A Multicenter, Non-comparative, Phase IV Clinical Trial Evaluation of the Effect of Cogmax® in the Treatment of Memory Loss in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cogmax®
Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
干预措施: Cogmax® (Dietary Supplement)
结局指标
主要结局
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
时间窗: 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).
次要结局
- 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)