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

NCT01409694 | Completed Phase 3 DMC

• 1 other identifier: 2010-024506-35
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Vitamin D; Cholecalciferol; Memantine; Cognition Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in other cognitive scores

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion

• Change in functional performance

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion

• Change in posture and gait

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion

• Between-group comparison of compliance to treatment and tolerance

  This outcome is assessed at baseline, 12 and 24 weeks after inclusion

Study Arms (2)

Intervention

ACTIVE COMPARATOR

All participants start the treatment with memantine on the first day of the study and immediately start vitamin D supplementation.

Drug: Memantine; Drug: Vitamin D

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.

Drug: Memantine; Drug: Vitamin D placebo

Interventions

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.

Also known as: Chlorhydrate de mémantine (Ebixa®)

Intervention; Placebo

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.

Also known as: Colecalciferol

Intervention

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.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The use of standard antidementia drugs (i.e., anticholinesterasics, memantine, or vasodilatators) in the past 60 days
• Severe hepatic or renal failure
• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital

Angers, 49933, France

Location

Related Publications (2)

• 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.

  PMID: 22233455 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.

  PMID: 22014101 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognition Disorders

Interventions

Memantine; Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Cédric Annweiler, MD, PhD

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2011-03

Locations

FR (1)