Table 1.
Active and passive trials for immunotherapeutical approaches to treat AD (www.clinicaltrials.gov)
| ACTIVE | ||||
|---|---|---|---|---|
| Pharmaceutical Company | Trial | Stage | Status | |
| Aβ Target | ||||
| ELAN | AN1792 | Phase II | (2000–2002) halted, no improvement, encephalitis 6% | Aggregated Aβ1-42, QS21, Polysorbate80 |
| Novartis | CAD106 | Phase I Phase II |
Aβ titers, no change biomarkers Not reported |
Aβ1-6/Bacteriophage Qβ |
| Janssen/Pfizer | ACC-001 | Phase II | Not reported, finishing | Aβ1-6-QS21 |
| Affinis AG/GSK | AFFITOME AD02 | Phase II | Not reported | Mimotope of unmodified Aβ N-terminus |
| Affinis AG | AFFITOME | Phase I | Ongoing | Mimotope of pyroglutamic-3 modified Aβ N-terminus |
| AC Immune | ACI-24 | Phase I/IIa | Not reported | β-sheet conformation of Aβ peptide |
| Tau Target | ||||
| Axon | AAD vac1 | Phase I | Ongoing continuation, tolerable, safe, antibody titers | Synthetic mutant tau peptide coupled to KLH-ALUM |
| PASSIVE | ||||
| Monoclonal antibody/target | ||||
| Janssen/Pfizer | Bapineuzumab AAB-001 |
Phase II Phase III |
No clinical improvement, ARIA, trend to efficacy No improvement, halted |
Humanized 3D6, anti-Aβ1-5, six infusions, different dosages |
| Eli Lilly | Solaneuzumab | Phase III(2) | No improvement overall, secondary analysis slight improvement in early AD; ongoing extension in early AD | Humanized mAb266 Anti-Aβ16-24 |
| Janssen/Pfizer | Bapineuzumab AAB-003 |
Phase I | Ongoing | Hu IgG4 3D6 to reduce ARIA |
| Hoffman-La Roche | Gantenerumab DIAN |
Phase III | Ongoing, future: in autosomal dominant AD | Antibody to fibrillar form of Aβ Positions 3–12; 18–27 |
| Eli Lilly | Solaneuzumab A4 |
Phase III | Starting: asymptomatic AD with positive PET | Humanized mAb266 Anti-Aβ16-24 |
| AC Immune/Genentech | Crenezumab ABBY BLAZE API |
Phase II/III Phase II Phase II Phase III |
Failed to meet clinical co-primary endpoints No difference in biomarkers/FDG-PET Ongoing in EOAD families with PS1 mut. E280A |
Hu IgG4 anti-multiple epitopes Aβ1-40 |
| Octapharma | IVIG Octapharma | Phase II | Safe, no improvement | Three different doses of naturally occurring anti-Aβ |
| Baxter | IVIG Gammagrad | Phase III | No improvement, data not released | Naturally occurring anti-Aβ |
| Baxter | IVIG newGAM | Phase II | Ongoing | Naturally occurring anti-Aβ |