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| Name | Class |
|---|---|
| BioFortis | OTHER |
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The hypothesis of this study is to evaluate the effect of supplementation for 8 weeks on the improvement of cognitive functions in healthy seniors with or without mild cognitive decline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Active Comparator | 2 capsules per day during 8 weeks |
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| Placebo | Placebo Comparator | 2 capsules per day during 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum | Dietary Supplement | After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3). |
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| Measure | Description | Time Frame |
|---|---|---|
| The change in mental fatigue | Mental fatigue is assessed twice on a VAS (Visual Analogue Scale) in the COMPASS test, which is a computerized test assessing cognitive functions. The first VAS is assessed following the cognitive Demand Battery comprising 3 tasks, namely a 3s serial subtraction task, a 7s serial subtraction task and another COMPASS task called Digit vigilance. | up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of global cognitive functioning | Assessed with MMSE score | up to 10 weeks |
| Evolution of cognitive function | Assessed with COMPASS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Unit Biofortis - Paris | Paris | 75012 | France | |||
| Clinical Investigation Unit of Biofortis - SHE |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
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This study is designed as a multicentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.
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| Placebo | Dietary Supplement | After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3). |
|
| up to 10 weeks |
| The frequency of adverse events | The frequency of subjects with at least one AE (Adverse Event), SAE (Serious Adverse Event), treatment-emergent AE and treatment-emergent SAE and the number of corresponding events | up to 10 weeks |
| Saint-Herblain |
| 44800 |
| France |