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

September 21, 2016 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
This outcome is assessed at baseline, 12 and 24 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
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
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
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
This outcome is assessed at baseline, 12 and 24 weeks after inclusion
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.
This outcome is assessed at baseline, 12 and 24 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Cedric ANNWEILER, MD, PhD, Angers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-024506-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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