At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 347 enrolled
Drug / intervention
Albumin 5% +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis With Infusion of Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Albumin 5%, Albumin 20%, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 347 participants across 40 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesSpain, United States
CollaboratorsGrifols Biologicals, LLC
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartApr 2012
Primary CompletionMar 2018
TodayJul 2026
First PostedMar 22, 2012
Enrollment StartApr 19, 2012
Primary CompletionMar 6, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 14.3 years ago
Interventions
Albumin 5%biological
Therapeutic plasma exchange with human albumin 5%
Albumin 20%biological
Low volume plasma exchange with human albumin 5%
Immunoglobulinbiological
Intravenous human immunoglobulin 5%