Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505167
Status:
COMPLETED
Last Update Posted:
2008-12-29
First Post:
2007-07-20
Brief Title:
Memantine Versus Donepezil in Early Stages of Alzheimers Disease
Sponsor:
Hospital Miguel Servet
Organization:
Hospital Miguel Servet
Study Overview
Official Title:
Memantine Versus Donepezil in Mild to Moderate Alzheimers Disease A Randomized Trial With Magnetic Resonance Spectroscopy
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is well known that in the brain of the patients with Alzheimers 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 Alzheimers 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 activitiesWe 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 densityThen 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None