Souvenir II Open Label Extension
The aim of the Souvenir II Open Label Extension study was to assess safety and adherence to Souvenaid for a further 24 weeks. It also investigated benefits on memory performance in a more “real-world” setting.
The primary outcome measures of the OLE study were safety and product intake adherence. The memory function domain Z-score of the Neuropsychological Test Battery (NTB) was an exploratory parameter.
All patients completing the Souvenir II study, including those previously on placebo, were given the opportunity to take Souvenaid during an additional 24-week period. The use of AD medication was permitted, reflecting standard clinical practice.
- Following the significant improvement on memory performance observed in the Souvenaid II RCT, the OLE study indicated that memory performance continued to improve significantly in patients receiving Souvenaid for up to 48 weeks (p=0.025 for change from 24 to 48 weeks, one-sample t-test)
- In addition, patients who initially received the control product significantly improved on the NTB memory domain scores after starting to use Souvenaid (p=0,008 for change from 24 to 48 weeks, one-sample t-test)
- Compliance was high (96%), which was supported by significant changes in levels of blood nutritional markers, e.g. increased DHA and decreased Homocysteine
- There was not difference in adverse events during the OLE study compared to Souvenir II RCT.
The OLE study demonstrates that Souvenaid continues to improve memory in patients with early Alzheimer’s disease for up to 48 weeks.
The results also confirm that Souvenaid is well tolerated, with a positive safety profile and a high rate of product compliance over 48 weeks.
Souvenir II Open Label Extension study design
All patients completing Souvenir II, including those previously on placebo, received Souvenaid during the Open Label Extension study
Souvenir 2 Open Label Extension baseline characteristics
Baseline characteristics were comparable between groups.
Souvenaid continues to improve memory in patients with early Alzheimer's disease for up to 48 weeks.
The memory performance continued to improve significantly in both active-active and control-active groups.
Souvenaid tolerability profile: all reported adverse events (irrespective of relationship to study product*)
Souvenaid is well tolerated. There was no difference in the incidence of adverse events between Souvenir II study and the Open Label Extension study.
Souvenir II Open Label Extension compliance
Compliance was high (96%) in both groups control-active and active-active.
- 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.