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Phase 3 N=387 Randomized Quadruple-blind Treatment

Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Agitation in Patients With Dementia of the Alzheimer's Type

Bottom Line

View on ClinicalTrials.gov: NCT02442765 ↗
Enrolled (actual)
387
Serious AEs
5.9%
Results posted
Feb 2023
Primary outcome: Primary: Stage 1 and Stage 2: Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score to Week 6 and Week 12 — 73.9; 72.3; 71.7; -10.7 units on a scale — p==0.021

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
AVP-786 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion
Jan 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Stage 1 and Stage 2: Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score to Week 6 and Week 12		 73.9; 72.3; 71.7; -10.7; -13.9; -10.3 =0.021 sig
SECONDARY
Least Squares Mean Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score at Week 6 and Week 12		 3.4; 3.2; 3.3; 3.9; 3.3; 3.5 0.331
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score to Week 6 and Week 12		 7.1; 6.5; 7.2; -1.8; -2.0; -2.1 =0.182
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the NPI Caregiver Distress Score to Week 6 and Week 12		 18.87; 18.90; 18.88; -4.31; -5.48; -4.83 =0.247
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the NPI Aberrant Motor Behavior Domain Score to Week 6 and Week 12		 5.1; 4.9; 5.1; -0.9; -1.6; -0.7 =0.146
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the Zarit Burden Interview (ZBI) Score to Week 6 and Week 12		 30.9; 30.0; 33.0; -1.4; -2.0; -2.7 =0.530
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the NPI Irritability/Lability Domain Score to Week 6 and Week 12		 5.1; 5.1; 5.2; -1.1; -1.9; -1.4 =0.061
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the NPI Total Score to Week 6 and Week 12		 40.2; 39.4; 40.1; -9.2; -13.2; -10.6 =0.050
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score to Week 6 and Week 12		 4.5; 4.3; 4.4; -0.5; -0.7; -0.7 =0.118
SECONDARY
Stage 1 and Stage 2: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Rating at Week 6 and Week 12		 3.7; 3.5; 3.6; 4.0; 3.6; 3.7 =0.364
SECONDARY
Stage 1 and Stage 2: Patient Global Impression of Change (PGIC) Score at Week 6 and Week 12		 3.4; 3.0; 3.1; 3.6; 3.1; 3.3 =0.014 sig
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the Dementia Quality of Life (DEMQOL) Score to Week 6 and Week 12		 85.7; 82.9; 84.0; 2.3; 3.5; 4.4 =0.909
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score to Week 6 and Week 12		 6.2; 6.3; 6.4; -0.3; -0.7; -0.5 =0.278
SECONDARY
Stage 2: Percentage of Participants With General Medical Health Rating (GMHR) Score		 22.6; 20.3; 13.8; 20.2; 20.6; 59.7 —
SECONDARY
Stage 1 and Stage 2: Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score to Week 6 and Week 12		 25.8; 26.2; 25.3; -0.5; -2.0; -0.5 =0.018 sig
SECONDARY
Stage 1: Resource Utilization in Dementia (RUD): Percentage of Caregiver Who Reported That Their Responsibilities Affected Their Work and Who Visited Health Care Professionals		 33.8; 22.9; 34.2; 42.2; 31.1; 44.8 —
SECONDARY
Stage 2: Resource Utilization in Dementia (RUD): Percentage of Caregiver Who Reported That Their Responsibilities Affected Their Work and Who Visited Health Care Professionals		 44.0; 28.6; 36.4; 24.2; 35.3; 43.1 —
SECONDARY
Stage 1: Resource Utilization in Dementia (RUD): Number of Hours Per Day the Caregiver Spent Assisting the Participant		 2.0; 2.0; 2.0; 4.0; 4.0; 4.0 —
SECONDARY
Stage 2: Resource Utilization in Dementia (RUD): Number of Hours Per Day the Caregiver Spent Assisting the Participant		 1.5; 2.0; 2.0; 2.0; 2.0; 4.0 —
SECONDARY
Stage 1: Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant		 30.0; 30.0; 30.0; 30.0; 30.0; 30.0 —
SECONDARY
12-Week Parallel Group: Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant		 30.0; 30.0; 30.0; 30.0; 30.0; 30.0 —

Summary

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
  • The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Either out patients or residents of an assisted-living facility or a skilled nursing home
  • Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >= 4 (moderately ill) at screening and baseline
  • Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria

  • Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participant with myasthenia gravis
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02442765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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