Memory DisorderPhase 2NCT01261741
Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems
A Phase 2 study testing Memantine in people with Memory Disorder and Retention Disorder, Cognitive, run by Merz Pharmaceuticals GmbH at 14 sites in 2 countries.
Trial summary
In this study, memantine will be tested in a new indication: in the treatment of subjective memory, concentration, or attention problems (subjective cognitive impairment) in the absence of dementia. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Memory Disorder, Retention Disorder, Cognitive, Subjective Cognitive Impairment
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective worsening of memory, concentration or attention problems for longer than 6 months
- Subject can confirm that a relative or friend has noticed the memory, concentration or attention problems of the subject
- Experience of the memory, concentration or attention problems at least four times per week
Who cannot join
- Significant neurological disease or major psychiatric disorder (e.g. diagnosis of psychosis or dementia)
- Significant systemic illness, such as cancer, heart or kidney failure, uncontrolled diabetes
- History of stroke or seizure, or myocardial infarction within the last year (e.g. by inclusion questionnaire, physician interview)
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Germany11 sites
Universitätsklinikum der RWTH Aachen
Aachen, 52074
Praxis Dr. Heidenreich
Böblingen, 71032
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Praxis Dr. Albrecht
Ellwangen, 73479
Praxis Dr. Reifschneider
Erbach im Odenwald, 64711
Klinische Forschung Hannover-Mitte
Hanover, 30159
ZSL Zentrum für medizinische Studien in Leipzig
Leipzig, 04157
Klinische Forschung Berlin-Mitte
Mitte, 10117
Praxis Dr. Pauls
München, 80331
Praxis Dr. Kühn
Oranienburg, 16515
Praxis Dr. Krause
Wolfratshausen, 82515
United Kingdom3 sites
Royal United Hospital
Bath, BA1 3NG
Community Pharmacology Services (CPS)
Glasgow, G20 0XA
Moorgreen Hospital
West End, Southampton, SO30 3JB
About this study
Official title: Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of 10mg Memantine in the Treatment of Memory, Concentration or Attention Problems in the Absence of Dementia
In this study, memantine will be tested in a new indication: in the treatment of subjective memory, concentration, or attention problems (subjective cognitive impairment) in the absence of dementia.
- Conditions
- Memory Disorder, Retention Disorder, Cognitive, Subjective Cognitive Impairment, Memory, Concentration or Attention Problems
- Being tested
- Memantine, Placebo
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Each subject will receive memantine 10mg tablets once daily
PlaceboDrug
Each subject will receive matching placebo tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | Not described Receives: Drug: Memantine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Patient Global Impression of Change" (PGI-C) at visit 4
It is the statistical comparison between the placebo group and the memantine group.The group comparison will be performed by the use of an analysis of covariance (ANCOVA) model.
Measured: 12 weeks
Secondary outcomes (4)
Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)
Measured: 16 weeks
Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score
Measured: 12 weeks
Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score
Measured: 12 weeks
Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionSep 2011
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 Memory DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261741
- Sponsor's protocol ID
- MRZ 90001-2267 / 1
- Other IDs
- 2010-020737-50
- Status last verified
- Nov 2013
- First submitted
- 15 Dec 2010
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schulz JB, Acker C, Seitzinger A, Pulte I. Randomized, double-blind, placebo-controlled, multicentre study to investigate memantine in the treatment of memory, concentration, and attention problems (subjective cognitive impairment). Journal of the Neurological Sciences 333 Suppl.1: e332, 2013. doi:10.1016/j.jns.2013.07.1232
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of 10mg Memantine in the Treatment of Memory, Concentration or Attention Problems in the Absence of Dementia
- ClinicalTrials.gov ID
- NCT01261741
- Acronym / sponsor ID
- MRZ 90001-2267 / 1
- Conditions
- Memory Disorder, Retention Disorder, Cognitive, Subjective Cognitive Impairment, Memory, Concentration or Attention Problems
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Dec 2010 (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.
In this study, memantine will be tested in a new indication: in the treatment of subjective memory, concentration, or attention problems (subjective cognitive impairment) in the absence of dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: Memantine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjective worsening of memory, concentration or attention problems for longer than 6 months
- Subject can confirm that a relative or friend has noticed the memory, concentration or attention problems of the subject
- Experience of the memory, concentration or attention problems at least four times per week
Key exclusion criteria (3 listed)
- Significant neurological disease or major psychiatric disorder (e.g. diagnosis of psychosis or dementia)
- Significant systemic illness, such as cancer, heart or kidney failure, uncontrolled diabetes
- History of stroke or seizure, or myocardial infarction within the last year (e.g. by inclusion questionnaire, physician interview)
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 |
|---|---|---|
| MemantineEach subject will receive memantine 10mg tablets once daily | Drug | Memantine |
| PlaceboEach subject will receive matching placebo tablets once daily | Drug | Placebo |
Primary outcome
"Patient Global Impression of Change" (PGI-C) at visit 4
Time frame: 12 weeks
It is the statistical comparison between the placebo group and the memantine group.The group comparison will be performed by the use of an analysis of covariance (ANCOVA) model.
4 secondary outcomes
Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)
Time frame: 16 weeks
Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score
Time frame: 12 weeks
Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score
Time frame: 12 weeks
Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.
Time frame: 16 weeks
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 27 Nov 2013.
- Results publicationSchulz JB, Acker C, Seitzinger A, Pulte I. Randomized, double-blind, placebo-controlled, multicentre study to investigate memantine in the treatment of memory, concentration, and attention problems (subjective cognitive impairment). Journal of the Neurological Sciences 333 Suppl.1: e332, 2013. doi:10.1016/j.jns.2013.07.1232
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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.
Merz Medical Expert study director
Merz Pharmaceuticals GmbH
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine in people with Memory Disorder and Retention Disorder, Cognitive, run by Merz Pharmaceuticals GmbH at 14 sites in 2 countries.
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 3 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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, United Kingdom. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
"Patient Global Impression of Change" (PGI-C) at visit 4 (time frame: 12 weeks). 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 NCT01261741, 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 27 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.