Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease active immunization
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief summary:
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Detailed description:

Arms:
arm 1: arm 1: ACC-001 (Vanutide Cridificar)+ QS-21 arm 2: arm 2: ACC-001 arm 3: arm 3: QS-21 arm 4: Drug: Phosphate Buffered Saline (PBS)

Interventions: intervention 1: ACC-001 + QS-21 intervention 2: ACC-001 intervention 3: QS-21 intervention 4: Placebo: Phosphate buffered saline
Intervention descriptions: intervention 1: Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12 intervention 2: Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12 intervention 3: QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12 intervention 4: Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12

Protocol document: