Clinical trial NCT00505167: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia, Alzheimer Type
Keywords: Alzheimer's disease
Memantine
Donepezil
Magnetic resonance Spectroscopy
randomized trial
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Clinica Quiron de Zaragoza
name: Universidad de Zaragoza
name: Hospital de Barbastro
name: Hospital Royo Villanova
First posted: 2007-07-23
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.
timeFrame: 6 months
Secondary outcomes:
measure: Changes in the clinical scales observed after treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Barbastro
country: Spain
facility: Hospital de Barbastro
state: Huesca
city: Zaragoza
country: Spain
facility: Cenro de especialidades San José. Hospital Miguel Servet
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
Study officials:
affiliation: Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain
name: Pedro J Modrego, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.