Cognitive Function and MemoryNCT06748989
Cognitive Effects of a Dietary Supplement With PQQ, GABA, Caffeine, and B-Vitamins in Healthy Postmenopausal Women: A Randomized Controlled Trial
A study testing Cortexium food supplement in people with Cognitive Function and Memory, run by FEMPHARMA Kft. at 1 site in Hungary.
Trial summary
Various food supplements have been shown to improve cognitive function. However, there is limited data on the impact of these supplements on postmenopausal women. Millions of women experience difficulty with concentration, and memory lapses during menopause. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function and Memory
- What is being tested?
- Cortexium food supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteHungary
- Study dates
- 20 May 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health.
- Education level at least completed elementary.
- Menopausal status with minimum 1 year from the last menstrual period and based on the criterion of follicle-stimulating hormone (FSH) level (FSH > 30 mlU/ml) or a history of bilateral oophorectomy.
Who cannot join
- Active cancerous disease within the period of 5 years before recruitment.
- Mental diseases in medical history, including depression.
- Addiction to drugs and alcohol.
- Symptoms of dementia or history of neurological treatment or neurocognitive disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Specially Formulated Dietary Supplement With Pyrroloquinoline Quinone, γ-aminobutyric Acid, Caffeine and B-vitamins on Cognitive Function in Healthy Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study
Various food supplements have been shown to improve cognitive function. However, there is limited data on the impact of these supplements on postmenopausal women. Millions of women experience difficulty with concentration, and memory lapses during menopause. Research shows that up to 60% of women report cognitive changes related to menopause, severely impacting their quality of life and professional performance. Women are significantly more likely to develop dementia and other cognitive dysfunction. The specially formulated Cortexium with four key ingredients aims to support cognitive function in women:
- PQQ (Pyrroloquinoline Quinone) is a redox coenzyme with high antioxidant potential and is considered to affect the brain function by increasing mitochondrial production and activation, nerve cell protection, and enhanced production of nerve growth factor.
- GABA (gamma-aminobutyric acid) is an important neurotransmitter that helps induce calm and relaxation in the brain. Its positive effects include reducing stress and anxiety, which promotes mental clarity and concentration, thus enhancing mental performance. Additionally, it can help combat fatigue by supporting restful sleep, which, in the long term, boosts brain function efficiency.
- B-VITAMINS (B1, B2, B3, B5, B6, B7, B9, B12) are essential for brain function and energy production. They support the synthesis of neurotransmitters that improve mood, memory, and concentration, and help combat stress and mental fatigue. Together, they contribute to protecting brain cells and maintaining cognitive performance.
- CAFFEINE: The stimulating and invigorating effects of caffeine on the brain and nervous system have been known for centuries. Caffeine is a mild psychostimulant with invigorating effects. It also alleviates symptoms of fatigue and enhances work capacity. Moreover, moderate amounts of caffeine are known to have a stimulating effect on the cerebrocortical fields responsible for thinking: it enhances mental activity, improves cognitive functions, and accelerates mental associations. In this way, caffeine's stimulating effect can also lead to an improved sense of well-being Our aim is test the hypothesis that Cortexium dietary supplement improves cognitive function in postmenopausal women.
- Conditions
- Cognitive Function and Memory
- Being tested
- Cortexium food supplement, Placebo food supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortexium food supplementDietary supplement
Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins).
Placebo food supplementDietary supplement
Placebo food supplement is completely identical weight and outlook capsule to Cortexium, with 50% microcrystalline cellulose and 50% starch.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participant will receive matching placebo supplement daily over a period of 6 weeks. Receives: Dietary Supplement: Placebo food supplement |
| Treatment | Experimental | Participants will receive Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins). Receives: Dietary Supplement: Cortexium food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognition Index (NCI)
Neurocognition Index (NCI) as calculated by Cognitive functions using the diagnostic instrument Central Nervous System-Vital Signs (CNS-VS) computerized neuropsychological / neurocognitive test.
Measured: From enrollment to the end of treatment at 6 weeks.
Secondary outcomes (1)
Central Nervous System-Vital Signs (CNS-VS)
Central Nervous System-Vital Signs (CNS-VS) 11 items of the cognitive function domain score (composite memory, verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, simple attention, and motor speed).
Measured: From enrollment to the end of treatment at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 May 2025
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function and MemoryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- FEMPHARMA Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748989
- Sponsor's protocol ID
- 2025CORTEXIUM
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Specially Formulated Dietary Supplement With Pyrroloquinoline Quinone, γ-aminobutyric Acid, Caffeine and B-vitamins on Cognitive Function in Healthy Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06748989
- Acronym / sponsor ID
- 2025CORTEXIUM
- Conditions
- Cognitive Function and Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- FEMPHARMA Kft.Industry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Various food supplements have been shown to improve cognitive function. However, there is limited data on the impact of these supplements on postmenopausal women. Millions of women experience difficulty with concentration, and memory lapses during menopause. Research shows that up to 60% of women report cognitive changes related to menopause, severely impacting their quality of life and professional performance. Women are significantly more likely to develop dementia and other cognitive dysfunction. The specially formulated Cortexium with four key ingredients aims to support cognitive function in women:
- PQQ (Pyrroloquinoline Quinone) is a redox coenzyme with high antioxidant potential and is considered to affect the brain function by increasing mitochondrial production and activation, nerve cell protection, and enhanced production of nerve growth factor.
- GABA (gamma-aminobutyric acid) is an important neurotransmitter that helps induce calm and relaxation in the brain. Its positive effects include reducing stress and anxiety, which promotes mental clarity and concentration, thus enhancing mental performance. Additionally, it can help combat fatigue by supporting restful sleep, which, in the long term, boosts brain function efficiency.
- B-VITAMINS (B1, B2, B3, B5, B6, B7, B9, B12) are essential for brain function and energy production. They support the synthesis of neurotransmitters that improve mood, memory, and concentration, and help combat stress and mental fatigue. Together, they contribute to protecting brain cells and maintaining cognitive performance.
- CAFFEINE: The stimulating and invigorating effects of caffeine on the brain and nervous system have been known for centuries. Caffeine is a mild psychostimulant with invigorating effects. It also alleviates symptoms of fatigue and enhances work capacity. Moreover, moderate amounts of caffeine are known to have a stimulating effect on the cerebrocortical fields responsible for thinking: it enhances mental activity, improves cognitive functions, and accelerates mental associations. In this way, caffeine's stimulating effect can also lead to an improved sense of well-being Our aim is test the hypothesis that Cortexium dietary supplement improves cognitive function in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo food supplementParticipant will receive matching placebo supplement daily over a period of 6 weeks. |
| Treatment | Experimental | Dietary Supplement: Cortexium food supplementParticipants will receive Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Good general health.
- Education level at least completed elementary.
- Menopausal status with minimum 1 year from the last menstrual period and based on the criterion of follicle-stimulating hormone (FSH) level (FSH > 30 mlU/ml) or a history of bilateral oophorectomy.
Key exclusion criteria (4 listed)
- Active cancerous disease within the period of 5 years before recruitment.
- Mental diseases in medical history, including depression.
- Addiction to drugs and alcohol.
- Symptoms of dementia or history of neurological treatment or neurocognitive disorder.
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 |
|---|---|---|
| Cortexium food supplementCortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins). | Dietary supplement | Treatment |
| Placebo food supplementPlacebo food supplement is completely identical weight and outlook capsule to Cortexium, with 50% microcrystalline cellulose and 50% starch. | Dietary supplement | Placebo |
Primary outcome
Neurocognition Index (NCI)
Time frame: From enrollment to the end of treatment at 6 weeks.
Neurocognition Index (NCI) as calculated by Cognitive functions using the diagnostic instrument Central Nervous System-Vital Signs (CNS-VS) computerized neuropsychological / neurocognitive test.
1 secondary outcome
Central Nervous System-Vital Signs (CNS-VS)
Time frame: From enrollment to the end of treatment at 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortexium food supplement in people with Cognitive Function and Memory, run by FEMPHARMA Kft. at 1 site in Hungary.
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 3 inclusion and 4 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 Sep 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 Hungary. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurocognition Index (NCI) (time frame: From enrollment to the end of treatment at 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.