Trial · NCT02442778

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

NCT02442778, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2022-09-09

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type. Trials, record NCT02442778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02442778

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
NCT number: NCT02442778
Status: Completed
Phases: Phase 3
Enrollment: 522 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Agitation in Participants With Dementia of the Alzheimer's Type
Interventions: AVP-786-18, Placebo, AVP-786-28, AVP-786-42.63
First posted: 2015-05-13
Last updated: 2022-09-09
Results first posted: 2022-09-09

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Baseline, Week 12	The CMAI was used to assess the frequency of manifestations of agitated behaviors in elderly participants. It consists of 29 agitated items rated on a 7-point scale of frequency: 1, never; 2, less than once a week; 3, once or twice a week; 4, several times a week; 5, once or twice a day; 6, several times a day; 7, several times an hour. The CMAI total score ranges from 29 to 203. Higher scores indicate worsening of the condition. Negative change from baseline indicates improvement. Mixed Model Repeated Measures (MMRM) was used for the analysis.
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	Baseline, Week 12	The mADCS-CGIC-Agitation is a modified version of the ADCS-CGIC containing additional questions related to agitation and an assessment of the Clinician's Impression of Change focused specifically on agitation. Participants are asked to rate their impression of change as: 1=Marked Improvement; 2=Moderate Improvement; 3=Minimal Improvement; 4=No Change; 5=Minimal Worsening; 6=Moderate Worsening; 7=Marked Worsening. Higher scores indicate worsening of agitation and positive change from baseline indicates worsening. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score	Baseline, Week 12	The NPI is a retrospective caregiver-informant interview covering 12 neuropsychiatric symptom domains. The Agitation/Aggression domain is designed to collect information on the behavioral aspects of agitation/aggression in participants with probable AD and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as:1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, severe. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. Higher scores indicate worsening symptoms. Negative change from baseline indicates improvement in symptoms. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the NPI Agitation/Aggression Caregiver Distress Score	Baseline, Week 12	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as:1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as:1, mild; 2, moderate; 3, marked severe. The total caregiver distress score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12 with a higher score indicating worsening of symptoms. Negative change from baseline indicates improvement in symptoms. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score	Baseline, Week 12	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate aberrant motor behavior. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked severe. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12 with a higher score indicating worsening of symptoms. Negative change from baseline indicates improvement in symptoms. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score	Baseline, Week 12	The ZBI is a 22-item scale used to assess the impact of a participants' disabilities on the caregiver's life. It is designed to reflect the burden experienced by caregivers of dementia participants and can either be completed by the caregiver or administered as an interview. Each item of the scale is rated to reflect the burden using the 5-point scale: 0=Never; 1=Rarely; 2=Sometimes; 3=Quite Frequently; 4=Nearly Always. The ZBI is scored by summing the responses of the individual questions and ranges from 0 to 88. Higher scores indicate greater caregiver distress. Negative change from baseline indicates less distress. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the NPI Irritability/Lability Domain Score	Baseline, Week 12	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains, including the irritability/lability domain score. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as:1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as:1, mild; 2, moderate; 3, severe. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. Higher scores indicate worsening of the symptoms. Negative change from baseline indicates improvement in symptoms. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the NPI Total Score	Baseline, Week 12	NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, night time behaviors, as well as appetite/eating. Total domain score= frequency x severity and thus ranges from 1 to 12. NPI domain is rated by caregiver for symptom frequency and severity. Frequency is rated as:1=occasionally, 2=often, 3= frequently, and 4=very frequently. Severity is rated as:1=mild,2=moderate,3=severe. Frequency and severity rating scales has defined anchor points to enhance reliability of caregiver responses. Caregiver distress is rated for each positive neuropsychiatric symptom using following anchored scores. It is rated as 0=not at all,1=minimal,2=mild,3=moderate,4=severe,5=very severe. Individual Item scores are added to yield a possible total score of 0 to 144. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score	Baseline, Week 12	The CGIS-Agitation is an observer-rated scale that measures illness severity. The CGIS-Agitation is a 7-point (1-7) scale (1=normal, not at all ill participants; 7=among the most extremely ill participants) and is assessed for severity of agitation. A value of 0 is given to participants who are not assessed. Higher scores indicate poor health of participants. MMRM was used for the analysis.
Secondary	Change From Baseline to Week 12 in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Overall Rating	Baseline, Week 12	The ADCS-CGIC rating scale provides a reliable means to assess change from a Baseline level of global function within the time frame of the trial. ADCS-CGIC-Overall focuses on the clinician's observations of change in the participant's cognitive, functional, and behavioral performance. The ADCS-CGIC-Overall responses (1-7) are rated as: 1 = marked improvement, 2 = moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, or 7 = marked worsening. MMRM was used for the analysis.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Number analysed signifies the number of participants with available data for analysis at a specific timepoint.	score on a scale	MEAN
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	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Overall number of participants analysed signifies the number of participants with available data for analysis at specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Number analysed signifies the number of participants with available data for analysis at a specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the NPI Agitation/Aggression Caregiver Distress Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Overall number of participants analysed signifies the number of participants with available data for analysis at a specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Number analysed signifies the number of participants with available data for analysis at a specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Overall number of participants analysed signifies the number of participants with available data for analysis at a specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the NPI Irritability/Lability Domain Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Overall number of participants analysed signifies the number of participants with available data for analysis at specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the NPI Total Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Overall number of participants analysed signifies the number of participants with available data for analysis at a specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Overall number of participants analysed signifies the number of participants with available data for analysis at specific timepoint.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Overall Rating	Baseline, Week 12	mITT Population included all randomized participants who had at least one post-baseline efficacy assessment. Participants were included in the treatment group to which they were randomized regardless of treatment received. Overall number of participants analysed signifies the number of participants with available data for analysis at a specific timepoint.	score on a scale	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group113

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Placebo	Baseline	73.7	Standard Deviation 21.13	score on a scale
Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	AVP-786-28	Baseline	68.8	Standard Deviation 19.39	score on a scale
Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	AVP-786-42.63	Baseline	71.3	Standard Deviation 20.87	score on a scale
Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Placebo	Change from Baseline at Week 12	-16.2	Standard Deviation 16.97	score on a scale
Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	AVP-786-28	Change from Baseline at Week 12	-12.7	Standard Deviation 16.21	score on a scale
Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	AVP-786-42.63	Change from Baseline at Week 12	-17.0	Standard Deviation 16.12	score on a scale
Relative Change From Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score	Placebo		2.9	Standard Deviation 1.18	score on a scale
Relative Change From Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score	AVP-786-28		3.1	Standard Deviation 1.23	score on a scale
Relative Change From Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score	AVP-786-42.63		2.8	Standard Deviation 1.20	score on a scale
Change From Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score	Placebo		-2.5	Standard Deviation 3.17	score on a scale

1 to 10 of 113Source ClinicalTrials.gov

See all 113 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	210
Overall Study	STARTED	AVP-786-28	151
Overall Study	STARTED	AVP-786-42.63	161
Overall Study	Safety Population	Placebo	210
Overall Study	Safety Population	AVP-786-28	151
Overall Study	Safety Population	AVP-786-42.63	160
Overall Study	Modified Intent-to-Treat (mITT) Population	Placebo	210
Overall Study	Modified Intent-to-Treat (mITT) Population	AVP-786-28	150
Overall Study	Modified Intent-to-Treat (mITT) Population	AVP-786-42.63	159
Overall Study	COMPLETED	Placebo	192

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events159

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Placebo	14	210
other	Diarrhoea	Gastrointestinal disorders	AVP-786-28	5	151
other	Diarrhoea	Gastrointestinal disorders	AVP-786-42.63	5	160
other	Urinary tract infection	Infections and infestations	Placebo	11	210
other	Urinary tract infection	Infections and infestations	AVP-786-28	10	151
other	Urinary tract infection	Infections and infestations	AVP-786-42.63	3	160
other	Fall	Injury, poisoning and procedural complications	Placebo	8	210
other	Fall	Injury, poisoning and procedural complications	AVP-786-28	15	151
other	Fall	Injury, poisoning and procedural complications	AVP-786-42.63	10	160
other	Somnolence	Nervous system disorders	Placebo	2	210

1 to 10 of 159Source ClinicalTrials.gov

See all 159 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	210
Total, all-cause mortality	AVP-786-28	3	151
Total, all-cause mortality	AVP-786-42.63	0	161
Total, other adverse events	Placebo	40	210
Total, other adverse events	AVP-786-28	31	151
Total, other adverse events	AVP-786-42.63	30	160
Total, serious adverse events	Placebo	10	210
Total, serious adverse events	AVP-786-28	15	151
Total, serious adverse events	AVP-786-42.63	8	160

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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