A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks

Inactive compound Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks

A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks
A mix of bioactive natural compounds: A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets

Food Supplement

Inactive compound Dosage form: tablets Dosage: 1 tablet per day Duration: 8 weeks
Placebo: Inactive compound in oral tablets

Placebo

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

TMT, which explores visual-conceptual and visual-motor tracking, is a frequently used neuropsychological test because of its sensitivity to brain damage. TMT is administered in two parts: TMT-A and TMT-B.
Part A is a visual-scanning, timed task where participants are asked to connect with lines 25 circles numbered from 1 to 25 as quickly as possible. The test is terminated after 5 minutes even if not completed.

Trial Making Test (TMT) A

TMT, which explores visual-conceptual and visual-motor tracking, is a frequently used neuropsychological test because of its sensitivity to brain damage. TMT is administered in two parts: TMT-A and TMT-B.
In Part B participants are asked to connect circles containing numbers (from 1 to 13) or letters (from A to L) in an alternate numeric/alphabetical order. The test is terminated in every case after 10 minutes even if not completed.

Trial Making Test (TMT) B

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.

Change in Trail Making Test (TMT) B 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.

Change 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.

Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment

Overall Study

Director of Clinical Operations

Cognitive Dysfunction

A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets

A mix of bioactive natural compounds

U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano

Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12

A. Menarini Industrie Farmaceutiche Riunite S.r.l.

9-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study

The study treatment was assigned through envelopes randomization system: the site was provided with sealed envelopes, numbered in progressive number starting from R-001, containing the treatment kit to be assigned to the subject. The Investigator will open the first available envelope in progressive order. Inside the envelope there will be the kit number of the treatment to be assigned to that subject.

bacopa monnieri/antioxidant

Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12

La base de dades d’herbes medicinals més completa avalada per la ciència