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The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study.

Abstract

BACKGROUND

Synaptic loss is a major hallmark of Alzheimer's disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials.

OBJECTIVE

To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD.

DESIGN

A 24-week randomised, controlled, double-blind, parallel-group, multi-country study.

PARTICIPANTS

179 drug-naïve mild AD patients who participated in the Souvenir II study.

INTERVENTION

Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks.

OUTCOME

In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance.

RESULTS

THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance.

CONCLUSIONS

The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG analysis, using the mathematical framework of graph theory, is useful and feasible for assessing the effects of interventions.

TRIAL REGISTRATION

Dutch Trial Register NTR1975.

Links

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  • Authors+Show Affiliations

    ,

    Alzheimer Center & Department of Neurology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.

    ,

    Department of Clinical Neurophysiology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.

    ,

    Nutricia Research, Utrecht, The Netherlands.

    ,

    Nutricia Research, Utrecht, The Netherlands.

    ,

    Nutricia Research, Utrecht, The Netherlands.

    ,

    Alzheimer Center & Department of Neurology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.

    ,

    Laboratory of Cognitive and Computational Neuroscience, UCM-UPM Center for Biomedical Technology, Madrid, Spain.

    Department of Clinical Neurophysiology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands ; Nutricia Research, Utrecht, The Netherlands.

    Source

    PloS one 9:1 2014 pg e86558

    MeSH

    Aged
    Alzheimer Disease
    Brain
    Choline
    Cognitive Dysfunction
    Docosahexaenoic Acids
    Eicosapentaenoic Acid
    Electroencephalography
    Folic Acid
    Food, Formulated
    Humans
    Likelihood Functions
    Middle Aged
    Nerve Net
    Phospholipids
    Regression Analysis
    Selenium
    Synapses
    Treatment Outcome
    Uridine Monophosphate
    Vitamins

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    24475144

    Citation

    de Waal, Hanneke, et al. "The Effect of Souvenaid On Functional Brain Network Organisation in Patients With Mild Alzheimer's Disease: a Randomised Controlled Study." PloS One, vol. 9, no. 1, 2014, pp. e86558.
    de Waal H, Stam CJ, Lansbergen MM, et al. The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study. PLoS ONE. 2014;9(1):e86558.
    de Waal, H., Stam, C. J., Lansbergen, M. M., Wieggers, R. L., Kamphuis, P. J., Scheltens, P., ... van Straaten, E. C. (2014). The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study. PloS One, 9(1), pp. e86558. doi:10.1371/journal.pone.0086558.
    de Waal H, et al. The Effect of Souvenaid On Functional Brain Network Organisation in Patients With Mild Alzheimer's Disease: a Randomised Controlled Study. PLoS ONE. 2014;9(1):e86558. PubMed PMID: 24475144.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study. AU - de Waal,Hanneke, AU - Stam,Cornelis J, AU - Lansbergen,Marieke M, AU - Wieggers,Rico L, AU - Kamphuis,Patrick J G H, AU - Scheltens,Philip, AU - Maestú,Fernando, AU - van Straaten,Elisabeth C W, Y1 - 2014/01/27/ PY - 2013/04/28/received PY - 2013/12/10/accepted PY - 2014/1/30/entrez PY - 2014/1/30/pubmed PY - 2014/11/13/medline SP - e86558 EP - e86558 JF - PloS one JO - PLoS ONE VL - 9 IS - 1 N2 - BACKGROUND: Synaptic loss is a major hallmark of Alzheimer's disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. OBJECTIVE: To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. DESIGN: A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. PARTICIPANTS: 179 drug-naïve mild AD patients who participated in the Souvenir II study. INTERVENTION: Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. OUTCOME: In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance. RESULTS: THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. CONCLUSIONS: The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG analysis, using the mathematical framework of graph theory, is useful and feasible for assessing the effects of interventions. TRIAL REGISTRATION: Dutch Trial Register NTR1975. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/24475144/The_effect_of_souvenaid_on_functional_brain_network_organisation_in_patients_with_mild_Alzheimer's_disease:_a_randomised_controlled_study_ L2 - http://dx.plos.org/10.1371/journal.pone.0086558 DB - PRIME DP - Unbound Medicine ER -