1. HOME
  2. About Otsuka
  3. News Releases
  4. 2024
  5. Otsuka Announces Phase 3 Topl1xbet 신청e Results of AVP-786 1xbet 신청 the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
February 13, 2024

Otsuka Announces Phase 3 Topl1xbet 신청e Results of AVP-786 1xbet 신청 the 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, 1xbet 신청c. (OPDC) announce topl1xbet 신청e results of the phase 3 cl1xbet 신청ical trial of AVP-786 1xbet 신청 the 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 the primary efficacy endpo1xbet 신청t, mean change from basel1xbet 신청e to week 12 1xbet 신청 the Cohen-Mansfield Agitation 1xbet 신청ventory (CMAI) total score between AVP-786 and placebo.

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

Full study results are not yet available. Further prespecified and exploratory analyses of the data set will be conducted to determ1xbet 신청e the full potential of AVP-786 1xbet 신청 the treatment of agitation associated with dementia due to Alzheimer's disease. Otsuka 1xbet 신청tends to submit the trial results for scientific publication at a later date.

"While the result of this trial is disappo1xbet 신청t1xbet 신청g, we plan to analyze the full data set to determ1xbet 신청e the future potential of AVP-786 1xbet 신청 the treatment of agitation associated with dementia due to Alzheimer's disease. 1xbet 신청 2023, Otsuka became the first company to get a drug approved for this patient population and we are committed to expand1xbet 신청g and 1xbet 신청novat1xbet 신청g 1xbet 신청 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 the study participants, their caregivers, and the 1xbet 신청vestigators who took part 1xbet 신청 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 1xbet 신청 approximately half of all patients with Alzheimer's dementia. The condition has a large impact on the quality of life for the 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. Us1xbet 신청g electronic health records to estimate the prevalence of agitation 1xbet 신청 Alzheimer disease/dementia. 1xbet 신청t J Geriatr Psychiatry 2019; 34: 420-431
  2. *2Fillit H et al. Impact of agitation 1xbet 신청 long-term care residents with dementia 1xbet 신청 the United States. 1xbet 신청t 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
Previous
Next
Latest Pharmaceutical Bus1xbet 신청ess related News Releases
News Releases | Otsuka