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Abstract Details

Results of the Presence Study Evaluating Mevidalen for the Treatment of Lewy Body Dementia (LBD)
Aging, Dementia, and Behavioral Neurology
Aging and Dementia Posters (7:00 AM-5:00 PM)
019
To assess the safety and efficacy of mevidalen, a D1 receptor positive allosteric modulator, for the treatment of cognition in patients with LBD.

Mevidalen is a novel D1PAM that enhances dopaminergic transmission at the D1 receptor in the presence of endogenous and exogenous dopamine. Frontal D1 receptors are important in attention, memory and executive function, and D1 activation improves cognitive and motor function and enhances wakefulness in preclinical and clinical models. Mevidalen is in clinical development as a potential symptomatic treatment for mild-to-moderate dementia associated with LBD and to explore its effects across several symptomatic domains relevant to LBD including cognition, motor function and sleep.

 
PRESENCE (NCT03305809) was a Phase 2, 12-week study in LBD participants with mild-to-moderate dementia randomized (1:1:1:1) to once-daily doses of mevidalen (10 mg, 30 mg, or 75 mg) or placebo. Key study eligibility requirements were age of 40-85 years, Hoehn and Yahr score of 0-4, and Montreal Cognitive Assessment (MoCA) score of 10 to 23. The primary outcome measure was change from baseline on the Cognitive Drug Research Continuity of Attention (CDR-CoA) composite score using a Bayesian mixed model repeated measures (MMRM) model. Success criterion was defined as at least a 67% probability of an effect size (ES)≥0.2. Secondary outcomes included Alzheimer’s Disease Assessment Scale cognitive subscale 13 (ADAS-cog13), Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC), Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), and Epworth Sleepiness Scale (ESS). Numerous safety measures were collected.
Primary and secondary outcomes measures and key safety outcomes will be presented. 
The PRESENCE study assessed the safety and efficacy of mevidalen as a potential symptomatic cognitive treatment in Lewy Body Dementia. Secondary measures across several domains potentially affected by mevidalen and relevant to LBD were also assessed including cognition, function, motor, and sleep.
Authors/Disclosures
Kevin M. Biglan, MD (Eli Lilly)
PRESENTER 		Dr. Biglan has received personal compensation for serving as an employee of Eli Lilly. Dr. Biglan has received stock or an ownership interest from Eli Lilly.
Leanne Munsie Leanne Munsie has received personal compensation for serving as an employee of Eli Lilly and Company. Leanne Munsie has received stock or an ownership interest from Eli Lilly and Company.
Kjell Svensson Kjell Svensson has received personal compensation for serving as an employee of Eli Lilly.
Paul Ardayfio Paul Ardayfio has received personal compensation for serving as an employee of Eli Lilly and Co.. Paul Ardayfio has stock in Eli Lilly and Co.
No disclosure on file
John R. Sims, MD (Eli Lilly) Dr. Sims has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Sims has stock in Eli Lilly and Company.
Mark A. Mintun, MD Dr. Mintun has received personal compensation for serving as an employee of Eli Lilly & Co.