DEMENTIA
Conditions
Keywords
Agitation, Dementia, Alzheimer's
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.
Interventions
DRUGMemantine
Memantine 10mg BD
DRUGPlacebo
Placebo 10 mgs BD
Sponsors
University of Oxford
Institute of Psychiatry, London
University of London
University College, London
Indiana University School of Medicine
East Kent Hospitals University NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohen-Mansfield | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychiatric Inventory 6+12 weeks | 2 weeks |
| Clinical Global Impression 6+ 12 weeks | 2 weeks |
| Severe Impairment Battery 6+12 weeks | 2 weeks |
| Quality of Life 6+12 weeks | 2 weeks |
| Co-meds | 2 weeks |
| Incidents of agitation | 2 weeks |
| Use of rescue protocol | 2 weeks |
Countries
United Kingdom
Outcome results
None listed