Alzheimer's Disease - Input of Vitamin D With mEmantine Assay

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect after 24 weeks of the oral intake of vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive performance in patients suffering from moderate Alzheimer's disease or related disorders (ADRD) and receiving memantine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Treatments: Cholecalciferol; Ergocalciferols; Memantine; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Age ≥ 60 years

• Diagnosis of moderate Alzheimer's disease or related disorders (DSM-IV/NINCDSADRDA) with a score of Mini-Mental State Examination (MMSE) between 10 and 20 inclusively

• To have hypovitaminosis D (i.e., serum 25-hydroxyvitamin D [25OHD]concentration < 30 ng/mL)

• To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65 mmol/L)

• To have given and signed an informed consent form to participate in the trial (or informed consent form obtained from the trusted person or legal representative, as appropriate)

• To be affiliated to French Social Security

Exclusion Criteria:

• The use of standard antidementia drugs (i.e., anticholinesterasics, memantine, or vasodilatators) in the past 60 days

• Severe hepatic or renal failure

• Severe, unstable or poorly controlled medical conditions at the time of the inclusion

• Other cognitive disorders (untreated dysthyroid, deficiency in vitamin B9 or B12, chronic ongoing ethylism, history of syphilis, stroke, delirium revealed with the Confusion Assessment Method (CAM), severe depressive symptomatology (Geriatric Depression score ≥ 10/15))

• Contra-indications to memantine or vitamin D

• Enrollment in another simultaneous clinical trial