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.
Current treatments for Alzheimer's disease and related disorders (ADRD) are symptomatic and can only temporarily slow down ADRD. Future possibilities of care could rely on multi-target drugs therapies that address simultaneously several pathophysiological processes leading to neurodegeneration. We hypothesized that the combination of memantine with vitamin D could be neuroprotective in ADRD, thereby limiting neuronal loss and cognitive decline. The primary objective of this trial is to compare the effect after 24 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of cognitive performance in patients suffering from moderate ADRD and receiving memantine. The secondary objectives of the study are as follows: * To compare the effect after 12 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of cognitive performance in patients suffering from moderate ADRD and receiving memantine. * To compare the effect after 12 and 24 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of functional abilities in patients suffering from moderate ADRD and receiving memantine. * To compare the effect after 12 and 24 weeks of the oral intake of vitamin D3 with the effect of a placebo on the evolution of postural and gait performance in patients suffering from moderate ADRD and receiving memantine. * To determine the compliance to treatment and tolerance of the oral intake of vitamin D3 in patients suffering from moderate ADRD and receiving memantine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Memantine is administered to all participants according to the usual strategy, with upward titration of 5 mg per week during the first three weeks to reduce the risk of side effects. The final dosage is 20 mg per day, with no subsequent modification of dosage or specialty during the trial.
Subjects receive Vitamin D supplementation (cholecalciferol 100,000 IU, drinking solution, 2 mL vial) at a rate of 1 drinking vial of 100,000 IU cholecalciferol every month. In brief, the total dose is 600,000 IU over the duration of the study starting with one vial at the time of inclusion, then at week(W) 4, W8, W12, W16 and W20. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study.
University Hospital
Angers, France
Change in cognitive performance
Cognitive performance is measured with Alzheimer's Disease Assessment Scale-cognition score (ADAS-cog)
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Change in other cognitive scores
MMSE, Cognitive Assessment Battery, Frontal Assessment Battery, Trail Making Test parts A and B
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Change in functional performance
Activities of Daily Living scale and 4-item Instrumental Activities of Daily Living scale
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Change in posture and gait
Timed Up \& Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Between-group comparison of compliance to treatment and tolerance
These outcomes are assessed together with the serum concentrations of 25OHD, calcium and parathyroid hormone.
Time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
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Subjects receive Vitamin D placebo (drinking solution, 2mL vial) at a rate of 1 drinking vial every month. In brief, the subjects start with one vial at the time of inclusion, then at week(W)4, W8, W12, W16 and W20. The placebo drinking solution contains all the excipients present in the Vitamin D vial.