<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835325</url>
  </required_header>
  <id_info>
    <org_study_id>EF152</org_study_id>
    <nct_id>NCT03835325</nct_id>
  </id_info>
  <brief_title>The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eurofarma Laboratorios S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eurofarma Laboratorios S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Complaints about memory loss are very common in women in the menopausal transition period.&#xD;
      The effectiveness of estrogen replacement therapy in cognitive improvement is controversial.&#xD;
      Partial positive results were obtained in some studies with regard to memory improvement, so&#xD;
      far no standard treatment considered effective in these cases. Effective pharmacological&#xD;
      approaches to the treatment of memory loss associated with menopause are an unmet medical&#xD;
      need. Cogmax® is a multivitamin and mineral supplement that contains numerous key elements&#xD;
      for cognitive function, and may be a safe therapeutic option in these cases.&#xD;
&#xD;
      The multicenter, non-comparative (single-arm) phase IV clinical trial will be conducted with&#xD;
      80 female participants aged 45 to 60 years and menopausal memory loss complaint.&#xD;
&#xD;
      After 3 months of using multivitamin and mineral supplement, memory and attention will be&#xD;
      reevaluated through specific questionnaire and the Stroop Test Victoria version.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter, non-comparative phase IV clinical trial will be conducted at brazilian&#xD;
      clinical trial centers under the auspices of Eurofarma Laboratories S.A. Recruitment for the&#xD;
      study will begin after the relevant ethical and regulatory approvals and will have an&#xD;
      estimated duration of 4 months.&#xD;
&#xD;
      The study will include 80 female participants aged between 45 and 60 years and menopausal&#xD;
      memory complaints who consent to participate in the study by signing the informed consent&#xD;
      form.&#xD;
&#xD;
      To be included, participants must meet all inclusion criteria and none of the exclusion&#xD;
      criteria. Each participant will initially complete a selection period with a maximum duration&#xD;
      of 14 days for evaluation of eligibility. Participants will then be treated with Cogmax® in&#xD;
      the dosage of two capsules per day for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <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).&#xD;
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 &gt; 0 (improvement in the memory capacity measured between the initial and final evaluations)&#xD;
The arithmetic average on the domains capacity, control and change range from 1 (worse) to 5 (better).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the score of the Meta-memory in Adulthood Questionnaire - Portuguese reduced version</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <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).&#xD;
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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Stroop Test Victoria version</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <description>Change from Baseline in Stroop Test Victoria version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The overall assessment of the effectiveness of the treatment by the participant</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <description>The overall assessment of the effectiveness of the treatment by the participant, through multiple-choice statements in a five-point likert scale&#xD;
My memory worsened in relation to the beginning of this treatment.&#xD;
There has been no improvement in my memory, which remains the same as when I started this treatment.&#xD;
My memory improved a little compared to how it was before the beginning treatment.&#xD;
My memory improved a lot compared to how it was before the beginning of this treatment.&#xD;
My memory returned to normal, that is, it returned to being as before the menopause.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of discontinuation of treatment due to adverse events.</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <description>Rate of discontinuation of treatment due to adverse events.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in vital signs (blood pressure) at the end of treatment compared to baseline</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <description>Changes in vital signs (blood pressure) at the end of treatment compared to baseline&#xD;
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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in vital signs (heart rate) at the end of treatment compared to baseline</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <description>Changes in vital signs (heart rate) at the end of treatment compared to baseline&#xD;
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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in vital signs (respiratory rate) at the end of treatment compared to baseline</measure>
    <time_frame>12 weeks after the start of the treatment</time_frame>
    <description>Changes in vital signs (respiratory rate) at the end of treatment compared to baseline&#xD;
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.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Memory Disorders</condition>
  <condition>Postmenopausal Symptoms</condition>
  <arm_group>
    <arm_group_label>Cogmax®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cogmax®</intervention_name>
    <description>Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.</description>
    <arm_group_label>Cogmax®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 45 years and ≤ 60 years.&#xD;
&#xD;
          2. Memory loss associated with menopause.&#xD;
&#xD;
          3. Score ≤ 3.0 (mean value found in the elderly) related to the self-efficacy factor,&#xD;
             consisting of the sum of the scores for the Capability, Control and Change domains&#xD;
             obtained through the Metamemory in Adulthood Questionnaire - reduced version (MIAr).&#xD;
&#xD;
          4. Amenorrhea for at least 1 year and there is no more than 6 years.&#xD;
&#xD;
          5. Serum FSH dosage&gt; 30mIU / mL.&#xD;
&#xD;
          6. Dosage of serum estradiol &lt;20pg / mL.&#xD;
&#xD;
          7. Knowledge of the Portuguese language sufficient to answer the questionnaires.&#xD;
&#xD;
          8. Signature of the Free and Informed Consent Form (EHIC) prior to any study procedure.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Individuals who meet at least one of the following criteria will be excluded from the&#xD;
        study:&#xD;
&#xD;
          1. Complaints of hot flashes, insomnia and / or very intense sleep disorders, at the&#xD;
             discretion of the investigator.&#xD;
&#xD;
          2. Presence of moderate to severe depression, score ≥ 18 at assessment through the Beck&#xD;
             Depression Inventory. ,&#xD;
&#xD;
          3. Presence of moderate to severe anxiety, with a ≥ 30 score on the Beck anxiety&#xD;
             inventory. ,&#xD;
&#xD;
          4. Initiation of hormone replacement therapy in the 6 months prior to study inclusion.&#xD;
             Patients receiving hormone replacement therapy starting more than 6 months before&#xD;
             inclusion in the study may be included in the study provided that the treatment is&#xD;
             regular with the same drug and the same dose during the last 6 months before inclusion&#xD;
             and provided that this treatment is maintained throughout the study.&#xD;
&#xD;
          5. Use of psychotropic medications (anticonvulsants, benzodiazepines, antipsychotics),&#xD;
             selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and&#xD;
             noradrenaline reuptake inhibitors (SSRIs)&#xD;
&#xD;
          6. Alcoholism and / or use of other illicit drugs.&#xD;
&#xD;
          7. History of allergy or intolerance to any component of the experimental product&#xD;
             formulation.&#xD;
&#xD;
          8. Diagnosis of neurological diseases associated with cognitive deficits (including&#xD;
             dementia and mental retardation) or psychiatric illnesses.&#xD;
&#xD;
          9. Presence of serious or uncontrolled diseases (such as decompensated hypothyroidism) at&#xD;
             the discretion of the researcher (such as stroke, Parkinson's disease, etc.).&#xD;
&#xD;
         10. Participation in clinical research protocol in the previous 12 months unless, at the&#xD;
             discretion of the researcher, their participation in the study may incur direct&#xD;
             benefit to the research participant.&#xD;
&#xD;
         11. Presence of any condition that, at the discretion of the researcher, makes the patient&#xD;
             unfit to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cassiano O Berto</last_name>
    <phone>+5511982712234</phone>
    <email>cassiano.berto@eurofarma.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>CEPIC</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanessa Pádua</last_name>
      <email>vanessa.padua@cepic.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postmenopausal Symptoms, Memory Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memory Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 10, 2021</submitted>
    <returned>March 30, 2021</returned>
    <submitted>May 31, 2022</submitted>
    <returned>March 9, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835325
org study id: EF152
nct id: NCT03835325
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
time frame: 12 weeks after the start of the treatment
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).
measure: Change from Baseline in the score of the Meta-memory in Adulthood Questionnaire - Portuguese reduced version
time frame: 12 weeks after the start of the treatment
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).
measure: Change from Baseline in Stroop Test Victoria version
time frame: 12 weeks after the start of the treatment
description: Change from Baseline in Stroop Test Victoria version
measure: The overall assessment of the effectiveness of the treatment by the participant
time frame: 12 weeks after the start of the treatment
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.
measure: Rate of discontinuation of treatment due to adverse events.
time frame: 12 weeks after the start of the treatment
description: Rate of discontinuation of treatment due to adverse events.
measure: Changes in vital signs (blood pressure) at the end of treatment compared to baseline
time frame: 12 weeks after the start of the treatment
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.
measure: Changes in vital signs (heart rate) at the end of treatment compared to baseline
time frame: 12 weeks after the start of the treatment
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.
measure: Changes in vital signs (respiratory rate) at the end of treatment compared to baseline
time frame: 12 weeks after the start of the treatment
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.
arm group label: Cogmax®
arm group type: Experimental
description: Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
intervention type: Dietary Supplement
intervention name: Cogmax®
description: Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
arm group label: Cogmax®
criteria: 
gender: Female
gender based: Yes
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cassiano O Berto
phone: +5511982712234
email: cassiano.berto@eurofarma.com.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Memory Disorders
sharing ipd: No
submitted: March 10, 2021
returned: March 30, 2021
submitted: May 31, 2022
returned: March 9, 2023