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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | All participants start the treatment with memantine on the first day of the study and immediately start vitamin D supplementation. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive performance | Cognitive performance is measured with Alzheimer's Disease Assessment Scale-cognition score (ADAS-cog) | This outcome is assessed at baseline, 12 and 24 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other cognitive scores | MMSE, Cognitive Assessment Battery, Frontal Assessment Battery, Trail Making Test parts A and B | This outcome is assessed at baseline, 12 and 24 weeks after inclusion |
| Change in functional performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cédric Annweiler, MD, PhD | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Angers | 49933 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22233455 | Derived | 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. | |
| 22014101 | Derived | 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. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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|
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| 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. |
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| 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. |
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Activities of Daily Living scale and 4-item Instrumental Activities of Daily Living scale
| This outcome is assessed at baseline, 12 and 24 weeks after inclusion |
| Change in posture and gait | Timed Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking | This outcome is assessed at baseline, 12 and 24 weeks after inclusion |
| Between-group comparison of compliance to treatment and tolerance | These outcomes are assessed together with the serum concentrations of 25OHD, calcium and parathyroid hormone. | This outcome is assessed at baseline, 12 and 24 weeks after inclusion |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |