Pimavanserin alone or in combination for use in the treatment of Alzheimer's disease psychosis
Inventors
Coate, Bruce Duane • Owen, James Randall • Knowles, Mark Donald • Stankovic, Srdjan R. • Youakim, James M.
Assignees
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Publication Number
US-11464768-B2
Publication Date
2022-10-11
Expiration Date
Abstract
Methods for the treatment of Alzheimer's disease psychosis, or a symptom thereof, comprising administering pimavanserin. Also provided herein are methods for the treatment of delusions and/or hallucinations in a human with dementia comprising administering pimavanserin, or a pharmaceutically acceptable salt thereof. Also provided herein are methods for reducing NPI-NH score in a human with Alzheimer's Disease comprising administering pimavanserin, or a pharmaceutically acceptable salt thereof. Also provided herein are methods for reducing agitated behavior or aggressive behavior in a human with dementia comprising administering pimavanserin, or a pharmaceutically acceptable salt thereof.
Core Innovation
The invention describes methods using pimavanserin to treat delusions and/or hallucinations in a human with dementia. The method comprises orally administering 34 mg pimavanserin to the human and selecting the human based on baseline NPI-NH scores, including a baseline score of 12 or greater in the Psychosis subscale (Domains A and B) and/or a baseline score of 6 or greater in the Agitation/Aggression subscale (Domain C).
The invention defines treatment effect by an improved patient score in the NPI-NH of at least 4 points as compared to the baseline score prior to administering pimavanserin. The clinical evaluation includes the psychosis Domains A and B, the agitation Domain C, and additional related NPI-NH subscales such as sleep/nighttime (Domain K), with instruments and endpoints including CMAI, CMAI-SF, ADCS-CGIC, and ADCS-ADL.
The invention includes a clinical trial example using a randomized, double-blind, placebo-controlled design with pimavanserin administered at 34 mg daily, and reports statistically significant NPI-NH psychosis improvements in specified baseline subgroups. Salt and formulation aspects are included, including pimavanserin tartrate, and the invention describes optional contexts involving anti-Alzheimer’s agents.
Claims Coverage
The claim set covers a treatment method using orally administered 34 mg pimavanserin for delusions and/or hallucinations in a human with dementia, with patient selection based on specific NPI-NH baseline thresholds and treatment response defined by at least a 4-point NPI-NH improvement versus baseline. Dependent claims add timing, statistical, formulation, and co-therapy refinements.
Oral administration of 34 mg pimavanserin for delusions and/or hallucinations in dementia
A method for the treatment of delusions and/or hallucinations in a human with dementia, comprising orally administering 34 mg of pimavanserin to the human.
NPI-NH baseline thresholds for eligibility
The human has a baseline score of 12 or greater in the Psychosis subscale (Domains A and B) of the NPI-NH; or has a baseline score of 6 or greater in the Agitation/Aggression subscale (Domain C) of the NPI-NH.
NPI-NH improvement of at least 4 points versus baseline
The effect of the treatment is determined by an improved patient score in the NPI-NH of at least 4 points as compared to baseline score prior to administering pimavanserin.
Assessment of improvement after about 6 weeks
The effect is determined by an improved patient score at least about 6 weeks after initial administration of pimavanserin.
Statistical criterion for improvement p-value range
The improvement has a p-value between 0.0001 and 0.05.
Use of pimavanserin tartrate
The method involves administering a tartrate salt of pimavanserin to a human.
Concomitant administration with an anti-Alzheimer's agent
Pimavanserin is administered during concomitant administration of an anti-Alzheimer's agent.
Overall, the claim set covers a dementia treatment method using oral 34 mg pimavanserin for delusions and/or hallucinations, with selection by NPI-NH Psychosis and/or Agitation/Aggression thresholds and response defined by at least a 4-point NPI-NH improvement versus baseline. Dependent claims further specify timing, statistical p-value range, pimavanserin tartrate, and concomitant administration with an anti-Alzheimer’s agent.
Stated Advantages
Statistically significant NPI-NH psychosis improvements in specified baseline subgroups.
Reported safety and tolerability, including no cognitive impairment reported in the provided summary.
Documented Applications
Treatment of delusions and/or hallucinations in a human with dementia, including selection based on NPI-NH psychosis and/or agitation/aggression subscale baseline thresholds.
Clinical evaluation using NPI-NH, including psychosis domains, agitation domain, and sleep/nighttime domain, and additional instruments/endpoints CMAI, CMAI-SF, ADCS-CGIC, and ADCS-ADL.
Optionally used in a context involving concomitant administration of an anti-Alzheimer’s agent.
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