Phase 3
Completed N=383
A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease
Source: ClinicalTrials.gov NCT00818662 ↗Enrolled (actual)
383
Serious AEs
20.6%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) — 7.4; 8.9; 8.4 Scores on a scale — p=0.476
Summary
The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion compared with placebo in participants with mild to moderate Alzheimer's disease (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) |
7.4; 8.9; 8.4 | 0.476 |
| PRIMARY Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) |
-11.4; -12.4; -11.4 | 0.812 |
| SECONDARY Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) |
2.7; 4.5; 3.5 | 0.368 |
| SECONDARY Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) |
-5.4; -6.1; -5.8 | 0.778 |
| SECONDARY Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment |
0; 0; 0; 2; 1; 1 | 0.306 |
| SECONDARY Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment |
0; 0; 0; 1; 2; 1 | 0.660 |
| SECONDARY Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination |
-12.1; -15.3; -13.5 | 0.206 |
| SECONDARY Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment |
3.7; 4.9; 2.4 | 0.640 |
| SECONDARY Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response |
-0.5; -0.7; -1.5 | 0.093 |
| SECONDARY Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response |
-3.0; -2.5; -1.6 | 0.096 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward |
-0.8; -1.2; -1.1 | 0.167 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward |
-0.8; -1.2; -1.2 | 0.173 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency |
-4.7; -7.4; -6.3 | 0.238 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution |
-6.8; -7.7; -6.2 | 0.695 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency |
-2.8; -2.2; -2.7 | 0.988 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A |
21.6; 20.5; 21.3 | 0.783 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B |
13.0; 28.4; 31.9 | 0.191 |
| SECONDARY Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test |
-0.7; -0.7; -0.6 | 0.588 |
| SECONDARY Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class |
7; 2; 1; 1; 0; 4 | — |
| SECONDARY Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class |
13; 7; 5; 3; 11; 15 | — |
| SECONDARY Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class |
2; 0; 1; 5; 3; 3 | — |
| SECONDARY Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) |
396; 467; 349 | — |
| SECONDARY Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs) |
225; 265; 172 | — |
| SECONDARY Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE) |
48; 28; 36 | — |
| SECONDARY Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits |
31; 24; 16 | — |
| SECONDARY Number of Participants Experiencing a Clinically Significant Rash |
3; 2; 0; 19; 16; 8 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Written informed consent - participant (or participant´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study
- Diagnosis of probable Alzheimer´s Disease (AD)
- Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening
- Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis
- Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability
- On stable doses of regulatory authority approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.
- If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening
Main Exclusion Criteria (Reasons why it might not be appropriate to participate):
- Any other forms of dementia
- Medical issues that might increase the risk of treatment with IGIV, 10%, such as:
- Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
- Evidence of current bleeding in the brain by MRI
- Serious problems with the liver or kidneys
- Allergies to blood products
- Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:
- Diabetes
- Recent treatment with chemotherapy or immune suppression
- The recent use of other investigational drugs, especially antibody therapy for AD
- Severe headaches or psychiatric problems
Data sourced from ClinicalTrials.gov (NCT00818662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.