Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial

P Scheltens, JWR Twisk, R Blesa… - Journal of …, 2012 - content.iospress.com
P Scheltens, JWR Twisk, R Blesa, E Scarpini, CAF von Arnim, A Bongers, J Harrison
Journal of Alzheimer's Disease, 2012content.iospress.com
Souvenaid aims to improve synapse formation and function. An earlier study in patients with
Alzheimer's disease (AD) showed that Souvenaid increased memory performance after 12
weeks in drug-naıve patients with mild AD. The Souvenir II study was a 24-week,
randomized, controlled, double-blind, parallel-group, multi-country trial to confirm and
extend previous findings in drug-naıve patients with mild AD. Patients were randomized 1: 1
to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. The primary …
Abstract
Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer’s disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naıve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind, parallel-group, multi-country trial to confirm and extend previous findings in drug-naıve patients with mild AD. Patients were randomized 1: 1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. The primary outcome was the memory function domain Z-score of the Neuropsychological Test Battery (NTB) over 24 weeks. Electroencephalography (EEG) measures served as secondary outcomes as marker for synaptic connectivity. Assessments were done at baseline, 12, and 24 weeks. The NTB memory domain Z-score was significantly increased in the active versus the control group over the 24-week intervention period (p= 0.023; Cohen’sd= 0.21; 95% confidence interval [− 0.06]–[0.49]). A trend for an effect was observed on the NTB total composite z-score (p= 0· 053). EEG measures of functional connectivity in the delta band were significantly different between study groups during 24 weeks in favor of the active group.
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