At a glance
ClinicalIndex Comparison Record- ✓Probable Alzheimer's Disease diagnosis
- ✓MMSE score 16-26 (21-26 in Germany)
- ✓Brain MRI consistent with Alzheimer Disease
- ✓Concurrent cholinesterase inhibitor or memantine allowed if stable
- ✕Significant neurological disease other than Alzheimer's disease
- ✕Major psychiatric disorder
- ✕Contraindication to undergo brain MRI
- ✕Clinically significant systemic illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease
In Brief
A Phase 2 clinical trial evaluating ACC-001 + QS-21, ACC-001, and 2 other interventions for Alzheimer Disease. Completed, enrolled 86 participants across 24 sites in 3 countries.
Detailed Summary
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Study Details
Timeline
Interventions
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12