Memory DisordersNCT03835325
The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women
A study testing Cogmax® in people with Memory Disorders and Postmenopausal Symptoms, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Memory Disorders, Postmenopausal Symptoms
- What is being tested?
- Cogmax®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jan 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Memory Disorders, Postmenopausal Symptoms
- Being tested
- Cogmax®
- Keywords
- Postmenopausal Symptoms, Memory Disorders
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmax®Dietary supplement
Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cogmax® | Experimental | Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks. Receives: Dietary Supplement: Cogmax® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 12 weeks after the start of the treatment (Baseline)
Secondary outcomes (3)
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).
Measured: 12 weeks after the start of the treatment (Baseline)
Change From Baseline in Stroop Test Victoria Version
Change from Baseline in Stroop Test Victoria version
Measured: 12 weeks after the start of the treatment
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.
Measured: 12 weeks after the start of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start23 Jan 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cassiano O Berto, Principal investigator, Eurofarma Laboratorios S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835325
- Sponsor's protocol ID
- EF152
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2018
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03835325
- Acronym / sponsor ID
- EF152
- Conditions
- Memory Disorders, Postmenopausal Symptoms
- Keywords
- Postmenopausal Symptoms, Memory Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cogmax® | Experimental | Dietary Supplement: Cogmax®Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogmax®Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks. | Dietary supplement | Cogmax® |
Primary outcome
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).
3 secondary outcomes
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 (Baseline)
Change From Baseline in Stroop Test Victoria Version
Time frame: 12 weeks after the start of the treatment
The Overall Assessment of the Effectiveness of the Treatment by the Participant
Time frame: 12 weeks after the start of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Memory Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassiano O Berto principal investigator
Eurofarma Laboratorios S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmax® in people with Memory Disorders and Postmenopausal Symptoms, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 weeks after the start of the treatment (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.