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

Phase

2/3

Condition

Mild Cognitive Impairment

Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT01708005

2012-A00453-40

Ages > 60
All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

November 01, 2012

November 30, 2014

Study 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.

Connect with a study center

University Hospital
Angers, 49933
France
Site Not Available

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