DIetary Supplements, Executive funcTions and Vitamin D (DIET-D) — DIET-D  

Mild Cognitive Impairment Clinical Trial

Official title: DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial

Status Enrolling by invitation

Clinical Trial Summary

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).

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

• NCT number: NCT01708005
• Study type: Interventional
• Source: University Hospital, Angers
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: November 2012
• Completion date: November 2014