title: Efficacy and Safety of Plasma Exchange with 5% Albumin to Modify Cerebrospinal Fluid and Plasma Amyloid-β Concentrations and Cognition Outcomes in Alzheimer's Disease Patients: A Multicenter, Randomized, Controlled Clinical Trial.
abstract: Studies conducted in animal models and humans suggest the presence of a dynamic equilibrium of amyloid-β (Aβ) peptide between cerebrospinal fluid (CSF) and plasma compartments.
  
  
  
  To determine whether plasma exchange (PE) with albumin replacement was able to modify Aβ concentrations in CSF and plasma as well as to improve cognition in patients with mild-moderate Alzheimer's disease (AD).
  
  
  
  In a multicenter, randomized, patient- and rater-blind, controlled, parallel-group, phase II study, 42 AD patients were assigned (1 : 1) to PE treatment or control (sham) groups. Treated patients received a maximum of 18 PE with 5% albumin (Albutein®, Grifols) with three different schedules: two PE/weekly (three weeks), one PE/weekly (six weeks), and one PE/bi- weekly (12 weeks), plus a six-month follow-up period. Plasma and CSF Aβ1-40 and Aβ1-42 levels, as well as cognitive, functional, and behavioral measures were determined.
  
  
  
  CSF Aβ1-42 levels after the last PE compared to baseline were marginally higher in PE-treated group versus controls (adjusted means of variation: 75.3 versus -45.5 pg/mL; 95% CI: -19.8, 170.5 versus 135.1, 44.2; p = 0.072). Plasma Aβ1-42 levels were lower in the PE-treated group after each treatment period (p < 0.05). Plasma Aβ1-40 levels showed a saw-tooth pattern variation associated with PE. PE-treated patients scored better in the Boston Naming Test and Semantic Verbal Fluency (p < 0.05) throughout the study. Neuropsychiatric Inventory scores were higher in controls during the PE phase (p < 0.05).
  
  
  
  PE with human albumin modified CSF and plasma Aβ1-42 levels. Patients treated with PE showed improvement in memory and language functions, which persisted after PE was discontinued.
authors.affiliation: Memory Clinic and Research Center of Fundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain.|Neurology Service, Hospital General Universitari Vall d'Hebron, Barcelona, Spain.
authors.forename: Mercè
authors.initials: M
authors.lastname: Boada
authors.affiliation: Nephrology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Anaya
authors.affiliation: Banc de Sang i Teixits, Barcelona, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Ortiz
authors.affiliation: Neurology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Olazarán
authors.affiliation: Alzheimer's Research Corporation, Mid Atlantic Geriatric Association, Manchester, NJ, USA.
authors.forename: Joshua R
authors.initials: JR
authors.lastname: Shua-Haim
authors.affiliation: Department of Internal Medicine, Howard University, Washington, DC, USA.
authors.forename: Thomas O
authors.initials: TO
authors.lastname: Obisesan
authors.affiliation: Memory Clinic and Research Center of Fundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Hernández
authors.affiliation: Banc de Sang i Teixits, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Muñoz
authors.affiliation: Memory Clinic and Research Center of Fundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain.
authors.forename: Mar
authors.initials: M
authors.lastname: Buendia
authors.affiliation: Memory Clinic and Research Center of Fundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain.
authors.forename: Montserrat
authors.initials: M
authors.lastname: Alegret
authors.affiliation: Memory Clinic and Research Center of Fundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain.
authors.forename: Asunción
authors.initials: A
authors.lastname: Lafuente
authors.affiliation: Memory Clinic and Research Center of Fundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain.
authors.forename: Lluís
authors.initials: L
authors.lastname: Tárraga
authors.affiliation: Clinical Trials Department, Instituto Grifols S.A., Barcelona, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Núñez
authors.affiliation: Clinical Trials Department, Instituto Grifols S.A., Barcelona, Spain.
authors.forename: Mireia
authors.initials: M
authors.lastname: Torres
authors.affiliation: Banc de Sang i Teixits, Barcelona, Spain.
authors.forename: Joan Ramon
authors.initials: JR
authors.lastname: Grifols
authors.affiliation: Institut de Neuropatologia, Hospital Universitario Bellvitge, Barcelona, Spain.
authors.forename: Isidre
authors.initials: I
authors.lastname: Ferrer
authors.affiliation: Departments of Neurology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, USA.
authors.forename: Oscar L
authors.initials: OL
authors.lastname: Lopez
authors.affiliation: Clinical Trials Department, Instituto Grifols S.A., Barcelona, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Páez
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000627:therapeutic use*; D000544:Alzheimer Disease / Q000150:complications / Q000000981:diagnostic imaging; D016229:Amyloid beta-Peptides / Q000097:blood* / Q000134:cerebrospinal fluid*; D003072:Cognition Disorders / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010951:Plasma Exchange / Q000379:methods*; D011569:Psychiatric Status Rating Scales; D015898:Tomography Scanners, X-Ray Computed
chemical_list: D000418:Albumins; D016229:Amyloid beta-Peptides
keywords: Albumin; Alzheimer’s disease; CSF Aβ; plasma Aβ; plasma exchange