Phase 3
Completed N=347
A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease
Source: ClinicalTrials.gov NCT01561053 ↗Enrolled (actual)
347
Serious AEs
15.8%
Results posted
Jul 2019
Primary outcomePrimary: Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months) — 0.8; 0.8; 1.5; 3.2 units on a scale
◆ Published Evidence
Emerging
13citations · ~3 / year
Neuroimaging analyses from a randomized, controlled study to evaluate plasma exchange with albumin replacement in mild-to-moderate Alzheimer's disease: additional results from the AMBAR study.
Summary
The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.
Linked Publications (2)
-
Neuroimaging analyses from a randomized, controlled study to evaluate plasma exchange with albumin replacement in mild-to-moderate Alzheimer's disease: additional results from the AMBAR study.
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Application of a Novel Endpoint Staging Framework: Proof of Concept in the AMBAR Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months) |
0.8; 0.8; 1.5; 3.2; 1.0 | — |
| PRIMARY Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score (Changes From Baseline to 14 Months) |
-3.5; -2.0; -3.9; -6.7; -3.2 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Males or females between 55-85 years of age at the time of signing of the informed consent document.
- A diagnosis of Alzheimer's disease (NINCDS-ADRDA criterion), and mini-mental status examination (MMSE) score between >/=18 and 1.5)
- Beta-blocker treatment and bradycardia 2 mg/dl.
- Uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood pressure of 100 mmHg or higher despite treatment during the last 3 months).
- Liver cirrhosis or any liver problem with glutamic pyruvic transaminase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
- Heart diseases, as evidenced by myocardial infarction, severe or unstable angina, or heart failure (New York Association Class II, III or IV) in the past 12 months.
- Participation in other clinical trials, or the receipt 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, known drug or alcohol abuse, 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 (exclusion criteria under medical criterion).
- Less than three months with stable treatment for behavioral disorders or insomnia.
- Patients being treated with anticoagulants or antiplatelet therapy (antiaggregants) should not be recruited in the study.
Data sourced from ClinicalTrials.gov (NCT01561053) and the linked publication. 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. Informational only — not medical advice.