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Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

NCT ID: NCT00505167

Last Updated: 2008-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia, Alzheimer Type

Keywords

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Alzheimer's disease Memantine Donepezil Magnetic resonance Spectroscopy randomized trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Patients randomized to receive memantine

Group Type ACTIVE_COMPARATOR

Memantine

Intervention Type DRUG

Patients randomized to receive either memantine or donepezil

2

Patients randomized to receive donepezil

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

Patients randomized to receive either memantine or donepezil

Interventions

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Memantine

Patients randomized to receive either memantine or donepezil

Intervention Type DRUG

Donepezil

Patients randomized to receive either memantine or donepezil

Intervention Type DRUG

Other Intervention Names

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Ebixa (Memantine) Aricept (Donepezil)

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Quiron de Zaragoza

UNKNOWN

Sponsor Role collaborator

Universidad de Zaragoza

OTHER

Sponsor Role collaborator

Hospital de Barbastro

UNKNOWN

Sponsor Role collaborator

Hospital Royo Villanova

UNKNOWN

Sponsor Role collaborator

Hospital Miguel Servet

OTHER

Sponsor Role lead

Responsible Party

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Department of Neurology. hospital Miguel Servet. Zaragoza. Spain

Principal Investigators

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Pedro J Modrego, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain

Locations

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Hospital de Barbastro

Barbastro, Huesca, Spain

Site Status

Cenro de especialidades San José. Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Hospital Royo Villanova

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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Modrego PJ, Fayed N, Errea JM, Rios C, Pina MA, Sarasa M. Memantine versus donepezil in mild to moderate Alzheimer's disease: a randomized trial with magnetic resonance spectroscopy. Eur J Neurol. 2010 Mar;17(3):405-12. doi: 10.1111/j.1468-1331.2009.02816.x. Epub 2009 Oct 28.

Reference Type DERIVED
PMID: 19874395 (View on PubMed)

Other Identifiers

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0910-0459

Identifier Type: -

Identifier Source: org_study_id