Mini Mental State Examination (MMSE)
- A widely-used and well-validated assessment of general cognitive function, often used to follow the course of cognitive changes in an individual over time. Scores range from 0 to 30 decreasing as Alzheimer’s disease progresses
Wechsler Memory Scale-revised (WMS-r)
- A widely-used, well-validated test of different types of memory
- Made up of several subtests: Spatial Addition, Symbol Span, Design Memory, General Cognitive Screener, Verbal Memory, Verbal Paired Associates, and Visual Reproduction
- Performance is reported as five Index Scores: Auditory Memory, Visual Memory, Visual Working Memory, Immediate Memory and Delayed Memory
Why was WMS-r used in Souvenir I?
The WMS-r provides a sensitive assessment of episodic memory, which is affected early in Alzheimer’s disease . It gives a measure of immediate and delayed verbal memory, and it is widely used in clinical assessment and research settings.
Neuropsychological Test Battery (NTB)
- A collection of standardised and well-validated tests chosen to assess different areas of cognition
- In the Souvenir II trial, the NTB used was based on one shown to be sensitive in patients with mild Alzheimer’s disease, consisting of the following cognitive tasks:
Memory domain score
- Rey Auditory Verbal Learning Test (RAVLT): immediate, delayed and recognition
- WMS: immediate and delayed verbal paired association
Why was the NTB used as the primary endpoint in the Souvenir II trial?
The NTB allows a detailed assessment of different areas of cognition and is sensitive to early cognitive changes. The components are standardised, well-validated, and widely used in both clinical trials and clinical assessment.
- The cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS), which was developed and validated for assessing cognitive functioning in patients with Alzheimer’s disease
- The standard test includes 11 items designed measures different cognitive domains:
Memory and new learning (4 items)
Language (5 items)
Praxis (2 items)
- The 13 item version also includes two tests assessing executive function: delayed verbal recall and digit cancellation
- Scores range from 0-85 with lower scores indicating better functioning
Why was ADAS-cog used in Souvenir?
The ADAS-cog has been widely used in clinical trials over many years, and is generally considered to be the ‘gold-standard’ assessment of cognitive function. It was developed specifically for patients with Alzheimer’s disease and the modified version includes assessment of the key domains that are typically affected in mild- to-moderate stages of the disease.
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