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

Phase 3TerminatedNCT01736579

Baxalta now part of Shire6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer´s Disease

Interventions

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

Eligibility

Sex: ALLMin age: 51 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Rochester, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

Secondary Outcomes

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

The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at the site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment.

Time frame: 6 months

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

The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.

Time frame: 6 months

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

Data from ClinicalTrials.gov

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