DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)
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.
Inclusion Criteria:

 -  Age ≥ 60 years

 -  Memory complaints

 -  No dementia (DSM-IV, NINCDS-ADRDA negative)

 -  No depression (Geriatric Depression score ≤ 5/15)

 -  Ability to walk a distance of 15 meters unaided

 -  Diagnosis of MCI

 -  To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D [25OHD]concentration ≤
 30ng/mL)

 -  To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L)

 -  To have given and signed an informed consent to participate in the trial

 -  To be affiliated to French Social Security

 Exclusion Criteria:

 -  Others cognitive disorders (untreated thyroid dysfunction, chronic ongoing ethylism,
 history of syphilis, stroke, severe depressive symptomatology (Geriatric Depression
 score > 5/15), existence of dementia according to DSM-IV and NINCDS-ADRDA criteria at
 the time of inclusion)

 -  Vitamin D supplementation during inclusion

 -  Contraindications to vitamin D

 -  Unstable medical condition

 -  Enrollment in another simultaneous clinical trial

 -  Civil defense measures underway