Alzheimer's disease Nervous System Diseases Alzheimer's disease
Conditions
Interventions
Intervention group: Memantine + placebo neuroleptic for 24 weeks
Control group: Neuroleptic + placebo memantine for 24 weeks
The choice of neuroleptic and dose will be made by the responsible clinici
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Living in a nursing or social care facilities 2. Fulfill the National Institute of Neurological and Communication Disorders and Stroke/ Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for possible or probable Alzheimer's Disease (AD) 3. Taking at least 0.5 mg daily of haloperidol, 0.5 mg daily of risperidone, 5 mg daily of olanzapine or 25 mg daily of quetiapine or another neuroleptic which in the opinion of the responsible clinician could be safely converted to one of these neuroleptics, for a minimum of 3 months prior to entry into the study 4. If taking a cholinesterase inhibitor, prescribed for at least 6 months before the date of assessment, with a stable dose for at least 3 months 5. Not taking anticonvulsants other than carbamazepine or sodium valproate. The use of either of these 2 agents is permissible if the dose has been stable for at least 4 weeks 6. If taking any other psychotropic drugs (e.g., antidepressants, benzodiazepines, chlormethiazole), the dose has been stable for at least 4 weeks prior to randomization 7. Have not received memantine in the last 6 weeks 8. Taking any medications that are contra-indicated or not recommended in combination with memantine, as defined in the British National Formulary, including ketamine, dextromethorphan and amantidine 9. Written informed consent provided by the participant (if they have capacity) and/or their next of kin or a legal representative
Exclusion criteria
Exclusion criteria: 1. Current evidence of delirium 2. Moderately severe renal impairment, as measured by or equivalent to an estimated creatinine clearance of <50 mL/min/1.73 m2 3. Severe hepatic impairment 4. Unable to swallow tablets or capsules 5. Low probability of treatment compliance 6. Currently taking memantine 7. Previous evidence of lack of efficacy or tolerability to memantine 8. Taking any of the following substances: 8.1. An investigational drug during the 4 weeks prior to randomization 8.2. A drug known to cause major organ system toxicity during the 4 weeks prior to randomization. 8.3. Started any new psychotropic medication during the 4 weeks prior to randomization. Participants who have been on a stable dose of psychotropic during the 4 weeks prior to randomization are still eligible 8.4. Memantine during the 6 weeks prior to randomization 8.5. Other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, and dextromethorphan. 8.6. Barbiturates and primidone 8.7. Baclofen and dantrolen 8.8. Dextromethorphan 8.9. Antimuscarinics 8.10. Anticonvulsants other than sodium valproate or carbamazepine. These 2 agents are permissible if doses have been stable for at least 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following will be assessed at baseline, week 6, week 12 and week 24: 1. Bristol Activities of Daily Living scale. Please note that only the week 24 outcome will be considered as the primary outcome. 2. Cohen-Mansfield agitation inventory. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at baseline, week 6, week 12 and week 24: 1. Neuropsychiatric inventory 2. Severe impairment battery 3. Mini-mental state examination 4. Letter fluency (FAS) test 5. Functional assessment staging 6. Modified D test 7. Clinical global impression of change 8. Modified unified Parkinson's disease rating scale 9. Abnormal involuntary movement scale | — |
Countries
United Kingdom
Outcome results
None listed