Conditions: Alzheimer's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin \[IVIG\]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild to moderate Alzheimer's disease.

Detailed description:
Participants received 12 infusions of 0.1 g/kg, 0.25 g/kg, or 0.4 g/kg body weight octagam 10% at 2-week intervals (±3 days) or 6 infusions of 0.2 g/kg, 0.5 g/kg, or 0.8 g/kg body weight octagam 10% at 4-week intervals (±5 days). The effect of the infusions on the reduction of Aβ peptide in CSF and the increase of Aβ peptide in blood plasma was evaluated.

Arms:
arm 1: Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions). arm 2: Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions). arm 3: Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). arm 4: Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). arm 5: Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions). arm 6: Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions). arm 7: Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions). arm 8: Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).

Interventions: intervention 1: Placebo intervention 2: octagam 10%
Intervention descriptions: intervention 1: Commercially available 0.9% isotonic sodium chloride solution. intervention 2: octagam 10% was supplied as ready-to-use solutions of human immunoglobulin.

Protocol document: