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

University Hospital, Angers

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Mild Cognitive Impairment

Treatments: Drug: Lecitone®Se-Vitamin D3; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01708005

2012-A00453-40

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks

Treatment:

Drug: Lecitone®Se-Vitamin D3

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo