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| Name | Class |
|---|---|
| Nantes University Hospital | OTHER |
| NUTRISANTE | UNKNOWN |
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The purpose of this study is to compare the effect after 12 weeks of the oral intake of LecitoneĀ®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive performance in Trial Making Test score part B (this test evaluate executive functions of mental flexibility) in older adults with Mild Cognitive Impairment (MCI).
Current treatments for Alzheimer's disease (AD) are symptomatic and can only temporarily slow down AD without altering its natural evolution. The development of new therapies has primarily focused on preventing the progression of AD. This therapeutic strategy involves being interested in patients with an early stage of AD such as a mild cognitive impairment (MCI). We hypothesized that the combination of LecitoneĀ®Se with 200 IU/day of vitamin D can slow or even improve cognitive decline, particularly executive functions.
The primary objective of this trial is to compare the effect after 12 weeks of the oral intake of LecitoneĀ®Se-Vitamin D3 with the effect of a placebo on changes in performance obtained in the TMT B in the older adults with a MCI.
The secondary objectives of the study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 80 participants start the oral intake of LecitoneĀ®Se-Vitamin D3 the day after inclusion and during 24 weeks |
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| Placebo | Placebo Comparator | 80 participants in this arm start the oral intake of placebo the day after inclusion and during 12 weeks. Then, they start the oral intake of LecitoneĀ®Se-Vitamin D3 12 weeks after inclusion until the 24th week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LecitoneĀ®Se-Vitamin D3 | Drug | LecitoneĀ®Se-Vitamin D3 is a dietary supplement combining the active ingredients in LecitoneĀ®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form. Participants take 2 capsules of LecitoneĀ®Se -Vitamin D3 per day. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in executive performance | Executive performance is measured with Trial Making Test part B (TMT B) | This outcome is assessed at baseline, 12 and 24 weeks after inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other executive scores | Test parts A and B, Stoop test, Processing Speed Index | This outcome is assessed at baseline, 12 and 24 weeks after inclusion. |
| Change in posture | Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Beauchet, MD,PhD | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Angers | 49933 | France |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that LecitoneĀ®Se-Vitamin D3 capsules. |
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| This outcome is assessed at baseline, 12 and 24 weeks after inclusion. |
| Between-group comparison of compliance to treatment | This outcome is assessed together with the serum concentrations of 25OHD and calcium | This outcome is assessed at baseline, 12 and 24 weeks after inclusion. |
| Change in gait | Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking | This outcome is assessed at baseline, 12 and 24 weeks after inclusion |
| Between-group comparison of tolerance | This outcome is assessed with the serum concentrations of 25OHD and calcium | This outcome is assessed at baseline, 12 and 24 weeks after inclusion |