Randomised controlled trial of memantine versus placebo in Parkinson's disease dementia

Manchester Mental Health and Social Care Trust (UK)0 个研究点目标入组 50 人开始时间: 2005年9月14日最近更新: 2015年1月13日

试验速览

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•1. Male and female patients, minimum age of 50.
•2. Have a clinical diagnosis of idiopathic Parkinson?s disease (PD) according to the UK Parkinson?s Disease Society Brain Bank clinical diagnostic criteria (Daniel and Lees, 1993), in the mild to moderate stage as defined by Hoehn and Yahr stage < V (Hoehn and Yahr, 1967).
•3. Have a clinical diagnosis of PDD, according to DSM-IV criteria (Code 294.1), with onset of symptoms of dementia at least 1 year after the first onset of PD motor symptoms.
•4. Have dementia within the range of MMSE 10-26.
•5. Treatment of the motor aspects of the disease stable for at least one month prior to enrolling in the study.
•6. Presence of a reliable caregiver or spouse to act as informant and monitor the study drug.
•7. Stable medical history and general health.
•8. Able to consent to the study, be cooperative, and able to ingest oral medication. Informed consent will be written, however, if the patient is incapable of giving written consent, their legally authorised representative must be able to provide this).

•1. Patients known to have a sensitivity to NMDA receptor antagonists or who are currently on amantadine, ranitidine or cimetidine.
•2. Presence of brain disease other than PD (such as vascular dementia, stroke) or history of neurosurgery.
•3. Presence of severe medical disorders.
•4. A disability that may prevent the patient from completing all study requirements (eg blindness, deafness).
•5. Female patients of child-bearing potential.
•6. Taken any cognitive enhancing agent, such as a cholinesterase inhibitor, during the four weeks prior to randomization.

发起方

Manchester Mental Health and Social Care Trust (UK)