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Completed

NCT Number: NCT01409694

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

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.

Other names: Chlorhydrate de mémantine (Ebixa®)

Vitamin D

Drug

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.

Other names: Colecalciferol

Vitamin D placebo

Drug

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.

Other names: Placebo

Primary outcomes

  1. Change in cognitive performance

    Time frame: 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 outcomes

  1. Change in other cognitive scores

    Time frame: 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

  2. Change in functional performance

    Time frame: 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

  3. Change in posture and gait

    Time frame: 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

  4. Between-group comparison of compliance to treatment and tolerance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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

Acronym: AD-IDEA

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2011
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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