Alzheimer's DiseasePhase 3NCT00804271
Memantine and Validation of a New Alzheimer's Disease Scale
A Phase 3 study testing memantine in people with Alzheimer's Disease, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 487 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Nov 2009
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
- Signed informed consent prior to the initiation of any study specific procedures.
- Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.
Who cannot join
- Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
- Intake of any medication that is contra-indicated in combination with memantine.
- History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
- Known or suspected history of alcoholism or drug abuse within the past 2 years.
- Current or previous treatment with memantine or participation in an investigational study with memantine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.
- Conditions
- Alzheimer's Disease
- Being tested
- memantine
- 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 Axura
memantine tablets, OD, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Other | Not described Receives: Drug: memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
Measured: at post baseline visit
Secondary outcomes (1)
Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.
Measured: at a post baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vjera Holthoff, MD, Principal investigator, University Clinic Gustav Carus Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804271
- Sponsor's protocol ID
- MRZ 90001/AD/3001
- Other IDs
- EudraCT No. 2008-005144-16
- Status last verified
- Feb 2013
- First submitted
- 5 Dec 2008
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Holthoff V, Ferris S, Gauthier S, Ihl R, Robert P, Winblad B, Sternberg K, Tennigkeit F; ROSA Study Group. Memantine effects measured with the Relevant Outcome Scale for Alzheimer's disease in an open-label, single-arm, multicenter clinical study. Int J Geriatr Psychiatry. 2013 Feb;28(2):164-72. doi: 10.1002/gps.3805. Epub 2012 Apr 11.
PubMed 22492589Holthoff VA, Ferris S, Ihl R, Robert P, Winblad B, Gauthier S, Sternberg K, Tennigkeit F. Validation of the relevant outcome scale for Alzheimer's disease: a novel multidomain assessment for daily medical practice. Alzheimers Res Ther. 2011 Jul 6;3(5):27. doi: 10.1186/alzrt89.
PubMed 21914212
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine
- ClinicalTrials.gov ID
- NCT00804271
- Acronym / sponsor ID
- MRZ 90001/AD/3001
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Dec 2008 (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.
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memantine | Other | Drug: memantine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
- Signed informed consent prior to the initiation of any study specific procedures.
- Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.
Key exclusion criteria (5 listed)
- Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
- Intake of any medication that is contra-indicated in combination with memantine.
- History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
- Known or suspected history of alcoholism or drug abuse within the past 2 years.
- Current or previous treatment with memantine or participation in an investigational study with memantine.
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: Axuramemantine tablets, OD, 12 weeks | Drug | Memantine |
Primary outcome
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
Time frame: at post baseline visit
1 secondary outcome
Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.
Time frame: at a post baseline visit
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 22 Feb 2013.
- Results publication: PubMed 22492589Holthoff V, Ferris S, Gauthier S, Ihl R, Robert P, Winblad B, Sternberg K, Tennigkeit F; ROSA Study Group. Memantine effects measured with the Relevant Outcome Scale for Alzheimer's disease in an open-label, single-arm, multicenter clinical study. Int J Geriatr Psychiatry. 2013 Feb;28(2):164-72. doi: 10.1002/gps.3805. Epub 2012 Apr 11.
- Results publication: PubMed 21914212Holthoff VA, Ferris S, Ihl R, Robert P, Winblad B, Gauthier S, Sternberg K, Tennigkeit F. Validation of the relevant outcome scale for Alzheimer's disease: a novel multidomain assessment for daily medical practice. Alzheimers Res Ther. 2011 Jul 6;3(5):27. doi: 10.1186/alzrt89.
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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.
Vjera Holthoff, MD principal investigator
University Clinic Gustav Carus Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing memantine in people with Alzheimer's Disease, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
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 3 inclusion and 5 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 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms (time frame: at post baseline visit). 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 NCT00804271, which also lists 2 linked publications.
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 22 Feb 2013.