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

NCT01736579 | Terminated Phase 3 Results DMC

• 1 other identifier: 161202
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer´s Disease

Outcome Measures

Primary Outcomes (4)

• Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  6 months

• Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  6 months

• Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  6 months

• Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)

  6 months

Secondary Outcomes (11)

• Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)

  6 months

• Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)

  6 months

• Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)

  6 months

• Mini Mental State Examination (MMSE)

  6 months

• Neuropsychiatric Inventory (NPI) Score

  6 months

Study Arms (2)

IGIV, 10% at 0.2 g/kg body weight

EXPERIMENTAL

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%)

IGIV, 10% at 0.4 g/kg body weight

EXPERIMENTAL

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%)

Interventions

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) DRUG

Also known as: Gammagard Liquid

IGIV, 10% at 0.2 g/kg body weight; IGIV, 10% at 0.4 g/kg body weight

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (1)

Unknown Facility

Rochester, New York, United States

Location

MeSH Terms

Interventions

gamma-Globulins

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This study was an extension of study 160701 and was stopped early due to lack of evidence of clinical benefit of IGIV treatment in Alzheimer's Disease patients in Baxalta study 160701. Summary tables available for safety data only.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: November 29, 2012
• Primary Completion: June 4, 2013
• Study Completion: June 4, 2013
• Last Updated: May 19, 2021
• Results First Posted: August 23, 2016

Record last verified: 2021-04

Locations

US (1)