The purpose of this study is to provide evidence of efficacy and safety to support the development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
508
Intravenous infusion every 2 weeks over 18 months
Intravenous infusion every 2 weeks over 18 months
Change From Baseline to Month 18 in 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 each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.
Time frame: Baseline to 9 Months (actual time frame)
Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory
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: Baseline to 9 Months (actual time frame)
ADCS-Clinical Global Impression of Change (CGIC) at 18 Months
The ADCS-CGIC is a validated categorical measure of change in a participant's global clinical status between baseline and follow-up visits, based on interview of the participant and the caregiver by a skilled and experienced clinician who was blinded to treatment assignment. The ADCS-CGIC score is based on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).
Time frame: Baseline to 9 Months (actual time frame)
Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)
The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 10 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.
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Unnamed facility
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Long Beach, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Boca Raton, Florida, United States
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Delray Beach, Florida, United States
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Edgewater, Florida, United States
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Orlando, Florida, United States
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Decatur, Georgia, United States
...and 59 more locations
Time frame: Baseline to 9 Months (actual time frame)
Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement
Time frame: Baseline to 9 Months (actual time frame)
Change From Baseline to Month 18 in 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, with lower scores associated with a lower quality of life.
Time frame: Baseline to 9 Months (actual time frame)
Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)
The IADCQ is a 12-item validated questionnaire that has been developed to measure the emotional, physical, and social impact of care giving on AD caregivers. Higher scores on the IADCQ are associated with a higher impact. IADCQ total score range: 0 (no impact) - 48 (greatest impact). Each item can be scored either 0 (Not at all), 1 (A little), 2 (Somewhat), 3 (A lot), or 4 (Extremely). As this is a 12-item scale, the minimum possible score is 0 and the maximum possible score is 4x12 = 48.
Time frame: Baseline to 9 Months (actual time frame)
Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Time frame: Throughout the study period: 18 Months
Number of Participants Experiencing Any AEs and/or SAEs
Time frame: Throughout the study period: 18 Months
Number of Infusions Temporally Associated With AEs and/or SAEs
A temporal association was defined as an AE and/or SAE occurring during or within 72 hours of completion of an infusion, regardless of causality.
Time frame: During or within 72 hours of completion of an infusion
Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion
Time frame: During or within 7 days of completion of an infusion
Number of Infusions Causally Associated With AEs and/or SAEs
Time frame: Throughout the study period: 18 Months
Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE
Time frame: Throughout infusions, approximately 2-5 hours