Back to resultsThe Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women
Primary Purpose
Memory Disorders, Postmenopausal Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cogmax®
Sponsored by
About this trial
This is an interventional treatment trial for Memory Disorders focused on measuring Postmenopausal Symptoms, Memory Disorders
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion criteria:
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. ,
- 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.
- 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.
Sites / Locations
- CEPICRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cogmax®
Arm Description
Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Change from Baseline in Stroop Test Victoria version
Change from Baseline in Stroop Test Victoria version
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.
Full Information
NCT ID
NCT03835325
First Posted
December 21, 2018
Last Updated
February 7, 2019
Sponsor
Eurofarma Laboratorios S.A.
1. Study Identification
Unique Protocol Identification Number
NCT03835325
Brief Title
The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women
Official Title
A Multicenter, Non-comparative, Phase IV Clinical Trial Evaluation of the Effect of Cogmax® in the Treatment of Memory Loss in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders, Postmenopausal Symptoms
Keywords
Postmenopausal Symptoms, Memory Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cogmax®
Arm Type
Experimental
Arm Description
Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cogmax®
Intervention Description
Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
12 weeks after the start of the treatment
Secondary Outcome Measure Information:
Title
Change from Baseline in the score of the Meta-memory in Adulthood Questionnaire - Portuguese reduced version
Description
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).
Time Frame
12 weeks after the start of the treatment
Title
Change from Baseline in Stroop Test Victoria version
Description
Change from Baseline in Stroop Test Victoria version
Time Frame
12 weeks after the start of the treatment
Title
The overall assessment of the effectiveness of the treatment by the participant
Description
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.
Time Frame
12 weeks after the start of the treatment
Other Pre-specified Outcome Measures:
Title
Rate of discontinuation of treatment due to adverse events.
Description
Rate of discontinuation of treatment due to adverse events.
Time Frame
12 weeks after the start of the treatment
Title
Changes in vital signs (blood pressure) at the end of treatment compared to baseline
Description
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.
Time Frame
12 weeks after the start of the treatment
Title
Changes in vital signs (heart rate) at the end of treatment compared to baseline
Description
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.
Time Frame
12 weeks after the start of the treatment
Title
Changes in vital signs (respiratory rate) at the end of treatment compared to baseline
Description
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.
Time Frame
12 weeks after the start of the treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion criteria:
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. ,
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassiano O Berto
Phone
+5511982712234
Email
cassiano.berto@eurofarma.com.br
Facility Information:
Facility Name
CEPIC
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Pádua
Email
vanessa.padua@cepic.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women
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