Cognitive Effects of a Dietary Supplement With PQQ, GABA, Caffeine, and B-Vitamins in Healthy Postmenopausal Women: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Function and Memory
• Intervention / Treatment: Dietary supplement: Placebo food supplement; Dietary supplement: Cortexium food supplement

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Szilvia Jager, PhD; Phone Number: 0036 203926655; Email: szilvia.jager@fempharma.hu

Study Locations

• Hungary
  • HB
    • Debrecen, HB, Hungary, 4032
      • Recruiting
      • Dr. Secret Private Clinic
      • Contact: Bence Kozma, MD PhD; Phone Number: 0036 703263596; Email: bence.kozma@med.unideb.hu
      • Principal Investigator: Bence Kozma, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participant will receive matching placebo supplement daily over a period of 6 weeks.	Dietary supplement: Placebo food supplement; Placebo food supplement is completely identical weight and outlook capsule to Cortexium, with 50% microcrystalline cellulose and 50% starch.
Experimental: Treatment; Participants will receive Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins).	Dietary supplement: Cortexium food supplement; Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 6 weeks.

Collaborators and Investigators

• Sponsor: FEMPHARMA Kft.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 31, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025CORTEXIUM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No