Alzheimer's disease
Conditions
Interventions
Trade Name: Albúmina Humana Grifols
Product Name: Albúmina humana al 5%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ALBUMINA HUMANA
Concentration unit: g/l gram(s)/litre
Concentrat
Sponsors
Instituto Grifols S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Outcome results
None listed