Phase 3 N=522 Randomized Quadruple-blind Treatment

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

Agitation in Participants With Dementia of the Alzheimer's Type

Bottom Line

View on ClinicalTrials.gov: NCT02442778 ↗

Enrolled (actual)

522

Serious AEs

6.3%

Results posted

Sep 2022

Primary outcome: Primary: Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score — 73.7; 68.8; 71.3; -16.2 score on a scale — p=0.789

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AVP-786-18 (Drug); Placebo (Drug); AVP-786-28 (Drug); AVP-786-42.63 (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	73.7; 68.8; 71.3; -16.2; -12.7; -17.0	0.789
SECONDARY Relative Change From Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score	2.9; 3.1; 2.8	0.484
SECONDARY Change From Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score	-2.5; -2.3; -3.2	0.416
SECONDARY Change From Baseline to Week 12 in the NPI Agitation/Aggression Caregiver Distress Score	-0.8; -0.8; -0.8	0.249
SECONDARY Change From Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score	-1.2; -1.2; -1.8	0.975
SECONDARY Change From Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score	-1.77; -1.03; -0.23	0.934
SECONDARY Change From Baseline to Week 12 in the NPI Irritability/Lability Domain Score	-1.8; -1.2; -2.2	0.888
SECONDARY Change From Baseline to Week 12 in the NPI Total Score	-12.3; -9.5; -16.9	0.756
SECONDARY Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score	-0.7; -0.7; -0.8	0.468
SECONDARY Change From Baseline to Week 12 in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Overall Rating	3.2; 3.4; 3.1	0.400
SECONDARY Change From Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Score	3.1; 3.1; 2.9	0.751
SECONDARY Change From Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Score	2.9; 3.8; 3.2	0.782
SECONDARY Change From Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score	-1.1; -0.5; -1.5	0.038 sig
SECONDARY Number of Participants With the Change From Baseline in the General Medical Health Rating (GMHR) Score at Week 12	6; 6; 3; 22; 7; 10	—
SECONDARY Change From Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score	-2.0; -1.0; -1.5	0.236
SECONDARY Resource Utilization in Dementia (RUD) Score: Number of Hours Per Day the Caregiver Spent Assisting the Participant	3.0; 3.0; 3.0; 4.5; 5.0; 5.0	—
SECONDARY 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 Resource Utilization in Dementia (RUD) Score: Number of Visits to Hospital, Emergency, and Healthcare Professional	1.0; 1.3; 1.3; 1.0; 1.0; 2.7	—

Summary

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will 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 participants 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 (NCT02442778). 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.