Phase 2
N=42
Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00742417 ↗Enrolled (actual)
42
Serious AEs
12.8%
Results posted
Jun 2016
Primary outcome: Primary: Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels. — 75.3; -45.5; -86.2; -283.0 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Albutein 5% (Biological); Control (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Instituto Grifols, S.A.
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels. |
75.3; -45.5; -86.2; -283.0 | — |
| SECONDARY P-Tau and Tau CSF Levels Throughout the Study. |
87.7; 79.0; 87.5; 94.1; 78.9; 78.0 | — |
| SECONDARY Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company). |
121.3; 126.7; 120.3; 105.8; 255.7; 123.9 | — |
| SECONDARY Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company). |
2.8; 33.7; 6.6; 20.9; 9.8; 4.9 | — |
| SECONDARY Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest). |
40.1; 49.5; 20.4; 33.4; 29.1; 45.4 | — |
| SECONDARY Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD) |
-1.7; -3.8; 3.9; 6.6; 1.3; -0.5 | — |
| SECONDARY Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC). |
-7.1; -4.9; -1.7; -4.0; -2.1; -3.6 | — |
| SECONDARY Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline. |
1.90; 1.91; 1.76; 1.85; 1.64; 1.76 | — |
| SECONDARY Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT) |
25; 20; 25; 10; 5; 5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00742417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.