Clinical trial NCT01736579: Long-Term Study of IGIV, 10% in Alzheimer´s Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer´s Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 6
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 6 months
measure: Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 6 months
measure: Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 6 months
measure: Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
timeFrame: 6 months
Secondary outcomes:
measure: Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)
timeFrame: 6 months
measure: Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)
timeFrame: 6 months
measure: Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
timeFrame: 6 months
measure: Mini Mental State Examination (MMSE)
timeFrame: 6 months
measure: Neuropsychiatric Inventory (NPI) Score
timeFrame: 6 months
measure: Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
timeFrame: 6 months
measure: EQ-5D Questionnaire (Proxy Version)
timeFrame: 6 months
measure: Healthcare Resource Utilization Questionnaire (HRUQ)
timeFrame: 6 months
measure: Caregiver Burden Questionnaire
timeFrame: 6 months
measure: Time to Skilled Nursing Facility Placement
timeFrame: 6 months
measure: Volumetric MRI
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
state: New York
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: