Combined treatement with human albumin and intravenous immunoglobulin in Alzheimer disease

Phase 1

• Conditions: MedDRA version: 14.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Mild to Moderate Alzheimer's Disease patients.

• Registration Number: EUCTR2011-001598-25-ES
• Lead Sponsor: INSTITUTO GRIFOLS, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1.Males or females between 55-85 years of age at the time of signing of the informed consent document.
2.A diagnosis of AD (NINCDS-ADRDA criterion), and Mini-mental Status Examination (MMSE) score between =18 and =26.
3.Current stable treatment with acetylcholine esterase inhibitors (AChEIs) for the previous three months.
4.The patient and a close relative or legal representative must read the patient information sheet, agree to participation in the trial, and then sign the informed consent document (the patient personally and the close relative/legal representative).
5.The patient must be able to follow the study protocol, receive the treatment in the established time period, and continue during the follow-up interval.
6.A brain Computed Axial Tomography (CAT) or Magnetic Resonance Imaging (MRI) study, obtained in the 12 months prior to recruitment, showing the absence of cerebrovascular disease, must be available.
7.A stable care taker must be available, and must attend the patient study visits.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1.Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:
•Hypocalcemia (Ca++ < 8.7 mg/dL).
•Thrombocytopenia (<100,000/?L).
•Fibrinogen <1.5 g/L.
•Prothrombin time (Quick) p<60% versus control.
•Beta-blocker treatment and bradycardia <60/min.
•Treatment with angiotensin-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions).
2.Hemoglobin < 10 g/dL
3.Difficult venous access precluding plasma exchange.
4.A history of frequent adverse reactions (serious or otherwise) to blood products.
5.Hypersensitivity to albumin or allergies to any of the components of Albutein®.
6.History of immunoglobulin A (IgA) deficiency.
7.Known allergies to Flebogamma® DIF components such as sorbitol.
8.History of thromboembolic complications of intravenous immunoglobulins.
9.Plasma creatinine > 2 mg/dL.
10.Uncontrolled high blood pressure.
11.Liver cirrhosis or any liver problem with alanine aminotransferase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
12.Heart diseases, including antecedents of coronary disease and heart failure.
13.Participation in other clinical trials, or the reception of any other investigational drug in the three months prior to the start of the study.
14.Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, toxic habits, etc.).
15.Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
16.Fewer than six years of education.
17.Prior behavioral disorders requiring pharmacological treatment, including insomnia

Study & Design

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