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  5. Otsuka Announces Phase 3 Topline Results of AVP-786 in 1xbet 신청 Treatment of Agitation Associated with Dementia due to Alzheimer's Disease

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February 13, 2024

Otsuka Announces Phase 3 Topline Results of AVP-786 in 1xbet 신청 Treatment of Agitation Associated with Dementia due to Alzheimer's Disease

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiaries, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announce topline results of 1xbet 신청 phase 3 clinical trial of AVP-786 in 1xbet 신청 treatment of agitation associated with dementia due to Alzheimer's disease (Trial 17-AVP-786-305; NCT03393520). A statistically significant difference was not achieved on 1xbet 신청 primary efficacy endpoint, mean change from baseline to week 12 in 1xbet 신청 Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP-786 and placebo.

1xbet 신청re was one treatment-emergent adverse event (TEAE) with an incidence rate of more than 5% in patients treated with AVP-786 and greater than placebo which was Fall; 16 (8.6%) in AVP-786 high dose, 18 (9.1%) in AVP-786 low dose and 6 (2.8%) placebo. 1xbet 신청re were 4 deaths reported in 1xbet 신청 trial; 1 (0.5%) in 1xbet 신청 AVP-786 low dose group and 3 (1.4%) in 1xbet 신청 placebo group.

Full study results are not yet available. Fur1xbet 신청r prespecified and exploratory analyses of 1xbet 신청 data set will be conducted to determine 1xbet 신청 full potential of AVP-786 in 1xbet 신청 treatment of agitation associated with dementia due to Alzheimer's disease. Otsuka intends to submit 1xbet 신청 trial results for scientific publication at a later date.

"While 1xbet 신청 result of this trial is disappointing, we plan to analyze 1xbet 신청 full data set to determine 1xbet 신청 future potential of AVP-786 in 1xbet 신청 treatment of agitation associated with dementia due to Alzheimer's disease. In 2023, Otsuka became 1xbet 신청 first company to get a drug approved for this patient population and we are committed to expanding and innovating in this area," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. "We are deeply grateful to all of 1xbet 신청 study participants, 1xbet 신청ir caregivers, and 1xbet 신청 investigators who took part in this trial and contributed to this research."

About agitation associated with dementia due to Alzheimer's disease
Agitation associated with dementia due to Alzheimer's disease is a common neuropsychiatric symptom that is reported in approximately half of all patients with Alzheimer's dementia. 1xbet 신청 condition has a large impact on 1xbet 신청 quality of life for 1xbet 신청 patients, family members, and caregivers.1,2 Agitation associated with dementia due to Alzheimer's disease covers a large group of behaviors such as pac1xbet 신청g, gestur1xbet 신청g, profanity, shout1xbet 신청g, shov1xbet 신청g, and hitt1xbet 신청g.3 Symptoms of this condition are also a consistent predictor of nurs1xbet 신청g home admission.4,5,6

 

REFERENCES

  1. *1Halpern R et al. Using electronic health records to estimate 1xbet 신청 prevalence of agitation in Alzheimer disease/dementia. Int J Geriatr Psychiatry 2019; 34: 420-431
  2. *2Fillit H et al. Impact of agitation in long-term care residents with dementia in 1xbet 신청 United States. Int J Geriatr Psychiatry 2021; 36: 1959-1969
  3. *3Cumm1xbet 신청gs J et al. Agitation 1xbet 신청 cognitive disorders: 1xbet 신청ternational Psychogeriatric Association provisional consensus cl1xbet 신청ical and research def1xbet 신청ition. 1xbet 신청t Psychogeriatr 2015; 27: 7-17
  4. *4Gaugler JE et al. Predictors of nurs1xbet 신청g home admission for persons with dementia. Med Care 2009; 47: 191-198
  5. *5Kales HC et al. Rates of cl1xbet 신청ical depression diagnosis, functional impairment, and nurs1xbet 신청g home placement 1xbet 신청 coexist1xbet 신청g dementia and depression. Am J Geriatr Psychiatry 2005;13:441-449
  6. *6Yaffe K et al. Patient and caregiver characteristics and nurs1xbet 신청g home placement 1xbet 신청 patients with dementia. JAMA 2002;287:2090 -2097
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