Memantine for the Long Term Management of Neuropsychiatric Symptoms in Alzheimer's disease (MAIN-AD)

King's College London (UK)0 个研究点目标入组 300 人开始时间: 2008年2月14日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

King's College London (UK)