Trial record 3 of 3 for:    Alzheimer's | baxter [Lead]

Long-Term Study of IGIV, 10% in Alzheimer´s Disease

This study has been terminated.
(The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.)
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01736579
First received: November 27, 2012
Last updated: May 19, 2013
Last verified: May 2013
  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.


Condition Intervention Phase
Alzheimer´s Disease
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Long-Term Safety and Efficacy of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) in Mild to Moderate Alzheimer´s Disease

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Incidence and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 3 years, 6 months ] [ Designated as safety issue: Yes ]
  • Number of infusions discontinued, slowed, or interrupted due to an AE/SAE [ Time Frame: Up to 3 years, 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cognition and activities of daily living [ Time Frame: Up to 3 years, 6 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2012
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGIV, 10% at 0.2 g/kg body weight
IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Other Name: Gammagard Liquid
Experimental: IGIV, 10% at 0.4 g/kg body weight
IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Other Name: Gammagard Liquid

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736579

Locations
United States, New York
Rochester, New York, United States
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Kathy Tobias, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01736579     History of Changes
Other Study ID Numbers: 161202
Study First Received: November 27, 2012
Last Updated: May 19, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014