Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Amyloidosis
Intervention: Albutein 5%; Control
Intervention description: 18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks; Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's; Dementia; Senile; Loss of cognitive abilities; Old age; Elderly; Aging; Albumin; Caregiver; amyloid; beta amyloid; Central Nervous System Diseases; Brain Disease; Mental Disorders; Plasma Exchange

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.