DEMENTIAPhase 4MAGDNCT00371059
Memantine for Agitation in Dementia
A Phase 4 study testing Memantine in people with DEMENTIA, run by East Kent Hospitals University NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- DEMENTIA
- What is being tested?
- Memantine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2007to Sep 2009
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
- Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4.
- Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19).
- Clinically significant agitation that requires treatment.
- Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45.
- Age >/= 55.
Who cannot join
- Memantine usage in the 4 weeks prior to the start of the study.
- On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
- Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
- Antiparkinsonian medication.
- Hypersensitivity to memantine or any of the excipients in the formulation.
- Severe renal impairment.
Show all 14Show fewer
- Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.
- Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
- Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
- Severe, unstable or poorly controlled medical illness.
- Any disability that may interfere with the patient completing the study procedure.
- Active malignancy.
- Delirium, pain or any medical illness as a clear cause of agitation.
- Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorphan, Dopaminergics- amantadine, Warfarin due to theoretical INR prolongation.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Oxleas Nhs Foundation Trust
Dartford, KENT, DA2 7WG
Kent and Medway NHS and Social Care Partnership Trust
Folkestone, Kent, ct20 1jy
About this study
Official title: Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks
Read the detailed description
Agitation is a cause of morbidity and mortality in Alzheimer's due to distress and use of medication with side effects. Memantine has beed shown to be associated with less agitation and a recent study by forrest pharmaceuticals failed to recruit. We will perform a 12 week rct in 164 patients to test this hypothesis in a locality with no competing studies and in a clinical setting where the drug is not often used. We will compare with placebo and also use a rescue protocol derived from international best practice.
- Conditions
- DEMENTIA
- Being tested
- Memantine, Placebo
- Keywords
- Agitation, Dementia, Alzheimer's
- Medical subject headings
- Dementia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Memantine 10mg BD
PlaceboDrug
Placebo 10 mgs BD
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen-Mansfield
Measured: 2 weeks
Secondary outcomes (7)
Neuropsychiatric Inventory 6+12 weeks
Measured: 2 weeks
Clinical Global Impression 6+ 12 weeks
Measured: 2 weeks
Severe Impairment Battery 6+12 weeks
Measured: 2 weeks
Quality of Life 6+12 weeks
Measured: 2 weeks
Co-meds
Measured: 2 weeks
Incidents of agitation
Measured: 2 weeks
Use of rescue protocol
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionSep 2009
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 DEMENTIAStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Kent Hospitals University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Oxford, Institute of Psychiatry, London, University of London, University College, London, Indiana University
- Responsible party
- Sponsor
- Investigators
- CHRIS FOX, MBBSBscMSC, Principal investigator, KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371059
- Sponsor's protocol ID
- 2005-005087-93
- Other IDs
- ISRCTN 24953404, 2005
- Acronym
- MAGD
- Status last verified
- Mar 2022
- First submitted
- 30 Aug 2006
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fox C, Crugel M, Maidment I, Auestad BH, Coulton S, Treloar A, Ballard C, Boustani M, Katona C, Livingston G. Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial. PLoS One. 2012;7(5):e35185. doi: 10.1371/journal.pone.0035185. Epub 2012 May 2.
PubMed 22567095
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
- ClinicalTrials.gov ID
- NCT00371059
- Acronym / sponsor ID
- MAGD / 2005-005087-93
- Conditions
- DEMENTIA
- Keywords
- Agitation, Dementia, Alzheimer's
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- East Kent Hospitals University NHS Foundation TrustOther government
- Collaborators
- University of Oxford, Institute of Psychiatry, London, University of London, University College, London, Indiana University
- Study start
- Sep 2007 (actual)
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Sep 2006 (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.
We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks
Detailed description
Agitation is a cause of morbidity and mortality in Alzheimer's due to distress and use of medication with side effects. Memantine has beed shown to be associated with less agitation and a recent study by forrest pharmaceuticals failed to recruit. We will perform a 12 week rct in 164 patients to test this hypothesis in a locality with no competing studies and in a clinical setting where the drug is not often used. We will compare with placebo and also use a rescue protocol derived from international best practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
- Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4.
- Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19).
- Clinically significant agitation that requires treatment.
- Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45.
Key exclusion criteria (14 listed)
- Memantine usage in the 4 weeks prior to the start of the study.
- On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
- Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
- Antiparkinsonian medication.
- Hypersensitivity to memantine or any of the excipients in the formulation.
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 |
|---|---|---|
| MemantineMemantine 10mg BD | Drug | – |
| PlaceboPlacebo 10 mgs BD | Drug | – |
Primary outcome
Cohen-Mansfield
Time frame: 2 weeks
7 secondary outcomes
Neuropsychiatric Inventory 6+12 weeks
Time frame: 2 weeks
Clinical Global Impression 6+ 12 weeks
Time frame: 2 weeks
Severe Impairment Battery 6+12 weeks
Time frame: 2 weeks
Quality of Life 6+12 weeks
Time frame: 2 weeks
Co-meds
Time frame: 2 weeks
Incidents of agitation
Time frame: 2 weeks
Use of rescue protocol
Time frame: 2 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 6 Apr 2022.
- Derived from this study: PubMed 22567095Fox C, Crugel M, Maidment I, Auestad BH, Coulton S, Treloar A, Ballard C, Boustani M, Katona C, Livingston G. Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial. PLoS One. 2012;7(5):e35185. doi: 10.1371/journal.pone.0035185. Epub 2012 May 2.
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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.
CHRIS FOX, MBBSBscMSC principal investigator
KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST
2 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 in people with DEMENTIA, run by East Kent Hospitals University NHS Foundation Trust at 2 sites in United Kingdom.
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 6 inclusion and 14 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. 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?
Cohen-Mansfield (time frame: 2 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 NCT00371059, 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 6 Apr 2022.