Back to resultsLong-Term Study of IGIV, 10% in Alzheimer´s Disease
Primary Purpose
Alzheimer´s Disease
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer´s Disease
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IGIV, 10% at 0.2 g/kg body weight
IGIV, 10% at 0.4 g/kg body weight
Arm Description
IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.
IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months
Outcomes
Primary Outcome Measures
Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
Secondary Outcome Measures
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.
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.
Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.
Mini Mental State Examination (MMSE)
The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.
Neuropsychiatric Inventory (NPI) Score
The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.
Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.
EQ-5D Questionnaire (Proxy Version)
EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day.
Healthcare Resource Utilization Questionnaire (HRUQ)
The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.
Caregiver Burden Questionnaire
The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.
Time to Skilled Nursing Facility Placement
Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.
Volumetric MRI
Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.
Full Information
NCT ID
NCT01736579
First Posted
November 27, 2012
Last Updated
April 30, 2021
Sponsor
Baxalta now part of Shire
1. Study Identification
Unique Protocol Identification Number
NCT01736579
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.
Study Start Date
November 29, 2012 (Actual)
Primary Completion Date
June 4, 2013 (Actual)
Study Completion Date
June 4, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer´s Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IGIV, 10% at 0.2 g/kg body weight
Arm Type
Experimental
Arm Description
IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.
Arm Title
IGIV, 10% at 0.4 g/kg body weight
Arm Type
Experimental
Arm Description
IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months
Intervention Type
Drug
Intervention Name(s)
Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Other Intervention Name(s)
Gammagard Liquid
Primary Outcome Measure Information:
Title
Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
6 months
Title
Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
6 months
Title
Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
6 months
Title
Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)
Description
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
Title
Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)
Description
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
Title
Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
Description
The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.
Time Frame
6 months
Title
Mini Mental State Examination (MMSE)
Description
The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.
Time Frame
6 months
Title
Neuropsychiatric Inventory (NPI) Score
Description
The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.
Time Frame
6 months
Title
Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
Description
The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.
Time Frame
6 months
Title
EQ-5D Questionnaire (Proxy Version)
Description
EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day.
Time Frame
6 months
Title
Healthcare Resource Utilization Questionnaire (HRUQ)
Description
The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.
Time Frame
6 months
Title
Caregiver Burden Questionnaire
Description
The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.
Time Frame
6 months
Title
Time to Skilled Nursing Facility Placement
Description
Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.
Time Frame
6 months
Title
Volumetric MRI
Description
Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Rochester
State/Province
New York
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-Term Study of IGIV, 10% in Alzheimer´s Disease
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