Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

Study Overview
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Brief Summary
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It is well known that in the brain of the patients with Alzheimer's disease there is a glutamatergic hyperstimulation leading to neuronal death. Memantine is a low affinity antagonist of NMDA glutamate receptors. The use of this drug in the early phases of the disease could provide neuroprotective effects and delay of progression. The effects of memantine should be compared to those of donepezil, which is the most prescribed anticholinesterase drug.

Detailed Description
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On the basis of the excess of glutamatergic stimulation, our objective is to demonstrate whether memantine could have a neuroprotective effect in Alzheimer's disease when administered in the early stages and in comparison to donepezil. The patients would be randomized to receive one of these drugs. At baseline we would evaluate the patients from a clinical standpoint with the ADAS-cog, the neuropsychiatric Inventory and a scale of daily living activities.We also would carry out Magnetic Resonance Spectroscopy in several areas of the brain (medial temporal lobe, prefrontal region, cingulate gyrus and occipital lobe) so as to measure the concentration of N-acetyl-aspartate which is a marker of neuronal density.Then we treat the patients with either memantine or denepezil and after 6 months we would repeat the same procedures as we did at baseline.

Official Title
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Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.

Conditions
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Dementia, Alzheimer Type

Intervention / Treatment
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* Drug: Memantine
* Drug: Donepezil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical criteria of probable Alzheimer's disease in the stages mild-to-moderate with a Mini-Mental score higher than 15 points. Exclusion Criteria: Previous treatment with anticholinesterase drugs or memantine. Advanced stages of the disease Lack of a reliable caregiver. Dementias other than Alzheimer's disease
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients randomized to receive memantine | Drug: Memantine<br>* Patients randomized to receive either memantine or donepezil<br>* Other names: Ebixa (Memantine);|
| Active Comparator: 2<br>Patients randomized to receive donepezil | Drug: Donepezil<br>* Patients randomized to receive either memantine or donepezil<br>* Other names: Aricept (Donepezil);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the clinical scales observed after treatment |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Memantine, Donepezil, Magnetic resonance Spectroscopy, randomized trial