Clinical trial NCT03835325: 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
Overall status: COMPLETED
Phase: NA
Conditions: Memory Disorders
Postmenopausal Symptoms
Keywords: Postmenopausal Symptoms, Memory Disorders
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks after the start of the treatment (Baseline)
Secondary outcomes:
measure: Change From Baseline in the Score of the Meta-memory in Adulthood Questionnaire - Portuguese Reduced Version
timeFrame: 12 weeks after the start of the treatment (Baseline)
measure: Change From Baseline in Stroop Test Victoria Version
timeFrame: 12 weeks after the start of the treatment
measure: The Overall Assessment of the Effectiveness of the Treatment by the Participant
timeFrame: 12 weeks after the start of the treatment
Other outcomes:
measure: Rate of Discontinuation of Treatment Due to Adverse Events.
timeFrame: 12 weeks after the start of the treatment
measure: Changes in Vital Signs (Blood Pressure) at the End of Treatment Compared to Baseline
timeFrame: 12 weeks after the start of the treatment
measure: Changes in Vital Signs (Heart Rate) at the End of Treatment Compared to Baseline
timeFrame: 12 weeks after the start of the treatment
measure: Changes in Vital Signs (Respiratory Rate) at the End of Treatment Compared to Baseline
timeFrame: 12 weeks after the start of the treatment
Locations:
city: São Paulo
country: Brazil
facility: CEPIC
state: SP
Study officials:
affiliation: Eurofarma Laboratorios S.A.
name: Cassiano O Berto
role: PRINCIPAL_INVESTIGATOR
References: