CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Albutein 5% +1 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.

Search/NCT00742417
NCT00742417Phase 2Completed

Phase II Study to Evaluate the Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid, and Its Effects in Patients With Mild-moderate Alzheimer's Disease.

Instituto Grifols, S.A.·interventional·Posted Aug 27, 2008·Updated Jun 14, 2016

In Brief

A Phase 2 clinical trial evaluating Albutein 5% and Control for Alzheimer's Disease. Completed, enrolled 42 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain, United States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2008
Enrollment StartJul 1, 2007
Primary CompletionFeb 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.8 years ago

Interventions

Albutein 5%biological

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

Controlother

Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)