Status:
COMPLETED
A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease
Lead Sponsor:
Baxalta now part of Shire
Collaborating Sponsors:
Alzheimer's Disease Cooperative Study (ADCS)
Conditions:
Alzheimer´s Disease
Eligibility:
All Genders
50-89 years
Phase:
PHASE3
Brief 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...
Detailed Description
Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2012
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00818662
Start Date
December 19 2008
End Date
December 10 2012
Last Update
May 19 2021
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Sun City, Arizona, United States
4
Tucson, Arizona, United States