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J Alzheimers Dis. 2017;56(1):129-143. doi: 10.3233/JAD-160565.

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.

Author information

1
Memory Clinic and Research Center of Fundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain.
2
Neurology Service, Hospital General Universitari Vall d'Hebron, Barcelona, Spain.
3
Nephrology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
4
Banc de Sang i Teixits, Barcelona, Spain.
5
Neurology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
6
Alzheimer's Research Corporation, Mid Atlantic Geriatric Association, Manchester, NJ, USA.
7
Department of Internal Medicine, Howard University, Washington, DC, USA.
8
Clinical Trials Department, Instituto Grifols S.A., Barcelona, Spain.
9
Institut de Neuropatologia, Hospital Universitario Bellvitge, Barcelona, Spain.
10
Departments of Neurology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, USA.

Abstract

BACKGROUND:

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.

OBJECTIVE:

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).

METHODS:

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.

RESULTS:

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).

CONCLUSION:

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.

KEYWORDS:

Albumin; Alzheimer’s disease; CSF Aβ; plasma Aβ; plasma exchange

PMID:
27911295
PMCID:
PMC5240541
DOI:
10.3233/JAD-160565
[Indexed for MEDLINE]
Free PMC Article

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