Tolerability and Safety of Souvenaid in Patients with Mild Alzheimer’s Disease: Results of Multi-Center, 24-Week, Open-Label Extension Study
Open accessAbstract
BACKGROUND: The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. OBJECTIVE: In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. METHODS: Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. RESULTS: Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. CONCLUSION: Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.
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The multicenter clinical trial of Souvenaid in mild AD patients showed preliminary suggestion of continued improvement in memory performance.
“The study showed preliminary suggestion of continued improvement in memory performance.”
From Role of Oxidative Damage in Alzheimer’s Disease and Neurodegeneration: From Pathogenic Mechanisms to Biomarker Discovery (2021) · cites this paper as [160]
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- Authors
- Olde Rikkert, M. G. M., Verhey, F. R., Blesa, R., von Arnim, C. A. F., Bongers, A., Harrison, J., Sijben, J., Scarpini, E., Vandewoude, M. F. J., Vellas, B., Witkamp, R., Kamphuis, P. J. G. H., & Scheltens, P.
- Affiliations
- Radboud Alzheimer Centre, Department of Geriatric Medicine, Radboud University Hospital, Nijmegen, The Netherlands
- Maastricht University Medical Centre (NL)
- Hospital de Sant Pau (ES)
- Department of Neurology, Ulm University, Ulm, Germany
- Nutricia Research (Netherlands) (NL)
- Imperial College London (GB)
- University of Milan (IT)
- University of Antwerp (BE)
- Inserm (FR)
- Wageningen University & Research (NL)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- ORCID
- Venue
- Journal of Alzheimer s Disease
- Publisher
- SAGE Publications
- Published
- 2015-01-22
- Volume
- 44
- Issue
- 2
- Pages
- 471-480
- ISSN
- 1387-2877 (ISSN-L)
- 1875-8908
- OpenAlex
- W1547180086
- Cited by
- 61
- References
- 30
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 4 · 2023: 5 · 2022: 1 · 2021: 3 · 2020: 6 · 2019: 7 · 2018: 5 · 2017: 6 · 2016: 10 · 2015: 8
- FWCI
- 7.12
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Alzheimer s Disease (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Pure Amsterdam UMC (acceptedVersion, other-oa)
- Socio-Environmental Systems Modeling (acceptedVersion, cc-by-nc)
- Radboud Repository (Radboud University) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, cc-by-nc)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neurological Disorders and Treatments
- Keywords
- Souvenaid
- MeSH terms
- Aged, Alzheimer Disease, Beverages, Docosahexaenoic Acids, Double-Blind Method, Erythrocytes, Fatty Acids, Female, Food, Formulated, Humans, Male, Memory, Neuropsychological Tests, Patient Compliance, Vitamin E, Treatment Outcome, Nootropic Agents
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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