Clinical trial NCT00371059: Memantine for Agitation in Dementia
Official title: Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: DEMENTIA
Keywords: Agitation
Dementia
Alzheimer's
Lead sponsor: East Kent Hospitals University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Oxford
name: Institute of Psychiatry, London
name: University of London
name: University College, London
name: Indiana University School of Medicine
First posted: 2006-09-01
Enrollment: 153
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohen-Mansfield
timeFrame: 2 weeks
Secondary outcomes:
measure: Neuropsychiatric Inventory 6+12 weeks
timeFrame: 2 weeks
measure: Clinical Global Impression 6+ 12 weeks
timeFrame: 2 weeks
measure: Severe Impairment Battery 6+12 weeks
timeFrame: 2 weeks
measure: Quality of Life 6+12 weeks
timeFrame: 2 weeks
measure: Co-meds
timeFrame: 2 weeks
measure: Incidents of agitation
timeFrame: 2 weeks
measure: Use of rescue protocol
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dartford
country: United Kingdom
facility: Oxleas Nhs Foundation Trust
state: Kent
city: Folkestone
country: United Kingdom
facility: Kent and Medway NHS and Social Care Partnership Trust
state: Kent
Study officials:
affiliation: KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST
name: CHRIS FOX, MBBSBscMSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.