Status:
COMPLETED
Alzheimer's Disease - Input of Vitamin D With mEmantine Assay
Lead Sponsor:
University Hospital, Angers
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 suf...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01409694
Start Date
September 1 2011
End Date
January 1 2016
Last Update
September 22 2016
Active Locations (1)
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1
University Hospital
Angers, France, 49933