Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

Dementia, Alzheimer Type Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505167
• Other study ID #: 0910-0459
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2007
• Last updated: December 26, 2008
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia, Alzheimer Type

Intervention

Drug:
• Memantine
Patients randomized to receive either memantine or donepezil
• Donepezil
Patients randomized to receive either memantine or donepezil

Locations

Country	Name	City	State
Spain	Hospital de Barbastro	Barbastro	Huesca
Spain	Cenro de especialidades San José. Hospital Miguel Servet	Zaragoza
Spain	Hospital Royo Villanova	Zaragoza

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Miguel Servet	Clinica Quiron de Zaragoza, Hospital de Barbastro, Hospital Royo Villanova, Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.		6 months	No
Secondary	Changes in the clinical scales observed after treatment		6 months	No