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

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.

Study Overview

• Status: Unknown
• Conditions: Memory Disorders; Postmenopausal Symptoms
• Intervention / Treatment: Dietary supplement: Cogmax®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassiano O Berto; Phone Number: +5511982712234; Email: cassiano.berto@eurofarma.com.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Recruiting
      • CEPIC
      • Contact: Vanessa Pádua; Email: vanessa.padua@cepic.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age ≥ 45 years and ≤ 60 years.
2. Memory loss associated with menopause.
3. 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).
4. Amenorrhea for at least 1 year and there is no more than 6 years.
5. Serum FSH dosage> 30mIU / mL.
6. Dosage of serum estradiol <20pg / mL.
7. Knowledge of the Portuguese language sufficient to answer the questionnaires.
8. Signature of the Free and Informed Consent Form (EHIC) prior to any study procedure.

Exclusion criteria:

Individuals who meet at least one of the following criteria will be excluded from the study:

1. Complaints of hot flashes, insomnia and / or very intense sleep disorders, at the discretion of the investigator.
2. Presence of moderate to severe depression, score ≥ 18 at assessment through the Beck Depression Inventory. ,
3. Presence of moderate to severe anxiety, with a ≥ 30 score on the Beck anxiety inventory. ,
4. Initiation of hormone replacement therapy in the 6 months prior to study inclusion. Patients receiving hormone replacement therapy starting more than 6 months before inclusion in the study may be included in the study provided that the treatment is regular with the same drug and the same dose during the last 6 months before inclusion and provided that this treatment is maintained throughout the study.
5. Use of psychotropic medications (anticonvulsants, benzodiazepines, antipsychotics), selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenaline reuptake inhibitors (SSRIs)
6. Alcoholism and / or use of other illicit drugs.
7. History of allergy or intolerance to any component of the experimental product formulation.
8. Diagnosis of neurological diseases associated with cognitive deficits (including dementia and mental retardation) or psychiatric illnesses.
9. Presence of serious or uncontrolled diseases (such as decompensated hypothyroidism) at the discretion of the researcher (such as stroke, Parkinson's disease, etc.).
10. 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.
11. Presence of any condition that, at the discretion of the researcher, makes the patient unfit to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cogmax®; Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.	Dietary supplement: Cogmax®; Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the score 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 short version of Meta-memory in Adulthood Questionnaire is composed of 39 multiple-choice statements that are answered in a five-point likert scale, evaluating seven factors of meta-memory (strategy, task, capacity, change, anxiety, achievement and locus). 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 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the score of the Meta-memory in Adulthood Questionnaire - Portuguese reduced version	The short version of Meta-memory in Adulthood Questionnaire is composed of 39 multiple-choice statements that are answered in a five-point likert scale, evaluating seven factors of meta-memory (strategy, task, capacity, change, anxiety, achievement and locus). Secondary Outcome Measures will evaluate the change from baseline of seven factors of meta-memory. The variation of the total sum obtained by means of the MIA questionnaire will be compared between all the visits in which the questionnaire was applied, ie, visit of selection (VS), visit 2 (V2) and final visit (VF).	12 weeks after the start of the treatment
Change from Baseline in Stroop Test Victoria version	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	The overall assessment of the effectiveness of the treatment by the participant, through multiple-choice statements in a five-point likert scale; My memory worsened in relation to the beginning of this treatment.; There has been no improvement in my memory, which remains the same as when I started this treatment.; My memory improved a little compared to how it was before the beginning treatment.; My memory improved a lot compared to how it was before the beginning of this treatment.; My memory returned to normal, that is, it returned to being as before the menopause.	12 weeks after the start of the treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of discontinuation of treatment due to adverse events.	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	Changes in vital signs (blood pressure) at the end of treatment compared to baseline The blood pressure will be analyzed by the variation of the values measured at each visit in relation to the baseline value (VR), which will be summarized by means of descriptive statistics according to the treatment group.	12 weeks after the start of the treatment
Changes in vital signs (heart rate) at the end of treatment compared to baseline	Changes in vital signs (heart rate) at the end of treatment compared to baseline The heart rate will be analyzed by the variation of the values measured at each visit in relation to the baseline value (VR), which will be summarized by means of descriptive statistics according to the treatment group.	12 weeks after the start of the treatment
Changes in vital signs (respiratory rate) at the end of treatment compared to baseline	Changes in vital signs (respiratory rate) at the end of treatment compared to baseline The respiratory rate will be analyzed by the variation of the values measured at each visit in relation to the baseline value (VR), which will be summarized by means of descriptive statistics according to the treatment group.	12 weeks after the start of the treatment

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Postmenopausal Symptoms, Memory Disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: EF152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No