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Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.
J Alzheimers Dis 2015; 44(2):471-80JA

Abstract

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.

Authors+Show Affiliations

Radboud Alzheimer Centre, Department of Geriatric Medicine, Radboud University Hospital, Nijmegen, The Netherlands.Alzheimer Centre Limburg, Maastricht University Medical Centre, Maastricht, The Netherlands.Department of Neurology, Hospital de la Sta Creu i St. Pau, Barcelona, Spain.Department of Neurology, Ulm University, Ulm, Germany.Nutricia Advanced Medical Nutrition, Nutricia Research, Utrecht, The Netherlands.Metis Cognition Ltd, Kilmington, UK & Imperial College, London, UK.Nutricia Advanced Medical Nutrition, Nutricia Research, Utrecht, The Netherlands.University of Milan, Fondazione Cà Granda, IRCCS Ospedale Policlinico, Milan, Italy.University Department of Geriatrics, Antwerp Hospital Network (ZNA St Elisabeth), University of Antwerp, Belgium.Gerontopole, INSERM U 1027, Toulouse, France.Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.Nutricia Advanced Medical Nutrition, Nutricia Research, Utrecht, The Netherlands.Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25322923

Citation

Olde Rikkert, Marcel G M., et al. "Tolerability and Safety of Souvenaid in Patients With Mild Alzheimer's Disease: Results of Multi-center, 24-week, Open-label Extension Study." Journal of Alzheimer's Disease : JAD, vol. 44, no. 2, 2015, pp. 471-80.
Olde Rikkert MG, Verhey FR, Blesa R, et al. Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study. J Alzheimers Dis. 2015;44(2):471-80.
Olde Rikkert, M. G., Verhey, F. R., Blesa, R., von Arnim, C. A., Bongers, A., Harrison, J., ... Scheltens, P. (2015). Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study. Journal of Alzheimer's Disease : JAD, 44(2), pp. 471-80. doi:10.3233/JAD-141305.
Olde Rikkert MG, et al. Tolerability and Safety of Souvenaid in Patients With Mild Alzheimer's Disease: Results of Multi-center, 24-week, Open-label Extension Study. J Alzheimers Dis. 2015;44(2):471-80. PubMed PMID: 25322923.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study. AU - Olde Rikkert,Marcel G M, AU - Verhey,Frans R, AU - Blesa,Rafael, AU - von Arnim,Christine A F, AU - Bongers,Anke, AU - Harrison,John, AU - Sijben,John, AU - Scarpini,Elio, AU - Vandewoude,Maurits F J, AU - Vellas,Bruno, AU - Witkamp,Renger, AU - Kamphuis,Patrick J G H, AU - Scheltens,Philip, PY - 2014/10/18/entrez PY - 2014/10/18/pubmed PY - 2015/9/22/medline KW - Alzheimer's disease KW - clinical trial KW - dietary management KW - intervention studies KW - long-term KW - medical nutrition therapy KW - memory KW - patient adherence KW - safety SP - 471 EP - 80 JF - Journal of Alzheimer's disease : JAD JO - J. Alzheimers Dis. VL - 44 IS - 2 N2 - 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. SN - 1875-8908 UR - https://www.unboundmedicine.com/medline/citation/25322923/Tolerability_and_safety_of_Souvenaid_in_patients_with_mild_Alzheimer's_disease:_results_of_multi_center_24_week_open_label_extension_study_ L2 - https://content.iospress.com/openurl?genre=article&id=doi:10.3233/JAD-141305 DB - PRIME DP - Unbound Medicine ER -