È uno studio multicentrico, randomizzato, in doppio cieco controllato, gruppi paralleli in cui Souvenaid è stato

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Virgilio Martelli
8 anni fa
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1 Souvenir 1 Alzheimers Dement Jan;6(1):1-10.e1. doi: /j.jalz È uno studio multicentrico, randomizzato, in doppio cieco controllato, gruppi paralleli in cui Souvenaid è stato somministrato una volta al giorno vs placebo nei pazienti con malattia di alzheimer in fase iniziale della durata di 12 settimane. Souvenaid ha dimostrato di migliorare la memoria nei pazienti affetti da malattia di Alzheimer in fase iniziale nelle 12 settimane di trattamento con un profilo di tollerabilità paragonabile al placebo e compliance al trattamento superiore al 97% Miglioramento del test di memoria verbale differita (WMS-r) a 12 settimane Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial. Scheltens P, Kamphuis PJ, Verhey FR, Olde Rikkert MG, Wurtman RJ, Wilkinson D, Twisk JW, Kurz A. VU University Medical Center, Amsterdam, The Netherlands. p.scheltens@vumc.nl Abstract OBJECTIVE: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). METHODS: A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a control drink, taken once-daily for 12 weeks. Primary outcome measures were the delayed verbal recall task of the Wechsler Memory Scale-revised, and the 13-item modified Alzheimer's Disease Assessment Scale-cognitive subscale at week 12.

fase iniziale della durata di 12 settimane.

2 RESULTS: At 12 weeks, significant improvement in the delayed verbal recall task was noted in the active group compared with control (P =.021). Modified Alzheimer's Disease Assessment Scale-cognitive subscale and other outcome scores (e.g., Clinician Interview Based Impression of Change plus Caregiver Input, 12-item Neuropsychiatric Inventory, Alzheimer's disease Co-operative Study-Activities of Daily Living, Quality of Life in Alzheimer's Disease) were unchanged. The control group neither deteriorated nor improved. Compliance was excellent (95%) and the product was well tolerated. CONCLUSIONS: Supplementation with a medical food including phosphatide precursors and cofactors for 12 weeks improved memory (delayed verbal recall) in mild AD patients. This proof-of-concept study justifies further clinical trials The Alzheimer's Association. All rights reserved. PMID: [PubMed - indexed for MEDLINE]

itive subscale and other outcome scores (e.g.

3 Souvenir 2 J Alzheimers Dis. 2012;31(1): doi: /JAD È uno studio multicentrico, randomizzato, in doppio cieco controllato, gruppi paralleli in cui Souvenaid è stato somministrato una volta al giorno vs placebo nei pazienti con malattia di alzheimer in fase iniziale della durata di 24 settimane. Souvenaid ha dimostrato di migliorare la memoria nei pazienti affetti da malattia di Alzheimer in fase iniziale nelle 24 settimane di trattamento con un profilo di tollerabilità paragonabile al placebo e compliance al trattamento superiore al 97% Significativo miglioramento della memoria - punteggio NTB Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. Scheltens P, Twisk JW, Blesa R, Scarpini E, von Arnim CA, Bongers A, Harrison J, Swinkels SH, Stam CJ, de Waal H, Wurtman RJ, Wieggers RL, Vellas B, Kamphuis PJ. Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands. p.scheltens@vumc.nl 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

fase iniziale della durata di 24 settimane.

4 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. PMID: [PubMed - indexed for MEDLINE]

Compliance was very high (96.6% [control] and 97.1% [active]). No difference between study groups in the occurrence of (serious) adverse events.

5 Journal of Alzheimer's Disease 31 (2012) DOI /JAD IOS Press. 237 Editoriale tratto dallo studio Souvenir II firmato dal prof. J. Cummings Food for thought: Souvenaid in Mild Alzheimer's Disease. Jeffrey L. Cummings* From the Cleveland Clinic Lou Ruvo Center for Brain Health, Neurological Institute, Las Vegas, NV, Cleveland, OH, Weston, FL, USA Souvenaid ha dimostrato di avere effetto sull'integrità sinaptica, come proposto dai ricercatori dello studio Souvenaid II, tale effetto può non essere limitato all'ad. I risultati dello studio Souvenaid II sono convincenti per giustificare ulteriori studi nella AD e per prendere in considerazione la possibilità di testare Souvenaid in altre patologie (Malattia di Parkinson, trauma cranico, ictus, ecc.) Cleveland Clinic Lou Ruvo Center for Brain Health, Neurological Institute, Las Vegas, NV 89106, USA. Cumminj@ccf.org PMID: [PubMed - indexed for MEDLINE]

Cummings* From the Cleveland Clinic Lou Ruvo Center for Brain Health, Neurological Institute, Las Vegas, NV, Cleveland, OH, Weston, FL, USA Souvenaid ha dimostrato di avere effetto sull'integrità

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