Nutricia Welcomes Publication of the LipiDiDiet Clinical Trial Results in Lancet Neurology

Nutricia welcomes publication in Lancet Neurology of the results of the EU funded LipiDiDiet (LDD) study – the first clinical trial to investigate the effects of a medical food in patients with prodromal Alzheimer’s Disease (AD), often referred to as “Mild Cognitive Impairment” (MCI), and considered early stage AD.

As one of the 19 partners in the LDD Consortium, Nutricia is proud that Souvenaid® (containing the key nutrient combination “Fortasyn® Connect”) was selected as the intervention product within the LDD study, on the basis of its results in an earlier EU project (LipiDiet, completed 2000-2005), and other early development work.

These results in patients with MCI support and extend findings from two previous randomized controlled trials of Souvenaid in patients with mild AD. We are pleased that this adds to the body of evidence for Souvenaid and we remain committed to ongoing and further clinical research.

For further details on the LDD study, we suggest you consult any of the following sources:

• To access the LDD study in Lancet Neurology please visit http://www.thelancet.com/journals/lancet/article/PIIS1474-4422(17)30332-0/fulltext?elsca1=tlxpr
• The LipiDiDiet consortium at http://www.lipididiet.eu
• For more information on EU funded projects including LDD, please visit http://cordis.europa.eu/home_en.html

Objective

To investigate the effects of Souvenaid in elderly patients at high risk of developing Alzheimer’s disease.

Primary outcome measures

The primary outcome measure is cognitive performance assessed by a modified version of the Neuropsychological Test Battery (NTB)

Study Design

Patients with prodromal AD defined by Dubois criteria[2]

Primary Outcome:

• Z-score of the NTB (9 item)

Secondary Outcomes:

• Progression to AD
• Cognitive performance (ADAS-Cog, MMSE)
• Functional Ability (ADCS-ADL)
• Depression (MADRS)
• MRI atrophy rate
• Nutritional measures (blood plasma and CSF biomarkers)

The EU-funded LipiDiDiet™ study is a 24-month, randomised, controlled, double-blind, parallel-group, study aiming to recruit 300 prodromal Alzheimer’s disease subjects. Patients will be randomised to receive Souvenaid or an isocaloric control drink. Enrolment for the study is now complete, with first results expected at the end of 2015.

Related Links

• Congress abstract: http://www.ctad.fr/07-download/Congres2011/ABSTRACT_CTAD.pdf.

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References

1.Freund-Levi Y, Visser PJ, Kivipelto M, Wieggers RL, Hartmann T, Soinnen H. The LipiDiDiet study: rationale and study design. CtAD, San Diego, November 2011; J Nutr Health Aging 2011;15 (Suppl 1)

2.Dubois, B., Feldman, H. H., Jacova, C., DeKosky, S. T., Barberger-Gateau, P., Cummings, J., … & Scheltens, P. Research criteria for the diagnosis of Alzheimer’s disease: revising the NINCDS–ADRDA criteria. The Lancet Neurology, 2007;6(8), 734-746.