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:
Baxter Healthcare Corporation
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Drug Information available for:
Rho(D) Immune Globulin
U.S. FDA Resources
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 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 June 18, 2013