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

Alzheimer Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409694
• Other study ID #: 2010-024506-35
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2011
• Last updated: September 21, 2016
• Start date: September 2011
• Est. completion date: January 2016

Study information

• Verified date: March 2011
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertésFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in functional performance	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	No
Secondary	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	No
Secondary	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	Yes