ESTUDIO PILOTO PARA EVALUAR LA EFICACIA Y SEGURIDAD DEL RECAMBIO PLASMÁTICO CON ALBÚMINA HUMANA 5% EN EL ACLARAMIENTO PERIFÉRICO DEL PEPTIDO BETA-AMILOIDE, Y SUS EFECTOS EN PACIENTES CON ENFERMEDAD DE ALZHEIMER LEVE-MODERADA

• Conditions: Alzheimer's disease

• Registration Number: EUCTR2005-001616-45-ES
• Lead Sponsor: Instituto Grifols S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-23
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age: 55-85 years
2. Mild-moderate Alzheimer's disease (MMSE: 20-24 according to NINCDS_ADRDA criteria)
3. Treatment with donepezil 10 mg during the last 6 months
4. Cerebrovascular disease ruled out by MRI/CT within the last 12 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Plasma beta-amyloid level below detection limit of the technique
2. Contraindications for plasma exchange, abnormal coagulation parameters or behavior disorders
3. Creatinin > 2 mg/dl
4. Non-controlled arterial hypertension
5. Hepatic cirrhosis or hepatic disorder with ALT >= 2.5 UNL or bilirubin > 2 mg/dl
6. Heart disease including coronary disease or heart failure
7. Pregnat/breast feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether plasma exchange with human albumin 5% is able to decrease plasma beta-amyloid concentration and, eventually, to cause its mobilisation from cerebrospinal fluid to plasma, as a eficacy parameter in Alzheimer's disease patients.;Secondary Objective: To assess other parameters variation, clinical improvement and safety.;Primary end point(s): Variation of plasma beta-amyloid level before and after each plasma exchange and variation during 24 weeks of follow-up.