Trial Outcomes & Findings for The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women (NCT NCT03835325)

NCT ID: NCT03835325

Last Updated: 2025-04-15

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 12 weeks after the start of the treatment (Baseline)
• Results posted on: 2025-04-15

Participant Flow

Beginning of the study: 01/28/2019 (first visit of the first participant) End of study: 12/09/2019 (last visit of the last participant) Recruitment´s type of location: Medical clinic

Inclusion criteria, exclusion criteria and other reasons

Participant milestones

Measure	Cogmax® Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks. Cogmax®: Research participants received 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
Overall Study STARTED	80
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Cogmax® Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks. Cogmax®: Research participants received 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
Overall Study Lack of adherence to protocol procedures	1
Overall Study Selection failure	1

Baseline Characteristics

Efficacy analyzes were performed for the population with modified treatment intent (mITT, n=78)

Baseline characteristics by cohort

Measure	Cogmax® n=80 Participants Cogmax®: Research participants received 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
Age, Categorical <=18 years	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=80 Participants
Age, Categorical >=65 years	0 Participants n=80 Participants
Sex: Female, Male Female	80 Participants n=80 Participants
Sex: Female, Male Male	0 Participants n=80 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=80 Participants
Race (NIH/OMB) Asian	23 Participants n=80 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=80 Participants
Race (NIH/OMB) Black or African American	4 Participants n=80 Participants
Race (NIH/OMB) White	53 Participants n=80 Participants
Race (NIH/OMB) More than one race	0 Participants n=80 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=80 Participants
Vital signs Systolic arterial pressure	125.0 mmHg STANDARD_DEVIATION 15.1 • n=80 Participants
Vital signs Diastolic arterial pressure	77.4 mmHg STANDARD_DEVIATION 10.0 • n=80 Participants
Heart rate	69.2 bpm STANDARD_DEVIATION 10.6 • n=80 Participants
respiratory rate	16.6 breaths per minute STANDARD_DEVIATION 1.4 • n=80 Participants
SELF-EFFICACY Factor mITT population	2.5 Score STANDARD_DEVIATION 0.3 • n=78 Participants • Efficacy analyzes were performed for the population with modified treatment intent (mITT, n=78)
SELF-EFFICACY Factor PP population	2.5 Score STANDARD_DEVIATION 0.3 • n=80 Participants • Efficacy analyzes were performed for the population with modified treatment intent (mITT, n=78)

PRIMARY outcome

Timeframe: 12 weeks after the start of the treatment (Baseline)

Population: mITT and PP. Efficacy analyzes were performed for the population with modified treatment intent (mITT, n=78)

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).

Outcome measures

Measure	Cogmax® n=80 Participants Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks. Cogmax®: Research participants received 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
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 mITT	2.9 score on a scale Standard Deviation 0.5
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 PP	2.9 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 12 weeks after the start of the treatment (Baseline)

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks after the start of the treatment

Change from Baseline in Stroop Test Victoria version

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks after the start of the treatment

The overall assessment of the effectiveness of the treatment by the participant, through multiple-choice statements in a five-point likert scale

1. My memory worsened in relation to the beginning of this treatment.

2. There has been no improvement in my memory, which remains the same as when I started this treatment.

3. My memory improved a little compared to how it was before the beginning treatment.

4. My memory improved a lot compared to how it was before the beginning of this treatment.

5. My memory returned to normal, that is, it returned to being as before the menopause.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after the start of the treatment

Rate of discontinuation of treatment due to adverse events.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after the start of the treatment

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after the start of the treatment

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after the start of the treatment

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.

Outcome measures

Outcome data not reported

Adverse Events

Cogmax®

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cogmax® n=80 participants at risk Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks. Cogmax®: Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
Infections and infestations Gingivitis, Nasopharyngitis and Respiratory tract infection	2.5% 2/80 • Number of events 3 • 12 weeks
Vascular disorders Vascular disorders	31.2% 25/80 • Number of events 26 • 12 weeks
Metabolism and nutrition disorders Metabolism and nutrition disorders	26.2% 21/80 • Number of events 37 • 12 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	22.5% 18/80 • Number of events 29 • 12 weeks
Endocrine disorders Endocrine disorders	10.0% 8/80 • Number of events 8 • 12 weeks
Gastrointestinal disorders Gastrointestinal disorders	10.0% 8/80 • Number of events 9 • 12 weeks
Immune system disorders Immune system disorders	6.2% 5/80 • Number of events 5 • 12 weeks
Nervous system disorders Nervous system disorders	3.8% 3/80 • Number of events 4 • 12 weeks
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	3.8% 3/80 • Number of events 3 • 12 weeks
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	2.5% 2/80 • Number of events 2 • 12 weeks
Hepatobiliary disorders Hepatobiliary disorders	2.5% 2/80 • Number of events 2 • 12 weeks
Ear and labyrinth disorders Ear and labyrinth disorders	1.2% 1/80 • Number of events 1 • 12 weeks
Social circumstances Social circumstances	1.2% 1/80 • Number of events 1 • 12 weeks
Cardiac disorders Cardiac disorders	1.2% 1/80 • Number of events 2 • 12 weeks
Reproductive system and breast disorders Reproductive system and breast disorders	1.2% 1/80 • Number of events 1 • 12 weeks
Psychiatric disorders Psychiatric disorders	1.2% 1/80 • Number of events 1 • 12 weeks
Surgical and medical procedures Surgical and medical procedures	1.2% 1/80 • Number of events 1 • 12 weeks

Additional Information

Sandra Rodrigues

Eurofarma Laboratórios S.A

Phone: 1150908600

Email: sandra.rodrigues@eurofarma.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60