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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.

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  • Authors+Show Affiliations

    ,

    Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands. p.scheltens@vumc.nl

    , , , , , , , , , , , ,

    Source

    MeSH

    Aged
    Aged, 80 and over
    Alzheimer Disease
    Antipsychotic Agents
    Cognition Disorders
    Dietary Supplements
    Docosahexaenoic Acids
    Double-Blind Method
    Drug Therapy, Combination
    Eicosapentaenoic Acid
    Electroencephalography
    Europe
    Female
    Follow-Up Studies
    Functional Food
    Humans
    International Cooperation
    Male
    Middle Aged
    Neuropsychological Tests
    Psychiatric Status Rating Scales
    Time Factors
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    22766770

    Citation

    Scheltens, Philip, et al. "Efficacy of Souvenaid in Mild Alzheimer's Disease: Results From a Randomized, Controlled Trial." Journal of Alzheimer's Disease : JAD, vol. 31, no. 1, 2012, pp. 225-36.
    Scheltens P, Twisk JW, Blesa R, et al. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. J Alzheimers Dis. 2012;31(1):225-36.
    Scheltens, P., Twisk, J. W., Blesa, R., Scarpini, E., von Arnim, C. A., Bongers, A., ... Kamphuis, P. J. (2012). Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. Journal of Alzheimer's Disease : JAD, 31(1), pp. 225-36. doi:10.3233/JAD-2012-121189.
    Scheltens P, et al. Efficacy of Souvenaid in Mild Alzheimer's Disease: Results From a Randomized, Controlled Trial. J Alzheimers Dis. 2012;31(1):225-36. PubMed PMID: 22766770.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. AU - Scheltens,Philip, AU - Twisk,Jos W R, AU - Blesa,Rafael, AU - Scarpini,Elio, AU - von Arnim,Christine A F, AU - Bongers,Anke, AU - Harrison,John, AU - Swinkels,Sophie H N, AU - Stam,Cornelis J, AU - de Waal,Hanneke, AU - Wurtman,Richard J, AU - Wieggers,Rico L, AU - Vellas,Bruno, AU - Kamphuis,Patrick J G H, PY - 2012/7/7/entrez PY - 2012/7/7/pubmed PY - 2012/12/10/medline SP - 225 EP - 36 JF - Journal of Alzheimer's disease : JAD JO - J. Alzheimers Dis. VL - 31 IS - 1 N2 - 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. SN - 1875-8908 UR - https://www.unboundmedicine.com/medline/citation/22766770/Efficacy_of_Souvenaid_in_mild_Alzheimer's_disease:_results_from_a_randomized_controlled_trial_ L2 - https://content.iospress.com/openurl?genre=article&id=doi:10.3233/JAD-2012-121189 DB - PRIME DP - Unbound Medicine ER -