An interventional study of A mix of bioactive natural compounds and Placebo in Cognitive Dysfunction, sponsored by A. Menarini Industrie Farmaceutiche Riunite S.r.l.. Completed at 1 site in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by A. Menarini Industrie Farmaceutiche Riunite S.r.l. · Not applicable, Interventional, and Prevention
Nine-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study.
The aim of this study is to evaluate the influence of a mix of four bioactive compounds - bacopa, lycopene, astaxanthin and vitamin B12 - on cognitive performance, mood state and well-being in subjects aged ≥ 60 years with no evidence of cognitive dysfunction.
The primary objective of the study is to evaluate the changes in Trial Making Test (TMT) scores from baseline (V2) to 8 weeks of treatment (V4), analyzed in the following hierarchical order: TMT-B, TMT-A and TMT B-A.
Secondary objectives of this study are to evaluate changes from baseline (V2) to 8 weeks of treatment (V4) in Verbal Fluency Test (VFT) score, Montreal Cognitive Assessment (MoCA) score, Mini Mental State Examination (MMSE) score, Rey Auditory Verbal Learning Test (AVLT), psychological well-being as assessed by General Health Questionnaire (GHQ-12), mood states as assessed by the Profile of Mood Stated (POMS), sexual satisfaction as evaluated by the New Sexual Satisfaction Scale (NSSS).
Changes of metabolic parameters from baseline (V2) to 4 weeks of treatment (V3) and from baseline (V2) to 8 weeks of treatment (V4) will be also evaluated as secondary objectives (glucose, insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, uric acid).
Changes of plasma markers of oxidative stress from baseline (V2) to 4 weeks of treatment (V3) and from baseline (V2) to 8 weeks of treatment (V4) will be evaluated as secondary objectives (8-iso-Prostaglandin F2alpha, Plasma malondialdehyde).
Finally the safety and tolerability of the study product will be assessed.
The study has been conducted in 1 Italian clinical site and involved 80 subjects.
Subjects will be randomly allocated to one of the following groups:
The study is double blind. Neither the study staff at clinical sites (Investigators, nurses, pharmacist) nor the subject was aware of the treatment assigned.
Each participant attended 4 visits over a total period of about 9 weeks.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 80 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →A. Menarini Industrie Farmaceutiche Riunite S.r.l. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks
Dietary Supplement: A mix of bioactive natural compounds
Inactive compound Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks
Dietary Supplement: Placebo
A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets
Inactive compound in oral tablets
Change in Trail Making Test (TMT) B Between Baseline and End of Treatment
Change in Trail Making Test (TMT) B scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Time frame: 8 weeks - from baseline to end of study
Change Trail Making Test (TMT) A Between Baseline and End of Treatment
Change in Trail Making Test (TMT) A scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Time frame: 8 weeks - from baseline to end of study
Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment
Change in Trail Making Test (TMT) B score minus Trail Making Test (TMT) A score from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Time frame: 8 weeks - from baseline to end of study
The recruitment period started on January 2018 and terminated on October 2018. A total of 80 subjetcs have been randomization and 78 completed the study. Each subject has been involved in the study for approximately two months. A total of 4 study visits has been performed for each subject.
| Milestone | Food Supplement | Placebo |
|---|---|---|
| Started | 40 | 40 |
| Completed | 38 | 40 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Change in Trail Making Test (TMT) B scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
| seconds | Food Supplement | Placebo |
|---|---|---|
| Change in Trail Making Test (TMT) B Between Baseline and End of Treatment | -17.63 ± 18.93 | 3.46 ± 13.08 |
Change in Trail Making Test (TMT) A scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
| seconds | Food Supplement | Placebo |
|---|---|---|
| Change Trail Making Test (TMT) A Between Baseline and End of Treatment | -6.86 ± 10.00 | -0.37 ± 5.31 |
Change in Trail Making Test (TMT) B score minus Trail Making Test (TMT) A score from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
| seconds | Food Supplement | Placebo |
|---|---|---|
| Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment | -10.46 ± 16.62 | 3.84 ± 11.65 |
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Food Supplement | 0/40 (0%) | 1/40 (2.5%) | 1/40 (2.5%) |
| Placebo | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Event | Food Supplement | Placebo |
|---|---|---|
| Hepatitis EInfections and infestations | 1/40 | 0/40 |
| Event | Food Supplement | Placebo |
|---|---|---|
| SinusitisRespiratory, thoracic and mediastinal disorders | 1/40 | 0/40 |
| Age, Categorical(Participants) | Food Supplement | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 39 | 76 |
| >=65 years | 3 | 1 | 4 |
| Age, Continuous(years) | Food Supplement | Placebo | Total |
|---|---|---|---|
| Mean | 61.88 ± 1.36 | 62.05 ± 1.55 | 61.96 ± 1.45 |
| Sex: Female, Male(Participants) | Food Supplement | Placebo | Total |
|---|---|---|---|
| Female | 28 | 27 | 55 |
| Male | 12 | 13 | 25 |
| Race (NIH/OMB)(Participants) | Food Supplement | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 40 | 40 | 80 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Food Supplement | Placebo | Total |
|---|---|---|---|
| Italy | 40 | 40 | 80 |
| Trial Making Test (TMT) A(seconds) | Food Supplement | Placebo | Total |
|---|---|---|---|
| Mean | 25.17 ± 10.53 | 24.20 ± 7.37 | 24.68 ± 8.95 |
| Trial Making Test (TMT) B(seconds) | Food Supplement | Placebo | Total |
|---|---|---|---|
| Mean | 56.97 ± 25.37 | 54.64 ± 21.30 | 55.80 ± 23.33 |
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A. Menarini Industrie Farmaceutiche Riunite S.r.l.