A Multicenter, Non-comparative, Phase IV Clinical Trial Evaluation of the Effect of Cogmax® in the Treatment of Memory Loss in Postmenopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Memory Disorders
- Sponsor
- Eurofarma Laboratorios S.A.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: 12 weeks after the start of the treatment (Baseline)
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).
Secondary Outcomes
- Change From Baseline in Stroop Test Victoria Version(12 weeks after the start of the treatment)
- 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))
- The Overall Assessment of the Effectiveness of the Treatment by the Participant(12 weeks after the start of the treatment)