Conditions: Alzheimer´s Disease
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
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 sponsor.

Detailed description:

Arms:
arm 1: IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months. arm 2: IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months

Interventions: intervention 1: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Intervention descriptions: intervention 1: None

Protocol document: