Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-31 @ 7:06 PM
Study NCT ID:
NCT01708005
Status:
UNKNOWN
Last Update Posted:
2012-10-16
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2012-10
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIET-D
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: