Prostate CancerPhase 1NCT05375539

AGN-Cogni.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients

A Phase 1 study testing AGN-Cogni.Q in people with Prostate Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients. Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: AGN-Cogni.Q
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 2 May 2023to 15 Feb 2025
Phase: Phase 1
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 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Willingness and ability to give informed consent.
Agree to comply with all study procedures and attend all study visits to the best of their ability.
Male with age >=40 years.
History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if meet one or more of the below criteria:
Patients treated forprostate cancer and no detectable disease on imaging and clinical determination are eligible for enrollment, regardless of risk category.
Patients in the low-risk and favorable intermediate-risk groups who are not currently receiving any treatment or have declined any treatment.

Show all 17Show fewer

Not on concurrent androgen deprivation therapy.
ECOG performance status 0-2.
Life expectancy of greater than 12 months.
Subjects must have normal liver and kidney function as defined below:
a) total bilirubin within normal institutional limits,
b) AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal,
c) Creatinine within 1.5 ULN of institutional limits OR creatinine clearance > 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
d) Adequate bone marrow function (Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count (ANC) of ≥ 1.5 x 109/L), except for subjects with a history of chronic benign neutropenia, where an ANC of ≥ 1.0 x 109/L are eligible.
Subjects must agree to use two medically accepted method of contraception and must agree to continue use this method while on the trial and through at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception.
Subjects must stop the CYP3A4 and CYP2C19 strong inhibitors or inducers 2 weeks prior to the start of the study and during the study.
Subjects currently taking herbal supplements containing AGN extract, including CognI.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin must discontinue these or any other supplements containing these products 4 weeks prior to starting study drug.

Who cannot join

Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.
Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).
Subjects who are receiving any other investigational agents.
Uncontrolled intercurrent illness that would limit compliance with study requirements.
All vulnerable patient populations.
History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, any uncontrolled cardiac arrhythmia, or any other cardiac related problem that would be considered a contraindication for participation in the opinion of the treating physician.
Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens.
Subjects who are taking Warfarin/Coumadin.

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State Cancer Institute
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Angelica Herbal Supplement AGN-Cogni.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)

This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients.

Read the detailed description

The long-term goal of the study is to conduct human clinical trials to test Angelica gigas Nakai (AGN) root alcoholic extract herbal supplement product (AGN-Cogni.Q, or Cogni.QTM, made with INM®176 proprietary ingredient, Quality of Life Laboratories, Purchase, NY) as a safe and potential efficacious modality for prostate cancer interception akin to secondary prevention to delay hormonal therapy or avoid it entirely after patients have developed recurrent disease following their standard of care (SOC) surgery and radiation curative treatment. The acute dose safety and pharmacokinetics (PK) and pharmacodynamics (PD) information in the target patient population from the current proposed acute PK dose-response trial will inform the optimal design and execution of the longer-term safety and efficacy (phase I/II) trials.

Conditions: Prostate Cancer
Being tested: AGN-Cogni.Q
Keywords: Angelica gigas Nakai, INM 176, pharmacokinetics
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGN-Cogni.QDrug
Also called INM®176
Herbal dietary supplement products containing/based on AGN alcoholic extracts (including CognI.Q; Decursinol-50TM, GWB78®, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) are marketed in the US for memory enhancement, pain relief and for women's post-menopausal symptom management.

Study groups in NCT05375539
Study group	Role	What they receive
AGN-Cogni.Q	Experimental	Dose level +1 (800 mg, 4 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Receives: Drug: AGN-Cogni.Q

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Safety Via Electrocardiography (EKG)
Evaluation of cardiac rhythm and repolarization using 12-lead EKG to identify any treatment-emergent abnormalities. Unit of Measure: Number of participants with treatment-emergent EKG abnormalities.
Measured: Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).
Safety Blood Laboratory Tests
Evaluation of hematological and metabolic safety via Complete Blood Count (CBC) with differential, Comprehensive Metabolic Panel (CMP), and coagulation tests (INR, PT, PTT) to identify any treatment-emergent abnormalities.
Measured: 24 hours post-dose and prior to each subsequent dose level (Up to 5 weeks).

Secondary outcomes (5)

Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
To determine the Cmax for decursin (D), decursinol angelate (DA), and their metabolite decursinol (DOH) following a single dose. Peak concentration is estimated from blood samples collected at 0, 2, 3, 4, 5, 6, 7, and 24 hours post-dose.
Measured: 0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)
Plasma Concentration Versus Time Curve (AUC)
Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24h) for decursin (D), decursinol angelate (DA), and their metabolite decursinol (DOH). AUC is calculated using the trapezoidal rule from blood samples collected at 0, 2, 3, 4, 5, 6, 7, and 24 hours post-dose.
Measured: 0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
The percentage of specific immune cell populations (NK cells, CD4+ T cells, and CD8+ T cells) within the total lymphocyte pool was measured using flow cytometric quantitation. Change is evaluated by comparing blood samples taken at Baseline (0h) to Day 2 (24 hours ± 2 hours) following administration of each AGN-CognI.Q dose.
Measured: Baseline (0 hours) and Day 2 (24 hours post-dose).
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
Body temperature was recorded to monitor safety and physiological response. Measurements were taken via tympanic thermometer at baseline (0 hours) and at 2, 3, 4, 5, 6, 7 and 24 hours (±2 hours) following the administration of each AGN-CognI.Q dose.
Measured: Baseline (0 hours) and 24 hours post-dose.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Evaluation of clinical safety and toxicity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From first dose of study drug to 4 weeks (± 7 days) following the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 202315 Feb 2025

First posted16 May 2022
Study start2 May 2023
Primary completion15 Feb 2025
Study completion15 Feb 2025

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.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: After the first subject is enrolled, a 14-day waiting period must occur between each subject before the next subject can be enrolled and dosed. If one subject develops a DLT at any dose level, that subject will cease treatment but will continue safety assessments follow-ups. If a second subject develops a DLT at the same dose level, the trial will be stopped and the dose level below will be the MTD. Any subjects who are at higher dose level at the time of 2nd DLT occurrence, will also stop with no further escalation. All subjects will start at the 800 mg dose (visit 2). Each subject will continue to the next week's dose until a DLT has been reached. However, if 2 DLTs occur at the starting 800 mg dose level, trial will be suspended.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05375539
Sponsor's protocol ID: PSCI-21-173
Other IDs: R01CA260901
Status last verified: May 2026
First submitted: 5 May 2022
Last updated: 2 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All research materials and data, generated by this grant, will be distributed freely or deposited into a repository/stock center making them available to the broader scientific community, either before or immediately after publication.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Angelica Herbal Supplement AGN-Cogni.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)
ClinicalTrials.gov ID: NCT05375539
Acronym / sponsor ID: PSCI-21-173
Conditions: Prostate Cancer
Keywords: Angelica gigas Nakai, INM 176, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 2 May 2023 (actual)
Primary completion: 15 Feb 2025 (actual)
Study completion: 15 Feb 2025 (actual)
First posted: 16 May 2022 (actual)
Results: Posted 6 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: After the first subject is enrolled, a 14-day waiting period must occur between each subject before the next subject can be enrolled and dosed. If one subject develops a DLT at any dose level, that subject will cease treatment but will continue safety assessments follow-ups. If a second subject develops a DLT at the same dose level, the trial will be stopped and the dose level below will be the MTD. Any subjects who are at higher dose level at the time of 2nd DLT occurrence, will also stop with no further escalation. All subjects will start at the 800 mg dose (visit 2). Each subject will continue to the next week's dose until a DLT has been reached. However, if 2 DLTs occur at the starting 800 mg dose level, trial will be suspended.

Arm	Type	Receives
AGN-Cogni.Q	Experimental	Drug: AGN-Cogni.QDose level +1 (800 mg, 4 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after)

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Willingness and ability to give informed consent.
Agree to comply with all study procedures and attend all study visits to the best of their ability.
Male with age >=40 years.
History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if meet one or more of the below criteria:
Not on concurrent androgen deprivation therapy.

Key exclusion criteria (8 listed)

Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.
Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).
Subjects who are receiving any other investigational agents.
Uncontrolled intercurrent illness that would limit compliance with study requirements.
All vulnerable patient populations.

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
AGN-Cogni.QAlso: INM®176Herbal dietary supplement products containing/based on AGN alcoholic extracts (including CognI.Q; Decursinol-50TM, GWB78®, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) are marketed in the US for memory enhancement, pain relief and for women's post-menopausal symptom management.	Drug	AGN-Cogni.Q

Primary outcome

Cardiac Safety Via Electrocardiography (EKG)
Time frame: Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).
Evaluation of cardiac rhythm and repolarization using 12-lead EKG to identify any treatment-emergent abnormalities. Unit of Measure: Number of participants with treatment-emergent EKG abnormalities.
Safety Blood Laboratory Tests
Time frame: 24 hours post-dose and prior to each subsequent dose level (Up to 5 weeks).
Evaluation of hematological and metabolic safety via Complete Blood Count (CBC) with differential, Comprehensive Metabolic Panel (CMP), and coagulation tests (INR, PT, PTT) to identify any treatment-emergent abnormalities.

5 secondary outcomes

Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Time frame: 0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)
Plasma Concentration Versus Time Curve (AUC)
Time frame: 0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
Time frame: Baseline (0 hours) and Day 2 (24 hours post-dose).
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
Time frame: Baseline (0 hours) and 24 hours post-dose.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug to 4 weeks (± 7 days) following the last dose.

Results and safety

Results posted to the registry on 6 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AGN-CognI.Q	12	12

Primary outcome: Cardiac Safety Via Electrocardiography (EKG)

Time frame: Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).. Count of participants. Unit: Participants

Measure	AGN-CognI.Q 800 mg n = 12	AGN-CognI.Q 1200 mg n = 10	AGN-CognI.Q 1600 mg n = 10	AGN-CognI.Q 2000 mg n = 5
Participants with ≥1 treatment-emergent EKG abnormality	0	0	0	1
Participants with no treatment-emergent EKG abnormality	12	10	10	4

Population analysed: This was a sequential within-subject dose-escalation study. Arms are defined by dose level. Participants could contribute data to multiple arms due to the within-subject dose-escalation design.

Primary outcome: Safety Blood Laboratory Tests

Time frame: 24 hours post-dose and prior to each subsequent dose level (Up to 5 weeks).. Count of participants. Unit: Participants

Measure	AGN-CognI.Q 800 mg n = 12	AGN-CognI.Q 1200 mg n = 10	AGN-CognI.Q 1600 mg n = 10	AGN-CognI.Q 2000 mg n = 5
Participants with Coagulation abnormalities (INR/aPTT)	1	1	0	0
Participants with Metabolic abnormalities (Hypokalemia)	1	1	0	0

Population analysed: This was a single-arm sequential dose-escalation study. Participants received escalating single doses of AGN-CognI.Q (800 mg, 1200 mg, 1600 mg, and 2000 mg). Outcome measures were summarized across all dose levels because the same participants could contribute data at multiple dose levels.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AGN-Cogni.Q 800 mg	0 of 12 (0%)	3 of 12 (25%)	0 of 12
AGN-CognI.Q 1200 mg	0 of 10 (0%)	4 of 10 (40%)	0 of 10
AGN-CognI.Q 1600 mg	0 of 10 (0%)	2 of 10 (20%)	0 of 10
AGN-CognI.Q 2000 mg	0 of 5 (0%)	2 of 5 (40%)	0 of 5

Limitations and caveats (from the sponsor): The second participant of the trial experienced an herbal-drug adverse interaction at the first dose of AGN-Cogni.Q (800 mg) with warfarin (7.5 mg) anti-coagulant maintenance medication, leading to increased bleeding risk as measured by PT/INR (from 2 to 8). Persons taken warfarin blood thinner drug should not take AGN supplement to avoid this bleeding risk.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All research materials and data, generated by this grant, will be distributed freely or deposited into a repository/stock center making them available to the broader scientific community, either before or immediately after publication.

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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.

Monika Joshi, MD principal investigator

Penn State Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AGN-Cogni.Q in people with Prostate Cancer, run by Milton S. Hershey Medical Center at 1 site 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 17 inclusion and 8 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 6 May 2026). 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?

Cardiac Safety Via Electrocardiography (EKG) (time frame: Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).). The study lists 2 primary outcomes in all. 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 NCT05375539.

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 2 Jun 2026.