Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid
Information source: Grifols Biologicals Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Albutein 5% (Biological)
Phase: Phase 2
Status: Recruiting
Sponsored by: Instituto Grifols, S.A. Official(s) and/or principal investigator(s):
Merce Boada, MD, Principal Investigator, Affiliation: Fundació ACE - Institut Català de Neurociències Aplicades, Barcelona Spain - mboada@fundacioace.com
Overall contact:
Paul Pinciaro, PhD, Phone: 410-814-7617, Email: Paul.Pinciaro@grifols.com
Summary
The purpose of this study is 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.
Clinical Details
Official title: A Phase II Study to Evaluate the Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid, and Its Effects in Patients With Mild-Moderate Alzheimer's Disease
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To determine whether plasma exchange with 5% human albumin is able to modify the concentration of beta-amyloid peptide in cerebrospinal fluid (CSF) in the treatment group of patients with Alzheimer's disease (AD).
Secondary outcome: To assess the variations in other parameters (tau protein, beta-secretase, gamma-secretase, nicastrin, etc.). - To determine whether plasma exchange with 5% human albumin is able to modify the plasma concentration of beta-amyloid.
Detailed description:
A phase II study comprised of 42 subjects (21 per group) with probable mild to moderate AD
will be conducted primarily to determine whether plasma exchange with 5% human albumin is
able to modify the concentration of beta-amyloid peptide in cerebrospinal fluid (CSF) in the
treatment group of patients with AD.
- There will be two weeks for screening and randomization of both groups (treatment and
control).
- The subjects will be randomized in a 1: 1 proportion.
- After screening and randomization, treatment will proceed as follows:
- three weeks of intensive treatment with two plasma exchanges per week
- followed by a month and a half of maintenance treatment with one weekly plasma
exchange, and
- finally, three months of treatment with one plasma exchange every two weeks.
- The control group will follow the same program, except for the plasma exchanges.
- After the treatment period ends, subjects will be followed-up for a 6-month period of
time.
The trial comprises a global multicenter (Spain and US), blind, randomized, controlled
design. The trials key coordination is based in Spain where Dr. Boada (see Study
Officials/Investigators) is the main study official. A total of 42 subjects are to be
enrolled in the study with just 10 subjects in the US.
Eligibility
Minimum age: 55 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A diagnosis of AD (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.
Exclusion Criteria:
- Any contraindication for plasma exchange due to behavioral disorders or abnormal
coagulation parameters
- Heart diseases, including antecedents of coronary disease and heart failure.
Difficult venous access precluding plasma exchange.
- 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.
- 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.
Locations and Contacts
Paul Pinciaro, PhD, Phone: 410-814-7617, Email: Paul.Pinciaro@grifols.com
Howard University Hospital/College of Medicine, Washington, District of Columbia 20060, United States; Recruiting
Oludolapo Ogunlana, B. Pharm, Phone: 202-865-1973, Email: oludolapo50@yahoo.com
Thomas O. Obisesan, MD, MPH, Principal Investigator
Mid-Atlantic Geriatric, Manchester, New Jersey 08759, United States; Recruiting
Juanita Smith, BSN, MPA, RNC, Phone: 732-657-6100, Email: research@njarc.com
Joshua Shua-Haim, MD, Principal Investigator
Additional Information
Starting date: April 2009
Last updated: April 26, 2010
|
