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


Scheltens, Philip, Twisk, Jos W.R., Blesa, Rafael, Scarpini, Elio, von Arnim, Christine A. F., Bongers, Anke, Harrison, John, Swinkels, Sophie H. N., Stam, Cornelis J., de Waal, Hanneke, Wurtman, Richard J., Wieggers, Rico L., Vellas, Bruno, Kamphuis, Patrick J. G. H.


Journal Of Alzheimer's Disease: JAD, Volume: 31, No.: 1, Pages.: 225-236

Year of Publication



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.;


administration & dosage, aged, aged, 80 and over, alzheimer disease, antipsychotic agents, blood, cognition disorders, complications, diet therapy, dietary supplements, docosahexaenoic acids, double-blind method, drug therapy, drug therapy combination, eicosapentaenoic acid, electroencephalography, etiology, europe, female, functional food, humans, international cooperation, male, middle aged, neuropsychological tests, psychiatric status rating scales, souvenaid, time factors, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Herbal remedies, vitamins, dietary supplements