IGIV in the treatment of Alzheimer's disease: Phase III clinical trial in Philadelphia

July 5, 6:55 PMPhiladelphia Alzheimer’s Disease ExaminerLynda Seminara

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For more than two decades, immune globulin administered intravenously (IGIV) has been successful in treating various autoimmune diseases.

Mounting evidence shows that immunotherapy targeting the amyloid beta peptide can be used to treat Alzheimer's disease. Because IGIV contains anti-amyloid antibodies, it may prove successful in the treatment of Alzheimer’s disease.

Two previous studies demonstrated that IGIV confers significant cognitive improvement while reducing amyloid levels in the brain. IGIV contains antibodies that bind to oligomeric and fibrillar beta amyloid.

Phase III Study: Currently Enrolling Volunteers

The present Phase III study will determine whether IGIV (10% treatment) results in a significantly slower rate of decline of dementia symptoms in people with mild to moderate Alzheimer’s disease. Subjects will be assigned randomly to receive intravenous infusions of either of two doses of IGIV, 10% or placebo every two weeks for 70 weeks (36 infusions) as an add-on to conventional FDA-approved medications for Alzheimer's disease.

This study is being conducted throughout the United States, including the following local site:

Local Study Site

UNIVERSITY OF PENNSYLVANIA
Philadelphia, PA 19104

Contact: Steven Arnold, MD
Tel: 215-573-2840
Email: sarnold@mail.med.upenn.edu

Contact: Deb Rooney
Tel: 215 662-7057
Email: derooney@mail.med.upenn.edu
 

 Eligibility Criteria

• Men and women, ages 50 to 89 years
• Diagnosis of probable Alzheimer's disease: dementia of mild to moderate severity (MMSE between 16 and 26) at the time of screening
• Available caregiver who is willing and able to participate in the study for its full duration
• Neuroimaging (CT or MRI) performed after symptom onset consistent with the diagnosis of Alzheimer's disease
• Ability to comply with testing and infusion regimens, including fluency in English or Spanish, adequate corrected visual acuity, and hearing ability
• Be on stable doses of FDA-approved medication(s) for Alzheimer's disease for at least 3 months before screening; these medications must be continued throughout the study

Additional Information

Each subject will be tested at the study site and will be treated intravenously every 2 weeks for 70 weeks (about 18 months). The first three infusions must be done at the site. If the infusions are well tolerated, subsequent administrations may be done by a qualified healthcare provider at home or another suitable location. Participants must return to the site every 3 months for cognitive assessments, blood tests, and brain imaging.