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

Phase 3

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Memantine; Drug: Vitamin D placebo; Drug: Vitamin D

• Registration Number: NCT01409694
• Lead Sponsor: University Hospital, Angers

Brief 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.

Detailed Description

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 Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Study Start: 2011-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Vitamin D placebo	Participants in this arm start the treatment with memantine in the same way as the 'Intervention' group. They also immediately start Vitamin D placebo administered at the same pace.
Placebo	Memantine	Participants in this arm start the treatment with memantine in the same way as the 'Intervention' group. They also immediately start Vitamin D placebo administered at the same pace.
Intervention	Vitamin D	All participants start the treatment with memantine on the first day of the study and immediately start vitamin D supplementation.
Intervention	Memantine	All participants start the treatment with memantine on the first day of the study and immediately start vitamin D supplementation.

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	Cognitive performance is measured with Alzheimer's Disease Assessment Scale-cognition score (ADAS-cog)

Secondary Outcome Measures

Name	Time	Method
Change in other cognitive scores	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	MMSE, Cognitive Assessment Battery, Frontal Assessment Battery, Trail Making Test parts A and B
Change in functional performance	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	Activities of Daily Living scale and 4-item Instrumental Activities of Daily Living scale
Change in posture and gait	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	Timed Up \& Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Between-group comparison of compliance to treatment and tolerance	This outcome is assessed at baseline, 12 and 24 weeks after inclusion	These outcomes are assessed together with the serum concentrations of 25OHD, calcium and parathyroid hormone.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France