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Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

Primary Purpose

Dementia, Alzheimer Type

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Memantine
Donepezil
Sponsored by
Hospital Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia, Alzheimer Type focused on measuring Alzheimer's disease, Memantine, Donepezil, Magnetic resonance Spectroscopy, randomized trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Barbastro
  • Cenro de especialidades San José. Hospital Miguel Servet
  • Hospital Royo Villanova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Patients randomized to receive memantine

Patients randomized to receive donepezil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in the clinical scales observed after treatment

Full Information

First Posted
July 20, 2007
Last Updated
December 26, 2008
Sponsor
Hospital Miguel Servet
Collaborators
Clinica Quiron de Zaragoza, Universidad de Zaragoza, Hospital de Barbastro, Hospital Royo Villanova
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1. Study Identification

Unique Protocol Identification Number
NCT00505167
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Miguel Servet
Collaborators
Clinica Quiron de Zaragoza, Universidad de Zaragoza, Hospital de Barbastro, Hospital Royo Villanova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Type
Keywords
Alzheimer's disease, Memantine, Donepezil, Magnetic resonance Spectroscopy, randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients randomized to receive memantine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients randomized to receive donepezil
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Ebixa (Memantine)
Intervention Description
Patients randomized to receive either memantine or donepezil
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aricept (Donepezil)
Intervention Description
Patients randomized to receive either memantine or donepezil
Primary Outcome Measure Information:
Title
Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in the clinical scales observed after treatment
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro J Modrego, MD
Organizational Affiliation
Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Barbastro
City
Barbastro
State/Province
Huesca
ZIP/Postal Code
50508
Country
Spain
Facility Name
Cenro de especialidades San José. Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50008
Country
Spain
Facility Name
Hospital Royo Villanova
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19874395
Citation
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.
Results Reference
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Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

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