MAGD: Memantine for Agitation in Dementia

Sponsor
East Kent Hospitals University NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00371059
Collaborator
University of Oxford (Other), Institute of Psychiatry, London (Other), University of London (Other), University College, London (Other), Indiana University School of Medicine (Other)
153
Enrollment
2
Locations
24
Actual Duration (Months)
76.5
Patients Per Site
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

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

Study Type:
Interventional
Actual Enrollment :
153 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Actual Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Cohen-Mansfield [2 weeks]

Secondary Outcome Measures

  1. Neuropsychiatric Inventory 6+12 weeks [2 weeks]

  2. Clinical Global Impression 6+ 12 weeks [2 weeks]

  3. Severe Impairment Battery 6+12 weeks [2 weeks]

  4. Quality of Life 6+12 weeks [2 weeks]

  5. Co-meds [2 weeks]

  6. Incidents of agitation [2 weeks]

  7. Use of rescue protocol [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.

  2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4.

  3. Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19).

  4. Clinically significant agitation that requires treatment.

  5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45.

  6. Age >/= 55.

Exclusion Criteria:
  1. Memantine usage in the 4 weeks prior to the start of the study.

  2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.

  3. Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.

  4. Antiparkinsonian medication.

  5. Hypersensitivity to memantine or any of the excipients in the formulation.

  6. Severe renal impairment.

  7. Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.

  8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.

  9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.

  10. Severe, unstable or poorly controlled medical illness.

  11. Any disability that may interfere with the patient completing the study procedure.

  12. Active malignancy.

  13. Delirium, pain or any medical illness as a clear cause of agitation.

  14. 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Oxleas Nhs Foundation TrustDartfordKentUnited KingdomDA2 7WG
2Kent and Medway NHS and Social Care Partnership TrustFolkestoneKentUnited Kingdomct20 1jy

Sponsors and Collaborators

  • East Kent Hospitals University NHS Foundation Trust
  • University of Oxford
  • Institute of Psychiatry, London
  • University of London
  • University College, London
  • Indiana University School of Medicine

Investigators

  • Principal Investigator: CHRIS FOX, MBBSBscMSC, KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
East Kent Hospitals University NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00371059
Other Study ID Numbers:
  • 2005-005087-93
  • ISRCTN 24953404
First Posted:
Sep 1, 2006
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Keywords provided by East Kent Hospitals University NHS Foundation Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022