You are viewing an inactive listing
This listing is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active listings please search here

Rochester, New York

  • Alzheimer´s Disease

Purpose:

The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.


Criteria:

Main Inclusion Criteria: - Completed 18 months of study treatment and assessments in Baxter precursor study 160701 - Diagnosis of probable Alzheimer´s Disease (AD) - Able to comply with testing and infusion regimen (including adequate corrected visual acuity and hearing ability) - Has a caregiver (study partner) who is willing and able to participate Main Exclusion Criteria: - Significant neurological disease other than AD - Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent heart attack) - Contraindication to undergoing MRI (e.g. pacemaker [with the exception of an MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a metal plate) - Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, or multiple lacunae) - Active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment - Uncontrolled major depression, psychosis, or other major psychiatric disorder(s) - Poorly controlled diabetes - Serious problems with liver or kidneys - Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin) - Current or recent treatment with immunomodulatory therapies (with the exception of immunoglobulin and non-systemic and low-dose systemic corticosteroids) - Recent use of investigational drugs or biologics, including those aimed at altering AD progression (with the exception of immunoglobulin) - Active immunization for the treatment of AD at any time There are reasons why it might not be appropriate to participate in this trial. Please contact Medical Information at medinfo@baxter.com for details.


NCT ID:

NCT01736579


Primary Contact:

Study Director
Study Director
Takeda


Backup Contact:

N/A


Location Contact:

Rochester, New York
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 19, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.