Objective: To investigate the clinical and biochemical effects of cholesterol-lowering treatment with Simvastatin in patients with Alzheimer’s disease and vascular dementia.
Design: Open clinical trial with Simvastatin. Patients were followed-up after 3 months and 12 months of Simvastatin treatment.
Materials and Methods: Included in the study were 19 patients with Alzheimer's disease and 13 with vascular dementia. All were diagnosed according to international research criteria, i.e. for Alzheimer's disease, the NINCDS-ADRDA criteria and for vascular dementia, and the NINDS-AIREN criteria. Primary efficacy variables were, for clinical variables, the MMSE and ADAS-cog, and for biochemical variables, cholesterol, triglycerids, HDL, LDL, amyloid in plasma, and betaamyloid-40, betaamyloid-42, alpha-secretase-cleaved APP (alpha-sAPP), beta-secretase-cleaved APP (beta-sAPP), tau, and phospho-tau. The influence of ApoE E4 inheritance was also investigated.
Results: After 3 months, CSF alpha-sAPP and CSF beta-sAPP were significantly reduced (p<0.001), but the CSF levels of tau, phospho-tau, AB42, and the plasma levels of AB were unchanged. The ADAS-cog score was slightly increased (p<0.05). Furthermore, a decrease in total-cholesterol levels was found at 3 months although all patients had normal levels at baseline. The effects of Simvastatin treatment in vascular dementia and the results of 12 months of Simvastatin treatment will also be presented at the IPA Conference.
Conclusion: The results suggest that Simvastatin acts directly on the processing of APP by inhibiting both the alpha- and the beta-secretase pathways at 3 months. The results of 12 months Simvastatin treatment will also be presented and discussed.
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