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

Phase 2

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Placebo; Drug: Lecitone®Se-Vitamin D3

• Registration Number: NCT01708005
• Lead Sponsor: University Hospital, Angers

Brief 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).

Detailed 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 Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-15
• Last Update Submitted: 2012-10-15
• Study First Posted: 2012-10-16
• Last Update Posted: 2012-10-16
• Study Start: 2012-11
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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 Lecitone®Se-Vitamin D3 12 weeks after inclusion until the 24th week.
Intervention	Lecitone®Se-Vitamin D3	80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks

Primary Outcome Measures

Name	Time	Method
Change in executive performance	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	Executive performance is measured with Trial Making Test part B (TMT B)

Secondary Outcome Measures

Name	Time	Method
Change in other executive scores	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	Test parts A and B, Stoop test, Processing Speed Index
Change in posture	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	Time Up \& Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Between-group comparison of compliance to treatment	This outcome is assessed at baseline, 12 and 24 weeks after inclusion.	This outcome is assessed together with the serum concentrations of 25OHD and calcium
Change in gait	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	Time Up \& Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Between-group comparison of tolerance	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	This outcome is assessed with the serum concentrations of 25OHD and calcium

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France