Alzheimer Disease Clinical Trial
Official title:
Evaluation d'Une stratégie thérapeutique d'Association médicamenteuse Pour la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées au Stade modéré
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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