Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

Phase 4

Completed

• Conditions: Dementia, Alzheimer Type
• Interventions: Drug: Donepezil; Drug: Memantine

• Registration Number: NCT00505167
• Lead Sponsor: Hospital Miguel Servet

Brief 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.

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Primary Completion: 2008-07
• Status Verified: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-26
• Last Update Posted: 2008-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Donepezil	Patients randomized to receive donepezil
1	Memantine	Patients randomized to receive memantine

Primary Outcome Measures

Name	Time	Method
Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.	6 months

Secondary Outcome Measures

Name	Time	Method
Changes in the clinical scales observed after treatment	6 months

Trial Locations

Locations (3)

Hospital de Barbastro; 🇪🇸 Barbastro, Huesca, Spain

Hospital Royo Villanova; 🇪🇸 Zaragoza, Spain

Cenro de especialidades San José. Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain