DOnepezil and Memantine IN mOderate to severe Alzheimer's Disease

Institute of Psychiatry (UK)0 个研究点目标入组 800 人开始时间: 2007年4月4日最近更新: 2018年1月8日

适应症

试验速览

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•Participants will be patients who meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable or possible AD and in addition will meet all of the following criteria:
•1. Continuously prescribed donepezil for at least three months
•2. No change in dosage of donepezil in previous six weeks
•3. No changes in prescription of any psychotropic (antipsychotic, antidepressant, benzodiazepine) medication in previous four weeks
•4. Prescribing clinician considers (based on National Institute of Clinical Excellence [NICE] guidance, discussions with patient and carer and clinical judgement) that change of drug treatment (i.e. stop donepezil or introduce memantine) may be appropriate and Standardised Mini Mental State Exam (SMMSE) = 5 to 13 (13 chosen as NICE threshold of 10 plus 1 SD on SMMSE score)
•5. Patient is community resident and has family or professional carer or is visited on at least a daily basis by carer
•6. Patient agrees to participate where possible
•7. Main carer (informal or institutional) consents to their own involvement

•1. Patient has severe, unstable or poorly controlled medical conditions apparent from physical examination or clinical history
•2. Patient is already prescribed memantine
•3. Patient is unable to take trial medications
•4. Patient is involved in another clinical trial
•5. Patient has absolute contraindication to either donepezil or memantine
•6. Clinician considers patient would not be compliant with medication

发起方

Institute of Psychiatry (UK)