Table 1 Selected recent/ongoing and completed LBD clinical trials 2016–2020
From: Challenges and opportunities for improving the landscape for Lewy body dementia clinical trials
ClinicalTrials.gov identifier | Population | Drug/intervention | Mechanism | Trial design | Primary outcome | Results for primary outcome |
|---|---|---|---|---|---|---|
NCT03305809 | DLB or PDD | Mevidalen | D1 positive allosteric modulator (D1PAM) | Phase 2, DB-PC | CDR computerized cognition battery continuity of attention composite score | Ongoing |
NCT03413384 | PDD | Ceftriaxone | Glutamatergic activity, excitotoxicity reduction | Phase 2, DB-PC | ADAS-Cog | Ongoing |
NCT02914366 | PDD | Ambroxol | Raise beta-Gcase, lower α-synuclein | Phase 2, DB-PC | ADAS-Cog, ADCS-CGIC | Ongoing |
NCT03774459 | PDD | Anavex2-73 | Cellular homeostasis restoration via sigma-1 and muscarinic receptors | Phase 2, DB-PC | CDR computerized cognition battery continuity of attention composite score, safety | Ongoing |
NCT03713957 | PDD or PD-MCI | GRF6021 | Plasma-derived product | Phase 2, DB-PC | Safety | Ongoing |
NCT03467152 | DLB | E2027 | Selective phosphodiesterase inhibitor type 9 | Phase 2, DB-PC | MoCA, CIBIC+ | Ongoing |
NCT04002674 | DLB | Nilotinib | Tyrosine kinase inhibitor | Phase 2, DB-PC | Safety, tolerability | Ongoing |
NCT02669433 | DLB | Intepiridine | 5HT-6 antagonist | Phase 2, DB-PC | UPDRS Part 3 | Negative |
NCT01023672 | DLB | Armodafinil | Unknown | Open-label, pilot | ESS, MWT | Positive |
NCT01340001 | DLB | DBS of nucleus basalis of Meynert | Neuromodulation | Open-label, pilot | Free recall on FCSRT | Completed no results yet |
NCT02258152 | PDD | SYN120 | 5HT-6/5HT-2A antagonist | Phase 2, DB-PC | CDR computerized cognition battery continuity of attention | Negative |
NCT01701544 | PDD | DBS of nucleus basalis of Meynert | Neuromodulation | Open-label, pilot | Abbreviated cognitive battery, safety | Safe but no cognitive improvement |
NCT02640729 | DLB or PDD with VH | Nelotanserin | 5HT-2A antagonist | Phase 2, DB-PC, cross-over | Safety, UPDRS Part 3 | Safe/well tolerated but no significant changes on endpoints |
NCT03325556 | DLB or PDD with psychosis | Pimavanserin | 5HT-2A inverse agonist/antagonist | Phase 3, time to event | Time to relapse | Positive |
NCT02708186 | DLB or PDD with RBD | Nelotanserin | 5HT-2A antagonist | Phase 2, DB-PC | RBD frequency | Negative |