Status:
Completed
Clinicaltrials.gov identifier:
Sponsor:
Eli Lilly and Company
Enrollment:
344
Study Design:
This is a phase 2, randomized, parallel assigned, double-blinded, interventional study assessing the safety and efficacy of the study drug, LY3154207, in participants with Lewy body dementia. Participants between the ages of 40 and 85 years with a clinical diagnosis of PD or dementia with Lewy bodies deemed to have increased functional impairment due to a decline in cognitive functions are eligible for inclusion. The MoCA score must be between 10-23. Certain medication classes are allowed if the participants have been on a stable dose for 3 weeks before the screening and expected to remain on a stable dose throughout the study. The medications allowed include antihypertensives, antiparkinson, antidepressants, medications for cognition and psychosis [clozapine, quetiapine, and pimavanserin]. Participants on antipsychotics other than listed above and anticholinergics will be excluded. Participants are required to have reliable caregivers. Standard exclusionary criteria apply. Participants will be randomly assigned to one of the four arms: 1. Experimental arm 1: high dose of the investigational drug orally; 2. Experimental arm 2: mid dose of the investigational drug orally; 3. Experimental arm 3: low dose of the investigational drug orally; and 4. Placebo arm.
Rationale:
The primary outcome measure will assess the change at 12 weeks from baseline in the continuity of attention composite score of the cognitive drug research computerized cognition battery (CDR-CCB). The secondary outcome measures assess the change in various scales at 12 weeks from baseline. The scales included mostly assess the cognitive and psychiatric domains. Additional measures assess the change in the MDS-UPDRS total score, vital signs, and even the pharmacokinetics.
Comments:
D1R is a potentially interesting target for the management of both PD motor and non-motor disability. While there are other D1R agonists being explored for motor benefits, LY3154207 focuses on cognition. The phase 2 has completed enrolment and is awaiting results.
