Tolerability and safety of souvenaid in patients with mild Alzheimer's disease: Results of multi-center, 24-week, open-label extension study

Marcel G.M. Olde Rikkert, Frans R. Verhey, Rafael Blesa, Christine A.F. Von Arnim, Anke Bongers, John Harrison, John Sijben, Elio Scarpini, Maurits F.J. Vandewoude, Bruno Vellas, Renger Witkamp, Patrick J.G.H. Kamphuis, Philip Scheltens

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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.

Original languageEnglish
Pages (from-to)471-480
Number of pages10
JournalJournal of Alzheimers Disease
Volume44
Issue number2
DOIs
Publication statusPublished - 2015

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Alzheimer Disease
Randomized Controlled Trials
Safety
Food
Neuropsychological Tests
Synapses
Cognition
Control Groups
Incidence
Pharmaceutical Preparations

Keywords

  • Alzheimer's disease
  • clinical trial
  • dietary management
  • intervention studies
  • long-term
  • medical nutrition therapy
  • memory
  • patient adherence
  • safety

Cite this

Olde Rikkert, M. G. M., Verhey, F. R., Blesa, R., Von Arnim, C. A. F., 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 Alzheimers Disease, 44(2), 471-480. https://doi.org/10.3233/JAD-141305
Olde Rikkert, Marcel G.M. ; Verhey, Frans R. ; Blesa, Rafael ; Von Arnim, Christine A.F. ; Bongers, Anke ; Harrison, John ; Sijben, John ; Scarpini, Elio ; Vandewoude, Maurits F.J. ; Vellas, Bruno ; Witkamp, Renger ; Kamphuis, Patrick J.G.H. ; Scheltens, Philip. / Tolerability and safety of souvenaid in patients with mild Alzheimer's disease : Results of multi-center, 24-week, open-label extension study. In: Journal of Alzheimers Disease. 2015 ; Vol. 44, No. 2. pp. 471-480.
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title = "Tolerability and safety of souvenaid in patients with mild Alzheimer's disease: Results of multi-center, 24-week, open-label extension study",
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-na{\"i}ve 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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author = "{Olde Rikkert}, {Marcel G.M.} and Verhey, {Frans R.} and Rafael Blesa and {Von Arnim}, {Christine A.F.} and Anke Bongers and John Harrison and John Sijben and Elio Scarpini and Vandewoude, {Maurits F.J.} and Bruno Vellas and Renger Witkamp and Kamphuis, {Patrick J.G.H.} and Philip Scheltens",
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Olde Rikkert, MGM, Verhey, FR, Blesa, R, Von Arnim, CAF, Bongers, A, Harrison, J, Sijben, J, Scarpini, E, Vandewoude, MFJ, Vellas, B, Witkamp, R, Kamphuis, PJGH & 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 Alzheimers Disease, vol. 44, no. 2, pp. 471-480. https://doi.org/10.3233/JAD-141305

Tolerability and safety of souvenaid in patients with mild Alzheimer's disease : Results of multi-center, 24-week, open-label extension study. / Olde Rikkert, Marcel G.M.; Verhey, Frans R.; Blesa, Rafael; Von Arnim, Christine A.F.; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F.J.; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J.G.H.; Scheltens, Philip.

In: Journal of Alzheimers Disease, Vol. 44, No. 2, 2015, p. 471-480.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Tolerability and safety of souvenaid in patients with mild Alzheimer's disease

T2 - 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 - 2015

Y1 - 2015

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.

AB - 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.

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

U2 - 10.3233/JAD-141305

DO - 10.3233/JAD-141305

M3 - Article

VL - 44

SP - 471

EP - 480

JO - Journal of Alzheimers Disease

JF - Journal of Alzheimers Disease

SN - 1387-2877

IS - 2

ER -