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Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

Information source: Hospital Miguel Servet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dementia, Alzheimer Type

Intervention: Memantine (Drug); Donepezil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Miguel Servet

Official(s) and/or principal investigator(s):
Pedro J Modrego, MD, Principal Investigator, Affiliation: Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.

Secondary outcome: Changes in the clinical scales observed after treatment

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Cenro de especialidades San José. Hospital Miguel Servet, Zaragoza 50008, Spain

Hospital Royo Villanova, Zaragoza, Spain

Hospital de Barbastro, Barbastro, Huesca 50508, Spain

Additional Information

Starting date: July 2007
Last updated: December 26, 2008

Page last updated: August 23, 2015

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