Trial · NCT04464564

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

NCT04464564, Phase 3, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-05-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type. Trials, record NCT04464564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04464564

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Trial

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

Title: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT number: NCT04464564
Status: Terminated
Phases: Phase 3
Enrollment: 241 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
Interventions: AVP-786, Placebo
First posted: 2020-07-09
Last updated: 2025-05-30
Other registries' IDs: eudract:2020-000799-39
Results first posted: 2025-05-30
Limitations and caveats: The study was prematurely terminated due to discontinuation of development of the AVP-786 compound.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change From the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Week 1 to Week 10	The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 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 ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviours while lower scores indicate lower frequency of agitated behaviours.
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16)	An adverse event (AE) is any untoward medical occurrence or unintended change (eg, physical, psychological, or behavioral), including inter-current illness, that does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. TEAEs are all AEs (including serious and non-serious) which started after start of double-blind study drug treatment; or if the event was continuous from baseline and was worsening, serious, study drug related, or resulted in death, discontinuation, interruption or reduction of study therapy.
Secondary	Change From the End of Period A (Week 1) to Week 10 in the Clinical Global Impression of Severity of Illness (CGIS) Score, as Related to Agitation	Week 1 to Week 10	The CGIS 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; 7 = among the most extremely ill patients) and assesses severity of agitation in this study. Higher scores indicate severe agitation while the lower scores indicate little or no agitation.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Week 1 to Week 10	Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified primary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed
PRIMARY	Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16)	Safety population included of all participants who were randomized in the double-blind period B of this study, and took at least one dose of double-blind, randomized study medication. As pre-specified in the Statistical Analysis Plan (SAP), safety data was planned to be collected only for the participants who were randomized in the double-blind period B of this study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From the End of Period A (Week 1) to Week 10 in the Clinical Global Impression of Severity of Illness (CGIS) Score, as Related to Agitation	Week 1 to Week 10	Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Units
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	Placebo	TEAEs	25	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	AVP-786-18	TEAEs	38	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	AVP-786-42.63	TEAEs	34	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	Placebo	Serious TEAEs	4	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	AVP-786-18	Serious TEAEs	5	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	AVP-786-42.63	Serious TEAEs	5	Participants

Source ClinicalTrials.gov

Participant flow28

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

Period	Milestone	Group	Participants
Period A (Placebo lead-in)	STARTED	All Enrolled	241
Period A (Placebo lead-in)	STARTED	Placebo	0
Period A (Placebo lead-in)	STARTED	AVP-786-18	0
Period A (Placebo lead-in)	STARTED	AVP-786-42.63	0
Period A (Placebo lead-in)	COMPLETED	All Enrolled	236
Period A (Placebo lead-in)	COMPLETED	Placebo	0
Period A (Placebo lead-in)	COMPLETED	AVP-786-18	0
Period A (Placebo lead-in)	COMPLETED	AVP-786-42.63	0
Period A (Placebo lead-in)	NOT COMPLETED	All Enrolled	5
Period A (Placebo lead-in)	NOT COMPLETED	Placebo	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events402

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	Anaemia	Blood and lymphatic system disorders	Placebo	0	76
other	Anaemia	Blood and lymphatic system disorders	AVP-786-18	1	83
other	Anaemia	Blood and lymphatic system disorders	AVP-786-42.63	0	77
other	Lymphopenia	Blood and lymphatic system disorders	Placebo	1	76
other	Lymphopenia	Blood and lymphatic system disorders	AVP-786-18	0	83
other	Lymphopenia	Blood and lymphatic system disorders	AVP-786-42.63	0	77
other	Neutropenia	Blood and lymphatic system disorders	Placebo	1	76
other	Neutropenia	Blood and lymphatic system disorders	AVP-786-18	0	83
other	Neutropenia	Blood and lymphatic system disorders	AVP-786-42.63	0	77
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	0	76

1 to 10 of 402Source ClinicalTrials.gov

See all 402 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	76
Total, all-cause mortality	AVP-786-18	0	83
Total, all-cause mortality	AVP-786-42.63	1	77
Total, other adverse events	Placebo	25	76
Total, other adverse events	AVP-786-18	38	83
Total, other adverse events	AVP-786-42.63	32	77
Total, serious adverse events	Placebo	4	76
Total, serious adverse events	AVP-786-18	5	83
Total, serious adverse events	AVP-786-42.63	5	77

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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