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P3–307: Lower plasma nutrient levels in people with mild Alzheimer's disease compared with healthy volunteers
Author(s) -
Marcel Olde Rikkert,
Sijben J.W.,
Lansink M.,
Scheltens Philip,
Hees Anneke,
Groenendijk M.,
Kamphuis P.
Publication year - 2013
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2013.05.1382
Subject(s) - medicine , confounding , micronutrient , anthropometry , docosahexaenoic acid , polyunsaturated fatty acid , disease , vitamin e , gastroenterology , physiology , fatty acid , endocrinology , antioxidant , biology , biochemistry , pathology
memory performance in drug-na€ive mild AD patients (MMSE 20-26 and MMSE 20), indicating that Souvenaid is efficacious in the early phases of AD. The ’LipiDiDiet’ study 2 is one of the first RCTs in prodromal AD, investigating the effects of Souvenaid on cognition.Methods: The LipiDiDiet study is an ongoing 24-month, double-blind, parallel-group RCT investigating the effects of Souvenaid in 300 prodromal AD subjects (criteria Dubois, 2007). Subjects are randomly assigned to Souvenaid or an iso-caloric control product. Primary outcome measure is cognitive functioning, assessed by a modified version of the Neuropsychological Test Battery (Harrison, 2007). Secondary outcome measures include progression to AD, cognitive performance, functional abilities (ADCS-ADL), depression (MADRS), MRI atrophy rate, plasma and CSF biomarkers, safety, tolerance and nutritional parameters. Main study outcomes are assessed at baseline and after 6, 12 and 24 months of intervention. Baseline characteristics of the study population are analyzed.Results: Preliminary analysis of baseline data from 213 randomized subjects (47.9% male, enrolled until July 2012) showed that subjects had a mean age of 71.866.9 years, MMSE score of 26.662.0 and ADAS-cog score of 19.767.8. Baseline biomarker data from a subsample of subjects (n1⁄422) showed a CSF b-amyloid 1-42/ 1-40x10 ratio of 1.8960.71, CSF total tau of 465.56269.6 pg/ml, CSF phosphorylated tau of 74.5635.6 pg/ml and MTA score of 1.6461.00 (MRI evidence for medial temporal lobe atrophy). Last subject randomized in the study is expected early 2013. Therefore, baseline characteristics of the total study population will be presented at the conference. Conclusions: Baseline characteristics of the study population included in the LipiDiDiet study so far are as expected for subjects with prodromal AD.