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NCT Number: NCT00505167

Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

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.

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Key information

Conditions

Dementia, Alzheimer Type Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Barbastro, Barbastro, Huesca, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

Patients randomized to receive either memantine or donepezil

Other names: Ebixa (Memantine)

Donepezil

Drug

Patients randomized to receive either memantine or donepezil

Other names: Aricept (Donepezil)

Primary outcomes

  1. Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.

    Time frame: 6 months

Secondary outcomes

  1. Changes in the clinical scales observed after treatment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Collaborators

  • Clinica Quiron de Zaragoza
  • Hospital Royo Villanova
  • Hospital de Barbastro
  • Universidad de Zaragoza

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 23, 2007
Registry last updated
Dec 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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