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Human Albumin Grifols ® 5% in plasmapheresis: a new therapy involving beta-amyloid mobilisation in Alzheimer’s disease
INTRODUCTION AND AIMS. Results from a pilot study and its 2-year extension (IG0502) performed on patients with mild or moderate Alzheimer’s disease revealed a tendency towards clinical stabilization after a plasmapheresis program with plasma exchange with therapeutic albumin Human Albumin Grifols ® 5%. Plasma levels of Aß(40) and Aß(42) presented a saw-tooth pattern associated to plasma exchanges. These findings encouraged a new randomized, controlled, parallel, blind study (IG0602) to confirm our previous working hypotheses, i.e. that Aß(40) and Aß(42) concentrations in plasma were modified pre- and post plasmapheresis with Human Albumin Grifols ® 5% and, in the clinical area, that the cognitive capabilities of patients could be stabilized or even improved. Other aims of the study were focused on neuroimaging evaluation of structural and functional changes in the brain the by means of magnetic resonance and single-photon emission computerised tomography.
RESULTS. Preliminary results from the randomized study carried out after a follow-up of one year of the first 29 patients (80% of the recruited) show a clear difference between the treated and the control groups with regard to the levels of Aß(40), both in plasma and in cerebrospinal fluid, that are associated with the plasma exchanges. This pattern is not so evident for Aß(42). Regarding cognitive performance, the treated group scored better than the control group after the period study, according to the evaluation performed by using the Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) tests.