Table 1.
Current ongoing clinical trials for Aβ immunotherapy (Clinicaltrials.gov, as of 1 October 2022).
| Agent | Immunization | Target | Phase | Study Population | Clinical Trial # | Status | Sponsor(s) |
|---|---|---|---|---|---|---|---|
| ABvac40 | Active | Aβ (33–40) | Phase II | Amnestic mild cognitive impairment or very mild AD | NCT03461276 | Active, not recruiting | Araclon Biotech S.L. |
| Aducanumab (BIIB037) | Passive | Aβ (3–7) | Phase III | Early AD | NCT04241068 | Active, not recruiting | Biogen |
| Phase IV | Early AD | NCT05310071 | Recruiting | Biogen | |||
| Phase I | Mild cognitive impairment or mild AD | NCT05469009 | Recruiting | Ali Rezai, InSightec | |||
| Gantenerumab (RO4909832) | Passive | Aβ (2–11 and 18–27) | Phase II | Early AD | NCT04592341 | Active, not recruiting | Roche |
| Phase III | Early AD | NCT03443973 | Active, not recruiting | Roche | |||
| Phase III | Early AD | NCT03444870 | Recruiting | Roche | |||
| Phase III | Early AD | NCT04339413 | Active, not recruiting | Roche | |||
| Phase III | With risk for AD or early AD | NCT05256134 | Recruiting | Roche | |||
| Phase III | Prodromal to mild AD | NCT04374253 | Recruiting | Roche | |||
| Phase III | With risk for or with early AD caused by a genetic mutation | NCT05552157 | Not yet recruiting | WUSM, Roche, AA, NIA Genentech, Inc. |
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| Donanemab (LY3002813) | Passive | Pyrogluta-mate Aβ (p3–7) | Phase I | Healthy | NCT05567159 | Not yet recruiting | Eli Lilly |
| Phase I | Healthy Chinese participants | NCT05533411 | Not yet recruiting | Eli Lilly | |||
| Phase III | Early symptomatic AD | NCT04437511 | Active, not recruiting | Eli Lilly | |||
| Phase III | Preclinical AD | NCT05026866 | Recruiting | Eli Lilly | |||
| Phase II | Symptomatic AD | NCT04640077 | Active, not recruiting | Eli Lilly | |||
| Phase III | Early symptomatic AD | NCT05508789 | Not yet recruiting | Eli Lilly | |||
| Lecanemab (BAN2401) | Passive | Aβ protofibrils (1–16) | Phase I | Healthy | NCT05533801 | Not yet recruiting | Eisai. |
| Phase III | Preclinical AD | NCT04468659 | Recruiting | Eisai. ACTC, Biogen, NIA | |||
| Phase III | Early AD | NCT03887455 | Active, not recruiting | Eisai. Biogen | |||
| Phase II | Early AD | NCT01767311 | Active, not recruiting | Eisai. Biogen | |||
| Solanezumab (LY2062430) | Passive | Aβ protofibrils (1–16) | Phase III | With risk for memory loss | NCT02008357 | Active, not recruiting | Eli Lilly, ATRI |
| RO7126209 * | Passive | Aβ fibrils | Phase I/II | Prodromal or mild to moderate AD | NCT04639050 | Recruiting | Roche |
| Crenezumab (MABT5102A) | Passive | Soluble Aβ oligomers (13–24) | Phase II | Preclinical autosomal dominant AD with PSEN1 E280A mutation | NCT01998841 | Active, not recruiting | Genentech, Inc. NIA, Banner Alzheimer’s Institute |
| SHR−1707 | Passive | Aβ | Phase I | Healthy young adult and elderly | NCT04973189 | Recruiting | Shanghai Hengrui Pharmaceutical Co. |
| LY3372993 | Passive | Pyrogluta-mated form of Aβ | Phase I | Healthy and AD | NCT04451408 | Recruiting | Eli Lilly |
| Phase III | Early AD | NCT05463731 | Recruiting | Eli Lilly | |||
| ACU193 | Passive | Soluble Aβ oligomers | Phase I | MCI or mild AD | NCT04931459 | Recruiting | Acumen Pharmaceuticals, NIA |
*: RO7126209 is a new version of gantenerumab, engineered to cross the BBB more easily using a “brain shuttle” technology. AA, Alzheimer’s Association; ACTC, Alzheimer’s Clinical Trials Consortium; ATRI: Alzheimer’s Therapeutic Research Institute; NIA: National Institute on Aging; WUSM, Washington University School of Medicine.