Alzheimer's Disease - Input of Vitamin D With mEmantine Assay (AD-IDEA)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Memantine
Vitamin D
Vitamin D placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Vitamin D, Cholecalciferol, Memantine, Cognition Disorders
Eligibility 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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
All participants start the treatment with memantine on the first day of the study and immediately start vitamin D supplementation.
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.
Outcomes
Primary Outcome Measures
Change in cognitive performance
Cognitive performance is measured with Alzheimer's Disease Assessment Scale-cognition score (ADAS-cog)
Secondary Outcome Measures
Change in other cognitive scores
MMSE, Cognitive Assessment Battery, Frontal Assessment Battery, Trail Making Test parts A and B
Change in functional performance
Activities of Daily Living scale and 4-item Instrumental Activities of Daily Living scale
Change in posture and gait
Timed Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Between-group comparison of compliance to treatment and tolerance
These outcomes are assessed together with the serum concentrations of 25OHD, calcium and parathyroid hormone.
Full Information
NCT ID
NCT01409694
First Posted
August 2, 2011
Last Updated
September 21, 2016
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT01409694
Brief Title
Alzheimer's Disease - Input of Vitamin D With mEmantine Assay
Acronym
AD-IDEA
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer Disease, Vitamin D, Cholecalciferol, Memantine, Cognition Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
All participants start the treatment with memantine on the first day of the study and immediately start vitamin D supplementation.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Chlorhydrate de mémantine (Ebixa®)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Colecalciferol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D placebo
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cognitive performance
Description
Cognitive performance is measured with Alzheimer's Disease Assessment Scale-cognition score (ADAS-cog)
Time Frame
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Secondary Outcome Measure Information:
Title
Change in other cognitive scores
Description
MMSE, Cognitive Assessment Battery, Frontal Assessment Battery, Trail Making Test parts A and B
Time Frame
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Title
Change in functional performance
Description
Activities of Daily Living scale and 4-item Instrumental Activities of Daily Living scale
Time Frame
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Title
Change in posture and gait
Description
Timed Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
Time Frame
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
Title
Between-group comparison of compliance to treatment and tolerance
Description
These outcomes are assessed together with the serum concentrations of 25OHD, calcium and parathyroid hormone.
Time Frame
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric Annweiler, MD, PhD
Organizational Affiliation
Angers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22233455
Citation
Annweiler C, Beauchet O. Possibility of a new anti-alzheimer's disease pharmaceutical composition combining memantine and vitamin D. Drugs Aging. 2012 Feb 1;29(2):81-91. doi: 10.2165/11597550-000000000-00000.
Results Reference
derived
PubMed Identifier
22014101
Citation
Annweiler C, Fantino B, Parot-Schinkel E, Thiery S, Gautier J, Beauchet O. Alzheimer's disease--input of vitamin D with mEmantine assay (AD-IDEA trial): study protocol for a randomized controlled trial. Trials. 2011 Oct 20;12:230. doi: 10.1186/1745-6215-12-230.
Results Reference
derived
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Alzheimer's Disease - Input of Vitamin D With mEmantine Assay
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