Status:
COMPLETED
Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12
Lead Sponsor:
A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Conditions:
Cognitive Dysfunction
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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, as...
Detailed Description
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: * Group I: mix of the four bioactive compounds (...
Eligibility Criteria
Inclusion
- Subjects aged ≥60 years.
- Subjects who provide written Informed Consent to the study.
Exclusion
- Subjects with cognitive dysfunctions or clinically significant coexisting medical conditions (cardiovascular disease, cerebrovascular events, overt dementia defined by MMSE \<27 or other neurological disorders, thyroid disorders, or inflammatory diseases)
- Subjects with a score on the Geriatric Depression Scale (GDS) \>11 in order to avoid confounding due to the influence of concomitant depression on the performance on cognitive tests
- Current smokers
- Habitual users of antioxidant supplements (including vitamins C and E)
- Habitual consumers of chocolate or other cocoa products (daily consumption of any amount)
- Subjects under treatments with medications known to have antioxidant properties (including statins and glitazones) or to interfere with cognitive functions (including benzodiazepines and antidepressants)
- Subjects with hypersensitivity to any component of the study medications
- Subjects who are participating in or having participated in another clinical trial within the previous three months.
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03825042
Start Date
January 23 2018
End Date
October 29 2018
Last Update
July 27 2020
Active Locations (1)
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1
U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano
Avezzano, L'Aquila, Italy, 67051