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| Sponsors and Collaborators: |
Hospital Miguel Servet Clinica Quiron de Zaragoza Universidad de Zaragoza Hospital de Barbastro Hospital Royo Villanova |
|---|---|
| Information provided by: | Hospital Miguel Servet |
| ClinicalTrials.gov Identifier: | NCT00505167 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dementia, Alzheimer Type |
Drug: Memantine Drug: Donepezil |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy. |
| Enrollment: | 64 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Patients randomized to receive memantine
|
Drug: Memantine
Patients randomized to receive either memantine or donepezil
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2: Active Comparator
Patients randomized to receive donepezil
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Drug: Donepezil
Patients randomized to receive either memantine or donepezil
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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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Cenro de especialidades San José. Hospital Miguel Servet | |
| Zaragoza, Spain, 50008 | |
| Hospital Royo Villanova | |
| Zaragoza, Spain | |
| Spain, Huesca | |
| Hospital de Barbastro | |
| Barbastro, Huesca, Spain, 50508 | |
| Principal Investigator: | Pedro J Modrego, MD | Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain |
More Information
| Responsible Party: | Department of Neurology. hospital Miguel Servet. Zaragoza. Spain ( Dr Pedro J Modrego ) |
| Study ID Numbers: | 0910-0459 |
| Study First Received: | July 20, 2007 |
| Last Updated: | December 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00505167 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
|
Alzheimer's disease Memantine Donepezil Magnetic resonance Spectroscopy randomized trial |
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Excitatory Amino Acids Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders |
Dopamine Mental Disorders Donepezil Memantine Dementia Delirium |
|
Nootropic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents Enzyme Inhibitors Excitatory Amino Acid Agents |
Cholinergic Agents Pharmacologic Actions Cholinesterase Inhibitors Therapeutic Uses Dopamine Agents Tauopathies Central Nervous System Agents Excitatory Amino Acid Antagonists |
