The purpose of this study is to compare the effect after 12 weeks of the oral intake of Lecitone®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 Lecitone®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 Lecitone®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: * To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in executive performance in patients with a MCI. * To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in variability of stride time in patients with a MCI. * To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in executive performance in patients with a MCI. * To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with the effect of a placebo and a delay phase of supplementation on changes in variability of stride time in patients with a MCI. * To determine the compliance and tolerance of the oral intake of Lecitone®Se-Vitamin D3 in patients with a MCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
Lecitone®Se-Vitamin D3 is a dietary supplement combining the active ingredients in Lecitone®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form. Participants take 2 capsules of Lecitone®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.
The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.
University Hospital
Angers, France
Change in executive performance
Executive performance is measured with Trial Making Test part B (TMT B)
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
Change in other executive scores
Test parts A and B, Stoop test, Processing Speed Index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
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