Table 1.
Selected recent/ongoing and completed LBD clinical trials 2016–2020
| 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 |
Abbreviations: ADAS-Cog Alzheimer’s Disease Assessment Scale-Cognitive Subscale, ADCS-CGIC AD Cooperative Study-Clinical Global Impression of Change, CIBIC+ Clinician’s Interview-Based Impression of Change plus Caregiver Input, DB-PC double-blind, placebo controlled, DLB dementia with Lewy bodies, ESS Epworth Sleepiness Scale, FCSRT Free and Cued Selective Reminding Test, LBD Lewy body dementia, MoCA Montreal Cognitive Assessment, MWT Maintenance of Wakefulness Test, PDD Parkinson’s disease dementia, RBD REM sleep behavior disorder, UPDRS Unified Parkinson’s Disease Rating Scale, VH visual hallucinations