Scales used in memantine studies to assess functional ability include:

·            Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) for patients with mild to moderate AD⁹

·            ADCS-ADL_sev – a subscale of the Alzheimer’s Disease Cooperative Study Activities of Daily Living scale – used for patients with moderate to severe AD^9-11

·            care dependency subscale of the Assessment Scale for Geriatric Patients (BGP)¹²

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

·            FAST.⁴

The Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale is designed to assess patients’ function at all stages of AD. It is based on interviews with carers or others close to the patient and focuses on the most usual and consistent performance of ADL over the previous 4 weeks. It is a comprehensive test comprising 45 items with each item including an assessment of performance that ranges from the highest level down to complete loss of function.⁹ However, the author of the scale now recommends using a reduced 23-item scale (ADCS-ADL₂₃). Subsets of the items can also be used depending on the disease severity in the target group, e.g., a 19-item scale (known as ADCS-ADL₁₉ or ADCS-ADL_sev) has been used in the assessment of patients with moderate to severe AD.^10,11 Memantine studies in patients with moderate to severe AD utilised the 19-item scale (ADCS-ADL₁₉), whilst studies in mild to moderate AD utilised the 23-item version (ADCS-ADL₂₃).

Function may also be assessed using the care dependency subscale of the Assessment Scale for Geriatric Patients (BGP)¹² – the largest of the four BGP subscales. It includes 23 items; each item scores from 0–2, and a total score of 46 is the worst result.¹²

The modi?ed D-test (also known as the G-2 test) can be used to assess patient function and behaviour. The test assesses the 16 functional items that are considered to be the most important in maintaining some degree of independence.^13-15 The test is carried out by nursing staff, who assess patients on a 6-point rating scale ranging from normal functioning to total care dependence.¹⁵

The scales used in memantine studies to assess cognitive abilities include:

·            Severe Impairment Battery (SIB)¹⁶

·            cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog)¹⁷

·            cognitive subscale of the BGP.¹²

The Severe Impairment Battery (SIB) has been validated and shown to be reliable and sensitive to changes in cognition over time in patients with severe AD.¹⁶ The SIB was speci?cally developed for the assessment of patients with severe cognitive impairment and is based on simple tasks that use single-step commands presented with gestured cues.^18,19 There are 40 questions in the SIB and a range of scores from 0 (worst result) to 100 (best result).¹⁹

In studies of patients with moderate to severe AD, the SIB was used in preference to the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog), which is not applicable in patients with more severe AD. However, in studies of patients with mild to moderate AD, the ADAS-Cog is the standard assessment of cognition.

In the ?rst clinical study of memantine (MRZ-9403), cognitive function was assessed post-hoc, using a subscale of the BGP (items 10–14).¹²

 

The document about The Alzheimer’s was translated by Huayiwang Mandarin Translation Company.

 

在美金刚研究中，评价的患者功能的量表包括：

·            用于轻中度阿尔茨海默病患者的阿尔茨海默病合作研究-日常生活活动量表(ADCS-ADL)⁹

·            ADCS-ADL_sev–阿尔茨海默病患者的阿尔茨海默病合作研究-日常生活活动量表分量表 – 用于中重度阿尔茨海默病患者^9-11

·            老年行为量表独立性分表(BGP)¹²

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

·            生活功能分期量表⁴

阿尔茨海默病合作研究-日常生活活动量表(ADCS-ADL)用于评价所有阶段阿尔茨海默病患者的功能。该量表基于对患者护理人员或者其他接近患者的人员访谈的结果，该量表主要关注在过去的4周内最常见并且一致的日常生活活动行为。ADCS-ADL为对45个项目的综合评分，每一小项的评分范围自最高分至完全丧失功能⁹。 然而，该量表的作者现在推荐使用精简的23项量表（ADCS-ADL₂₃）。也可以使用各个项目的子集，这取决于目标患者组疾病的严重程度，例如，一个19项的量表（称作ADCS-ADL₁₉ 或者 ADCS-ADL_sev）已被用于对中、重度AD患者进行评价^10,11。 在美金刚治疗中、重度AD患者的研究中，采用19项量表（ADCS-ADL₁₉），而在美金刚治疗轻、中度AD患者的研究中，采用23项量表（ADCS-ADL₂₃）。

也可采用老年患者BGP量表的关怀依赖次级量表对功能进行评价¹²， ― 四个BGP次级量表中最大的量表。该量表包括23项，每项的评分为0-2，最坏结果的总分为46分¹²。

修正的D-test（也称为G-2test）可被用于评价患者的功能及行为。该量表评价16个被认为在维持一定程度独立性中具有重要作用的功能项^13-15。该量表的评价由护理人员执行，护理人员采用6分评定量表对患者进行评价，评分范围自正常功能至全部护理依赖¹⁵。

在美金刚研究中，这些量表被用于评价患者的认知能力，包括：

·         严重损害状态量表(SIB)¹⁶

·         阿尔茨海默病评价量表认知分表(ADAS-Cog)¹⁷

·         老年行为量表认知分表¹²

严重认知损害成套神经心理测验（SIB）量表已被验证，并被证明在一定时间范围内、评价重度AD患者认知功能改变的结果可靠、敏感。¹⁶SIB已被特异性地用于评价严重认知功能损害的患者，该量表基于使用手势提示的单步命令完成的简单任务^18,19。 在SIB量表中，有40个问题，评分范围自0分（最差的结果）至100分（最好的结果）¹⁹。

在对中、重度AD的研究中，SIB量表的使用优先于认知能力评价量表ADAS-Cog，ADAS-Cog量表不适用于更严重的AD患者。然而，在轻、中度AD患者的研究中，ADAS-Cog为标准的认知能力评价量表。

在第一个美金刚临床研究（MRZ-9403）中，采用BGP次级量表（10-14项）对认知功能进行评价¹²。

 

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