Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborators:
Clinica Quiron de Zaragoza
Universidad de Zaragoza
Hospital de Barbastro
Hospital Royo Villanova
Information provided by:
Hospital Miguel Servet
ClinicalTrials.gov Identifier:
NCT00505167
First received: July 20, 2007
Last updated: December 26, 2008
Last verified: December 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.

Resource links provided by NLM:


Further study details as provided by Hospital Miguel Servet:

Primary Outcome Measures:
  • Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the clinical scales observed after treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505167

Locations
Spain
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
Investigators
Principal Investigator: Pedro J Modrego, MD Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain
  More Information

No publications provided by Hospital Miguel Servet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Pedro J Modrego, Department of Neurology. hospital Miguel Servet. Zaragoza. Spain
ClinicalTrials.gov Identifier: NCT00505167     History of Changes
Other Study ID Numbers: 0910-0459
Study First Received: July 20, 2007
Last Updated: December 26, 2008
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Miguel Servet:
Alzheimer's disease
Memantine
Donepezil
Magnetic resonance Spectroscopy
randomized trial

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Donepezil
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Dopamine Agents
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014