Memantine Versus Donepezil in Early Stages of Alzheimer's Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 20, 2007

Last Updated Date

December 26, 2008

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00505167 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Changes in the clinical scales observed after treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

Official Title ^†

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

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 Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Dementia, Alzheimer Type

Intervention ^†

Drug: Memantine
Drug: Donepezil

Study Arms / Comparison Groups

Active Comparator: Patients randomized to receive memantine
Active Comparator: Patients randomized to receive donepezil

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00505167

Responsible Party

Dr Pedro J Modrego, Department of Neurology. hospital Miguel Servet. Zaragoza. Spain

Secondary IDs ^††

Study Sponsor ^†

Hospital Miguel Servet

Collaborators ^††

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

Investigators ^†

Principal Investigator:

Pedro J Modrego, MD

Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain

Information Provided By

Hospital Miguel Servet

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.