We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the
acute situation i.e under 12 weeks
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Drug : Memantine, Drug : Placebo
Study Arm Groups : ,
See Interventions above
- 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
Sorry, this information is not available
This is available on the Clinicaltrials.gov
55 Years - N/A
- 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
- 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
- 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.
This is in the inclusion criteria above
Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Not available for this trial
- 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