Status:
COMPLETED
Memantine for Agitation in Dementia
Lead Sponsor:
East Kent Hospitals University NHS Foundation Trust
Collaborating Sponsors:
University of Oxford
Institute of Psychiatry, London
Conditions:
DEMENTIA
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00371059
Start Date
September 1 2007
End Date
September 1 2009
Last Update
April 6 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Oxleas Nhs Foundation Trust
Dartford, KENT, United Kingdom, DA2 7WG
2
Kent and Medway NHS and Social Care Partnership Trust
Folkestone, Kent, United Kingdom, ct20 1jy