drug: PosiphenPosiphen Oral Capsule, 20mg, taken once per day for 25±2 days. |
| Posiphen, 10mg (Parkinson's Participants) | Active comparator | Drug: PosiphenPosiphen Oral Capsule, 10mg, taken once per day for 25±2 days. |
| Posiphen, 5mg (Parkinson's Participants) | Active comparator | Drug: PosiphenPosiphen Oral Capsule, 5mg, taken once per day for 25±2 days. |
| Placebo (Parkinson's Participants) | Placebo comparator | Drug: PlaceboPlacebo Oral Capsule, taken once per day for 25±2 days. |
| Placebo (Alzheimer's Participants) | Placebo comparator | Drug: PlaceboPlacebo Oral Capsule, taken once per day for 25±2 days. |
| Posiphen, 80mg (Alzheimer's Participants) | Active comparator | Drug: PosiphenPosiphen Oral Capsule, 80mg, taken once per day for 25±2 days. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female aged 45 years and over.
- Female participants must be of non-childbearing potential or post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening.
- Female participants will be given a urine pregnancy test at the screening visit for which they should test negative.
- A) AD - CDR = 0.5 or 1. B) PD - Hoehn \& Yahr ≤ 4; PD criteria by MDS-UPDRS.
- A) AD MMSE score between the range of 18 to 28. B) PD MMSE score between the range of 18 to 30.
Key exclusion criteria (17 listed)
- Has a history of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Mild depression or history of depression that is stable on treatment with a SSRI or SNRI medication at a stable dose is acceptable.
- History of a seizure disorder.
- Has a history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450ms, or torsades de pointes.
- Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening.
- Has uncontrolled Type-1 or Type-2 diabetes . A Subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject's diabetes is under control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PosiphenSolid oral dosage form, capsule | Drug | Posiphen, 10mg (Parkinson's Participants), Posiphen, 20mg (Parkinson's Participants), Posiphen, 40mg (Parkinson's Participants), Posiphen, 5mg (Parkinson's Participants), Posiphen, 80mg (Alzheimer's Participants), Posiphen, 80mg (Parkinson's Participants) |
| PlaceboSolid oral dosage form, capsule | Drug | Placebo (Alzheimer's Participants), Placebo (Parkinson's Participants) |
Primary outcome
Percentage of Participants With Treatment-Emergent Adverse Events
Time frame: 25±2 days
Percent of patients with AEs in the Posiphen treatment arms compared to the Placebo group
1 secondary outcome
Concentration of Posiphen in Plasma
Time frame: Samples collected over a 6 hour timeframe
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36641607Fang C, Hernandez P, Liow K, Damiano E, Zetterberg H, Blennow K, Feng D, Chen M, Maccecchini M. Buntanetap, a Novel Translational Inhibitor of Multiple Neurotoxic Proteins, Proves to Be Safe and Promising in Both Alzheimer's and Parkinson's Patients. J Prev Alzheimers Dis. 2023;10(1):25-33. doi: 10.14283/jpad.2022.84.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Posiphen in people with Alzheimer Disease and Parkinson Disease, run by Annovis Bio Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Treatment-Emergent Adverse Events (time frame: 25±2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04524351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.