Lundbeck Q3 2019 Financial Results
Third study in brexpiprazole pivotal programme in agitation Alzheimer's
progresses as planned
Agitation in Alzheimer's (AAD)
>20% of individuals in a community setting and >50% of nursing home residents with dementia have agitation
*
*
1.5-2m dementia patients in the U.S. with agitation / aggression
x
No FDA approved medication
*
Associated with increased caregiver burden, decreased functioning, earlier nursing home placement
Study
objective¹)
To compare the efficacy of 2 doses of brexpiprazole with placebo in subjects with agitation
associated with dementia of the Alzheimer's type (n = ~225)
Third study out of three in the pivotal programme (phase III):
*
Brexpiprazole (fixed dose 2mg and 3mg) and placebo
★ Primary endpoint: Cohen-Mansfield Agitation Inventory (CMAI) total score (Week 12)
* Secondary endpoint: Clinical Global Impression Severity of Illness (CGI-S) score
*
Headline results due early 2021 - Fast Track designation granted February 2016
1) Clinicaltrials.gov ID: NCT03548584
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LundbeckView entire presentation