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.

ADAS-cog

• 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.

References

1. Scheltens P, et al. Efficacy of a medical food in mild Alzheimer’s disease: A randomized, controlled trial. Alzheimers Dement. 2010;6:1-10.e1.
2. Scheltens P, et al.Efficacy of Souvenaid in mild Alzheimer’s disease: results from a randomized, controlled trial. J Alzheimer’s Dis. 2012;31:225–236.
3. Shah R, et al. Souvenaid® as an add-on intervention in patients with mild to moderate Alzheimer’s Disease using Alzheimer’s Disease medication: results from a randomized, controlled, Double-blind study (S-Connect). CTAD, San Diego, November 2011; J Nutr Health Aging (Nov suppl.).
4. Freund-Levi Y, et al. The LipidiDiet study: rationale and study design. CTAD, San Diego, November 2011; J Nutr Health Aging (Nov suppl.).