title: Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial.
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-naïve 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-naïve 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's d = 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. Compliance was very high (96.6% [control] and 97.1% [active]). No difference between study groups in the occurrence of (serious) adverse events. This study demonstrates that Souvenaid is well tolerated and improves memory performance in drug-naïve patients with mild AD. EEG outcomes suggest that Souvenaid has an effect on brain functional connectivity, supporting the underlying hypothesis of changed synaptic activity.
authors: Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands. p.scheltens@vumc.nl
authors: Philip
authors: P
authors: Scheltens
authors: Jos W R
authors: JW
authors: Twisk
authors: Rafael
authors: R
authors: Blesa
authors: Elio
authors: E
authors: Scarpini
authors: Christine A F
authors: CA
authors: von Arnim
authors: Anke
authors: A
authors: Bongers
authors: John
authors: J
authors: Harrison
authors: Sophie H N
authors: SH
authors: Swinkels
authors: Cornelis J
authors: CJ
authors: Stam
authors: Hanneke
authors: H
authors: de Waal
authors: Richard J
authors: RJ
authors: Wurtman
authors: Rico L
authors: RL
authors: Wieggers
authors: Bruno
authors: B
authors: Vellas
authors: Patrick J G H
authors: PJ
authors: Kamphuis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D003072:Cognition Disorders / Q000178:diet therapy / Q000209:etiology; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000008:administration & dosage / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage; D004569:Electroencephalography; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D055951:Functional Food; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid