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Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00505167
Enrollment
64
Registered
2007-07-23
Start date
2007-07-31
Completion date
2008-12-31
Last updated
2008-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Alzheimer Type

Keywords

Alzheimer's disease, Memantine, Donepezil, Magnetic resonance Spectroscopy, randomized trial

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.

Interventions

DRUGMemantine

Patients randomized to receive either memantine or donepezil

DRUGDonepezil

Patients randomized to receive either memantine or donepezil

Sponsors

Clinica Quiron de Zaragoza
CollaboratorUNKNOWN
Universidad de Zaragoza
CollaboratorOTHER
Hospital de Barbastro
CollaboratorUNKNOWN
Hospital Royo Villanova
CollaboratorUNKNOWN
Hospital Miguel Servet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.6 months

Secondary

MeasureTime frame
Changes in the clinical scales observed after treatment6 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026