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

NCT06748989 | Recruiting

• 1 other identifier: 2025CORTEXIUM
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Central Nervous System-Vital Signs (CNS-VS)

  From enrollment to the end of treatment at 6 weeks.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participant will receive matching placebo supplement daily over a period of 6 weeks.

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).

Dietary Supplement: Cortexium food supplement

Interventions

Cortexium food supplement DIETARY_SUPPLEMENT

Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins).

Treatment

Placebo food supplement DIETARY_SUPPLEMENT

Placebo food supplement is completely identical weight and outlook capsule to Cortexium, with 50% microcrystalline cellulose and 50% starch.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FEMPHARMA Kft.: lead

Study Sites (1)

Dr. Secret Private Clinic

Debrecen, HB, 4032, Hungary

RECRUITING

Central Study Contacts

Szilvia Jager, PhD

CONTACT

0036 203926655; szilvia.jager@fempharma.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: May 20, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

HU (1)