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Alzheimer's Disease - Input of Vitamin D With mEmantine Assay | Clinical Trials | Clareo Health

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

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

NCT01409694•University Hospital, Angers

View on ClinicalTrials.gov

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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University Hospital

Angers, France

Key Dates

Start Date

September 1, 2011

Primary Completion Date

January 1, 2016

Completion Date

January 1, 2016

Last Updated

September 22, 2016

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

Memantine

DRUG

Vitamin D

DRUG

Vitamin D placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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