Alzheimer's Disease - Input of Vitamin D With mEmantine Assay (AD-IDEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01409694
First received: August 2, 2011
Last updated: October 10, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: Memantine
Drug: Vitamin D
Drug: Vitamin D placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Change in cognitive performance [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]
    Cognitive performance is measured with Alzheimer's Disease Assessment Scale-cognition score (ADAS-cog)


Secondary Outcome Measures:
  • Change in other cognitive scores [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]
    MMSE, Cognitive Assessment Battery, Frontal Assessment Battery, Trail Making Test parts A and B

  • Change in functional performance [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]
    Activities of Daily Living scale and 4-item Instrumental Activities of Daily Living scale

  • Change in posture and gait [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]
    Timed Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking

  • Between-group comparison of compliance to treatment and tolerance [ Time Frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion ] [ Designated as safety issue: Yes ]
    These outcomes are assessed together with the serum concentrations of 25OHD, calcium and parathyroid hormone.


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
All participants start the treatment with memantine on the first day of the study and immediately start vitamin D supplementation.
Drug: Memantine
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 Name: Chlorhydrate de mémantine (Ebixa®)
Drug: Vitamin D
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 Name: Colecalciferol
Placebo Comparator: 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.
Drug: Memantine
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 Name: Chlorhydrate de mémantine (Ebixa®)
Drug: Vitamin D placebo
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 Name: Placebo

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409694

Contacts
Contact: Cédric Annweiler, MD, PhD ++33 2 41 35 54 86 ceannweiler@chu-angers.fr

Locations
France
University Hospital Recruiting
Angers, France, 49933
Contact: Cédric Annweiler, MD, PhD    ++33 2 41 35 54 86    ceannweiler@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Cédric Annweiler, MD, PhD Angers University Hospital
  More Information

No publications provided by University Hospital, Angers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cedric Annweiler, MD, PhD, Angers University Hospital
ClinicalTrials.gov Identifier: NCT01409694     History of Changes
Other Study ID Numbers: 2010-024506-35
Study First Received: August 2, 2011
Last Updated: October 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés
France: Institutional Ethical Committee

Keywords provided by University Hospital, Angers:
Alzheimer Disease
Vitamin D
Cholecalciferol
Memantine
Cognition Disorders

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Memantine
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014