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The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Globulin Intravenous (Human), 10% (IGIV, 10%) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
There are reasons why it might not be appropriate to participate in this trial. Please contact Medical Information at medinfo@baxter.com for details.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester | New York | United States |
Six participants were enrolled (i.e. signed informed consent form), of which 2 failed screening and 4 were treated with study product.
Enrollment was conducted at one clinical site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | IGIV, 10% at 0.2 g/kg Body Weight | IGIV, 10% at 0.2 g/kg body weight every 2 weeks |
| FG001 | IGIV, 10% at 0.4 g/kg Body Weight | IGIV, 10% at 0.4 g/kg body weight every 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IGIV, 10% at 0.2 g/kg Body Weight | IGIV, 10% at 0.2 g/kg body weight every 2 weeks |
| BG001 | IGIV, 10% at 0.4 g/kg Body Weight | IGIV, 10% at 0.4 g/kg body weight every 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Posted | Number | adverse events | 6 months |
|
|
Throughout the study period (6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IGIV, 10% at 0.2 g/kg Body Weight | IGIV, 10% at 0.2 g/kg body weight every 2 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion Site Pain | General disorders | MedDRA | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Posted | Number | infusions | 6 months | Infusions | Infusions |
|
|
|
| Primary | Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Posted | Number | infusions | 6 months | Infusions | Infusions |
|
|
|
| Primary | Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE) | Posted | Number | infusions | 6 months | Infusions | Infusions |
|
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| Secondary | 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. | This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality. | Posted | 6 months |
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | IGIV, 10% at 0.4 g/kg Body Weight | IGIV, 10% at 0.4 g/kg body weight every 2 weeks. | 0 | 2 | 1 | 2 |
| Tooth Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
Baxalta's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxalta requires a review of results communications (eg, for confidential information) ≥30 days prior to submission or communication. Baxalta may request an additional delay of ≤60 days eg, for intellectual property protection.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |