Long-Term Study of IGIV, 10% in Alzheimer´s Disease
Baxalta US Inc.
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
ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of
injectable products to it's optimum/right spot, just outside of the fascia, which exists
subdermally (between the skin and muscle). Bloodless basically implies longer lasting
medicinal effects, and minimal side effects - advantages that reflect the NIH mission of
enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS
device is stabilized on the surface of the skin with negative pressure and emits an
electrical current to create a bloodless cavity subdermally. ASIS device correctly,
automatically, and consistently delivers therapeutic agents, yet requiring little skill of a
practitioner - providing the steady and safe infusion into subdermal bloodless space of
virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel,
Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on
the healthcare industry."
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