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Trial record 82 of 331 for:    DONEPEZIL

Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505167
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : December 29, 2008
Clinica Quiron de Zaragoza
Universidad de Zaragoza
Hospital de Barbastro
Hospital Royo Villanova
Information provided by:
Hospital Miguel Servet

Brief Summary:
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 or disease Intervention/treatment Phase
Dementia, Alzheimer Type Drug: Memantine Drug: Donepezil Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.
Study Start Date : July 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Active Comparator: 1
Patients randomized to receive memantine
Drug: Memantine
Patients randomized to receive either memantine or donepezil
Other Name: Ebixa (Memantine)

Active Comparator: 2
Patients randomized to receive donepezil
Drug: Donepezil
Patients randomized to receive either memantine or donepezil
Other Name: Aricept (Donepezil)

Primary Outcome Measures :
  1. Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Changes in the clinical scales observed after treatment [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505167

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Hospital de Barbastro
Barbastro, Huesca, Spain, 50508
Cenro de especialidades San José. Hospital Miguel Servet
Zaragoza, Spain, 50008
Hospital Royo Villanova
Zaragoza, Spain
Sponsors and Collaborators
Hospital Miguel Servet
Clinica Quiron de Zaragoza
Universidad de Zaragoza
Hospital de Barbastro
Hospital Royo Villanova
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Principal Investigator: Pedro J Modrego, MD Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Pedro J Modrego, Department of Neurology. hospital Miguel Servet. Zaragoza. Spain Identifier: NCT00505167     History of Changes
Other Study ID Numbers: 0910-0459
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: December 29, 2008
Last Verified: December 2008
Keywords provided by Hospital Miguel Servet:
Alzheimer's disease
Magnetic resonance Spectroscopy
randomized trial
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents