The scales used in memantine studies to assess behaviour include:

·            Neuropsychiatric Inventory (NPI)²⁰

·            Modi?ed D-test (also called the G-2 test)^13-15

·            Assessment Scale for Geriatric patients (BGP).¹²

The Neuropsychiatric Inventory (NPI) scores patients’ behaviour on a number of subscales, including delusions, hallucinations, agitation/aggression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, and aberrant motor activity.²⁰ The scores are determined by an interview with the carer. A score for the severity and frequency of each item is determined, and the score for each subscale is calculated by multiplying the total severity score by the total frequency score. The total NPI score is the sum of the total subscale scores. The NPI also includes a subjective caregiver stress assessment for each subscale on a scale of 0–5.²⁰

Other measures of behaviour used in memantine studies include behavioural assessments from the modi?ed D-test, and the BGP scale.

The Resource Utilisation in Dementia (RUD) instrument quanti?es resources used and carer burden. The RUD instrument is based on structured interviews with carers during which they are asked about the time they spend caring for people with AD, their work status and time lost through caring for the patient, the patient’s residential status, and the use of healthcare resources by themselves and the people they look after.²¹

Two further scales assessing various aspects of cognition, function and behaviour, were used in a memantine post-marketing study described later in this section:

·            Nurses’ Observation Scale for Geriatric Patients (NOSGER)²²

·            Explorations Modul Demenz (EMD).²³

The Nurses’ Observation Scale for Geriatric Patients (NOSGER) is a rating scale for use in geriatric patients that can be applied by nurses or other caregivers. It deals with the daily behaviour and function of elderly patients and measures impairment in six areas (dimensions): memory; instrumental activities of daily living (IADL); (basic) activities of daily living (ADL); mood; social behaviour; and disturbing behaviour.

The Explorations Modul Demenz (EMD) is a psychometric questionnaire that is performed by the patient and by the caregiver. It employs 13 simple closed questions to assess various aspects of cognition, function and insight. The responses are used to generate a self-evaluation, as well as an objective evaluation of the patient’s condition.

In order to derive meaningful conclusions from the extensive data obtained in the memantine clinical studies, various statistical analysis techniques have been employed to identify the statistical signi?cance of the results. Some of these techniques, and the reasons for their use, are outlined below.

 

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在美金刚研究中所使用的行为量表包括：

·            神经精神症状问卷²⁰

·            修正的D-test（也称为G-2 test）^13-15

·            老年行为量表¹²

神经精神症状问卷（NPI）对患者的许多行为细项进行评分，包括妄想、幻觉、激动/攻击、焦虑、情绪高涨/欣快、情感淡漠/冷淡、去抑制、易激惹/情绪不稳定及异常的运动活动²⁰。通过与患者护理人员访谈对患者进行评分，对严重程度进行评分，并确定每一项的发生频率，每一次级量表项的评分为：总严重程度评分乘以总发生频率评分。总BPI评分为各项次级量表评分的总和。NPI量表也包括对每个次级量表项主观的照护者压力评价，评分范围为0-5分²⁰。

在美金刚研究中，其他的行为评价量表包括修正的D-test行为评价及BGP量表行为评价。

痴呆患者资源利用（RUD）量表对所使用的资源及护理人员的负担进行定量。RUD量表基于对患者护理人员的结构性访谈结果，在这一过程中，护理人员将被问及照顾AD患者所花的时间、他们的工作状况及照顾患者过程中的时间损失、患者的居住状况、护理人员使用医疗保健资源的情况及他们所护理的AD患者使用医疗保健资源的情况²¹。

两个进一步对认知能力、功能及行为各个方面进行评价的量表被用于后面章节所描述的美金刚上市后研究中。

·         老年患者护士观察量表²²

^·          EMD ²³

老年患者护士观察量表（NOSGER）为一个用于老年患者的分级评定量表，该量表供护士或者其他护理人员使用。该量表对日常行为及老年患者的功能进行评价，并对六个方面的损害进行评分：记忆、工具性日常生活活动（IADL）；（基本的）日常生活活动；情绪；社会行为；以及滋扰行为。

EMD 为一个心理测验调查问卷，该问卷由患者及患者的护理人员完成。该问卷包含13个简单的封闭性问题，以对认知能力、功能及自知力的各个方面进行评价。应答的结果被用于患者的自我评价，以及患者状况的客观评价。

为了从美金刚临床研究大量的数据中获得有意义的结论，采用了各种统计方法以证实临床研究结果的统计学意义。在下面列举了一些所采用的统计方法及采用这些统计方法的原因。

 

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