Dementia, Alzheimer TypePhase 4NCT00505167
Memantine Versus Donepezil in Early Stages of Alzheimer's Disease
A Phase 4 study testing Memantine and Donepezil in people with Dementia, Alzheimer Type, run by Hospital Miguel Servet at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Alzheimer Type
- What is being tested?
- Memantine and Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesSpain
- Study dates
- Jul 2007to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical criteria of probable Alzheimer's disease in the stages mild-to-moderate with a Mini-Mental score higher than 15 points.
Who cannot join
- Previous treatment with anticholinesterase drugs or memantine.
- Advanced stages of the disease
- Lack of a reliable caregiver.
- Dementias other than Alzheimer's disease
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital de Barbastro
Barbastro, Huesca, 50508
Cenro de especialidades San José. Hospital Miguel Servet
Zaragoza, 50008
Hospital Royo Villanova
Zaragoza
About this study
Official title: Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.
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.
Read the 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.
- Conditions
- Dementia, Alzheimer Type
- Being tested
- Memantine, Donepezil
- Keywords
- Alzheimer's disease, Memantine, Donepezil, Magnetic resonance Spectroscopy, randomized trial
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Ebixa (Memantine)
Patients randomized to receive either memantine or donepezil
DonepezilDrug
Also called Aricept (Donepezil)
Patients randomized to receive either memantine or donepezil
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients randomized to receive memantine Receives: Drug: Memantine |
| 2 | Active comparator | Patients randomized to receive donepezil Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.
Measured: 6 months
Secondary outcomes (1)
Changes in the clinical scales observed after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia, Alzheimer TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Quiron de Zaragoza, Universidad de Zaragoza, Hospital de Barbastro, Hospital Universitario Royo Villanova
- Investigators
- Pedro J Modrego, MD, Principal investigator, Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505167
- Sponsor's protocol ID
- 0910-0459
- Status last verified
- Dec 2008
- First submitted
- 20 Jul 2007
- Last updated
- 29 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19874395
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.
- ClinicalTrials.gov ID
- NCT00505167
- Acronym / sponsor ID
- 0910-0459
- Conditions
- Dementia, Alzheimer Type
- Keywords
- Alzheimer's disease, Memantine, Donepezil, Magnetic resonance Spectroscopy, randomized trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Collaborators
- Clinica Quiron de Zaragoza, Universidad de Zaragoza, Hospital de Barbastro, Hospital Universitario Royo Villanova
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MemantinePatients randomized to receive memantine |
| 2 | Active comparator | Drug: DonepezilPatients randomized to receive donepezil |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical criteria of probable Alzheimer's disease in the stages mild-to-moderate with a Mini-Mental score higher than 15 points.
Key exclusion criteria (4 listed)
- Previous treatment with anticholinesterase drugs or memantine.
- Advanced stages of the disease
- Lack of a reliable caregiver.
- Dementias other than Alzheimer's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: Ebixa (Memantine)Patients randomized to receive either memantine or donepezil | Drug | 1 |
| DonepezilAlso: Aricept (Donepezil)Patients randomized to receive either memantine or donepezil | Drug | 2 |
Primary outcome
Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.
Time frame: 6 months
1 secondary outcome
Changes in the clinical scales observed after treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2008.
- Derived from this study: PubMed 19874395Modrego 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro J Modrego, MD principal investigator
Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine and Donepezil in people with Dementia, Alzheimer Type, run by Hospital Miguel Servet at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00505167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2008.