Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid

Completed · Phase 2

Conditions studied: Alzheimer's Disease

In brief

The purpose of this study was to evaluate the efficacy and safety of plasma exchange with 5% albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients with mild-moderate Alzheimer's disease.

Key facts

Study ID

NCT00742417

Run by

Instituto Grifols, S.A.

People needed

42

Starts

2007-07-01

Expected to finish

2011-03-01

Last updated by the study team

2016-06-14

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of AD ( National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA] criterion), and Mini-mental Status Examination (MMSE) score between ≥18 and ≤26.
• Current stable treatment with acetylcholine esterase inhibitors (AChEIs) for the previous three months.
• A stable care taker must be available, and must attend the patient study visits.
• 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).
• 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.
• 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.

You may not qualify if…

• Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters
• A history of frequent adverse reactions (serious or otherwise) to blood products.
• Hypersensitivity to albumin or allergies to any of the components of Albutein 5% Human Albumin.
• Plasma creatinine > 2 mg/dL.
• Uncontrolled high blood pressure.
• Liver cirrhosis or any liver problem with alanine aminotransferase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
• Heart diseases, including antecedents of coronary disease and heart failure.
• Difficult venous access precluding plasma exchange.
• Participation in other clinical trials, or the reception of any other investigational drug in the three months prior to the start of the study.
• Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, toxic habits, etc.).
• Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
• Fewer than six years of education.
• Prior behavioral disorders requiring pharmacological treatment, including insomnia.

Where it is running

• Howard University — Washington D.C., District of Columbia, United States
• Mid-Atlantic Geriatric/ARC — Whiting, New Jersey, United States
• Fundació ACE — Barcelona, Catalonia, Spain
• Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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