NCT03835325

The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women

A Multicenter, Non-comparative, Phase IV Clinical Trial Evaluation of the Effect of Cogmax® in the Treatment of Memory Loss in Postmenopausal Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Complaints about memory loss are very common in women in the menopausal transition period. The effectiveness of estrogen replacement therapy in cognitive improvement is controversial. Partial positive results were obtained in some studies with regard to memory improvement, so far no standard treatment considered effective in these cases. Effective pharmacological approaches to the treatment of memory loss associated with menopause are an unmet medical need. Cogmax® is a multivitamin and mineral supplement that contains numerous key elements for cognitive function, and may be a safe therapeutic option in these cases. The multicenter, non-comparative (single-arm) phase IV clinical trial will be conducted with 80 female participants aged 45 to 60 years and menopausal memory loss complaint. After 3 months of using multivitamin and mineral supplement, memory and attention will be reevaluated through specific questionnaire and the Stroop Test Victoria version.

Detailed description

This multicenter, non-comparative phase IV clinical trial will be conducted at brazilian clinical trial centers under the auspices of Eurofarma Laboratories S.A. Recruitment for the study will begin after the relevant ethical and regulatory approvals and will have an estimated duration of 4 months. The study will include 80 female participants aged between 45 and 60 years and menopausal memory complaints who consent to participate in the study by signing the informed consent form. To be included, participants must meet all inclusion criteria and none of the exclusion criteria. Each participant will initially complete a selection period with a maximum duration of 14 days for evaluation of eligibility. Participants will then be treated with Cogmax® in the dosage of two capsules per day for 12 weeks.

Conditions

• Memory Disorders
• Postmenopausal Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cogmax®	Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.

Timeline

• Start date: 2019-01-23
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2019-02-08
• Last updated: 2025-04-15
• Results posted: 2025-04-15

Locations

1 site across 1 country: Brazil