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

NCT03835325 | Completed Results

• 1 other identifier: EF152
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Memory Disorders; Postmenopausal Symptoms

Keywords

Postmenopausal Symptoms, Memory Disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of the Score Number Relative to the Self-efficacy Factor, Consisting of Average Scores on the Domains Capacity, Control and Change of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version

  The primary outcome measure will evaluate the change from baseline in the score relative to the self-efficacy factor (SEF), consisting of arithmetic average on the domains capacity, control and change of the Meta-memory in Adulthood Questionnaire - Portuguese reduced version (MIAr) SEF final - SEF baseline ≤ 0 (no improvement in the measured memory capacity between the initial and final evaluations) SEF final - SEF baseline \> 0 (improvement in the memory capacity measured between the initial and final evaluations) The arithmetic average on the domains capacity, control and change range from 1 (worse) to 5 (better).

  12 weeks after the start of the treatment (Baseline)

Secondary Outcomes (3)

• Change From Baseline in the Score of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version

  12 weeks after the start of the treatment (Baseline)

• Change From Baseline in Stroop Test Victoria Version

  12 weeks after the start of the treatment

• The Overall Assessment of the Effectiveness of the Treatment by the Participant

  12 weeks after the start of the treatment

Other Outcomes (4)

• Rate of Discontinuation of Treatment Due to Adverse Events.

  12 weeks after the start of the treatment

• Changes in Vital Signs (Blood Pressure) at the End of Treatment Compared to Baseline

  12 weeks after the start of the treatment

• Changes in Vital Signs (Heart Rate) at the End of Treatment Compared to Baseline

  12 weeks after the start of the treatment

Study Arms (1)

Cogmax®

EXPERIMENTAL

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

Dietary Supplement: Cogmax®

Interventions

Cogmax® DIETARY_SUPPLEMENT

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

Cogmax®

Eligibility Criteria

• Age: 45 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 45 years and ≤ 60 years.
• Memory loss associated with menopause.
• Score ≤ 3.0 (mean value found in the elderly) related to the self-efficacy factor, consisting of the sum of the scores for the Capability, Control and Change domains obtained through the Metamemory in Adulthood Questionnaire - reduced version (MIAr).
• Amenorrhea for at least 1 year and there is no more than 6 years.
• Serum FSH dosage\> 30mIU / mL.
• Dosage of serum estradiol \<20pg / mL.
• Knowledge of the Portuguese language sufficient to answer the questionnaires.
• Signature of the Free and Informed Consent Form (EHIC) prior to any study procedure.

You may not qualify if:

• Individuals who meet at least one of the following criteria will be excluded from the study:
• Complaints of hot flashes, insomnia and / or very intense sleep disorders, at the discretion of the investigator.
• Presence of moderate to severe depression, score ≥ 18 at assessment through the Beck Depression Inventory. ,
• Presence of moderate to severe anxiety, with a ≥ 30 score on the Beck anxiety inventory. ,
• Use of psychotropic medications (anticonvulsants, benzodiazepines, antipsychotics), selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenaline reuptake inhibitors (SSRIs)
• Alcoholism and / or use of other illicit drugs.
• History of allergy or intolerance to any component of the experimental product formulation.
• Diagnosis of neurological diseases associated with cognitive deficits (including dementia and mental retardation) or psychiatric illnesses.
• Presence of serious or uncontrolled diseases (such as decompensated hypothyroidism) at the discretion of the researcher (such as stroke, Parkinson's disease, etc.).
• Participation in clinical research protocol in the previous 12 months unless, at the discretion of the researcher, their participation in the study may incur direct benefit to the research participant.
• Presence of any condition that, at the discretion of the researcher, makes the patient unfit to participate in the study.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

CEPIC

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sandra Rodrigues
• Organization: Eurofarma Laboratórios S.A

sandra.rodrigues@eurofarma.com.br

1150908600

Study Officials

• Cassiano O Berto

  Eurofarma Laboratorios S.A.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: February 8, 2019
• Study Start: January 23, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)