Trial · NCT02446132

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

NCT02446132, Phase 3, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-10-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type. Trials, record NCT02446132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02446132

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Trial

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

Title: Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT number: NCT02446132
Status: Terminated
Phases: Phase 3
Enrollment: 1,197 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
Interventions: AVP-786
First posted: 2015-05-18
Last updated: 2025-10-15
Other registries' IDs: eudract:2017-002455-29
Results first posted: 2025-10-15
Limitations and caveats: The study was prematurely terminated due to discontinuation of development of the AVP-786 compound.

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)	An adverse event (AE)is any untoward medical occurrence or unintended change (e.g. physical, psychological, or behavioral), including inter-current illness, whether considered related to treatment or not. An AE can therefore be any unfavorable and unintended sign (including any clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.
Primary	Number of Participants With Serious TEAE	From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)	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. A serious TEAE is defined as AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.
Primary	Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities	Baseline (current study) up to 52 weeks	Laboratory assessments included clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, cholesterol, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, protein, potassium, sodium, triglycerides and uric acid), hematology (basophils, eosinophils/leukocytes, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils/leukocytes, platelets). Number of participants with clinically significant laboratory test abnormalities were reported as per criteria defined in statistical analysis plan (SAP). The categories with at least one participant with potentially clinically significant laboratory values are reported.
Primary	Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities	Baseline (current study) up to 52 weeks	A resting 12-lead ECG was performed for all the participants. ECG data included PR interval (milliseconds {msec}) and QTcF (msec) along with change from baseline in QTcF. Number of participants with potentially clinically significant ECG abnormalities was reported as per the criteria defined in SAP.
Primary	Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding	Baseline (current study), Week 52	The physical examination included assessments of head, eyes, ears, nose, throat, lymph nodes, skin, extremities, respiratory, gastrointestinal, musculoskeletal, cardiovascular, and nervous systems. The neurological examination included assessments of mental status, cranial nerves, motor system, reflexes, coordination, gait and station, and sensory system.
Primary	Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs	Baseline (current study) up to 52 weeks	Vital signs measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). Blood pressure (i.e., SBP, DBP) and heart rate were measured in the supine and standing positions after the participant had been in each position for at least 5 and 3 minutes, respectively. Number of participants with clinically significant vital sign abnormalities were reported as per criteria defined in SAP. The categories with at least one participant with clinically significant vital signs abnormalities are reported here.
Primary	Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64	Baseline (current study), Week 64	The S-STS is a prospective scale that assesses treatment-emergent suicidal thoughts and behaviors. This is a 20-item scale where each item (except item 17) of the S-STS is scored on a 5-point Likert scale as: 0 = Not at all, 1 = A little, 2 = Moderate, 3 = Very, 4 = Extremely. The S-STS total score is calculated by the sum of items 1a (if present), items 2-11, highest score of item 12 or 16, highest score of item 14 or 15, item 17 and 20. The total score ranges from 0 to 156 (If response to S-STS item 17 =yes, a score of 100 was added to the S-STS total score). Higher scores indicate greater severity of suicidal ideation and/or behavior. A negative change from baseline reflects a reduction in suicidal thoughts or behaviors over time.
Primary	Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52	Baseline (current study), Week 52	The MMSE is a brief questionnaire that is used to assess cognitive impairment and severity of cognitive impairment. The MMSE scale comprises 11 questions or simple tasks concerning orientation, memory, attention, and language to evaluate a participant's cognitive state and are scored as follows: Orientation to Time - 0 to 5; Orientation to Place - 0 to 5; Registration - 0 to 3; Attention and Calculation - 0 to 5; Recall - 0 to 3; Naming - 0 to 2; Repetition - 0 to 1; Comprehension - 0 to 3; Reading - 0 to 1; Writing - 0 to 1; Drawing - 0 to 1. The total score was calculated by summing all of the item scores and ranges from 0 to 30. Higher scores indicate milder cognitive impairment. Negative change from baseline indicates decline in cognitive performance.
Primary	Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52	Baseline (current study), Week 52	The ESS is an 8-item questionnaire that is used to measure sleepiness by rating the probability of falling asleep on 8 different situations that most people engage in during the day. The 8 questions are rated on a 4-point scale (0 to 3) where 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. The scores are summed to give an overall score of 0 to 24. A total score of 0 to 9 is considered to be normal. Higher score indicates greater daytime sleepiness. Negative change from baseline indicate improvement in daytime sleepiness.
Secondary	Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score at Week 64	Baseline (current study), Week 64	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.

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	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)	Safety population included all participants who received the study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Serious TEAE	From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)	Safety population included all participants who received the study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities	Baseline (current study) up to 52 weeks	Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities	Baseline (current study) up to 52 weeks	Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding	Baseline (current study), Week 52	Safety population included all participants who received the study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs	Baseline (current study) up to 52 weeks	Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64	Baseline (current study), Week 64	Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point.	score on a scale	MEAN
PRIMARY	Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52	Baseline (current study), Week 52	Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point.	score on a scale	MEAN
PRIMARY	Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52	Baseline (current study), Week 52	Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point.	score on a scale	MEAN
SECONDARY	Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score at Week 64	Baseline (current study), Week 64	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.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group210

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 (TEAEs)	AVP-786 18 mg		109	Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	AVP-786 28 mg		304	Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	AVP-786 42.63 mg		292	Participants
Number of Participants With Serious TEAE	AVP-786 18 mg		22	Participants
Number of Participants With Serious TEAE	AVP-786 28 mg		75	Participants
Number of Participants With Serious TEAE	AVP-786 42.63 mg		70	Participants
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities	AVP-786 18 mg	Alanine Aminotransferase (units per litre {U/L}): ≥3X ULN	1	Participants
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities	AVP-786 28 mg	Alanine Aminotransferase (units per litre {U/L}): ≥3X ULN	0	Participants
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities	AVP-786 42.63 mg	Alanine Aminotransferase (units per litre {U/L}): ≥3X ULN	1	Participants
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities	AVP-786 18 mg	Albumin (grams per litre {g/L}): ≤26 g/L	3	Participants

1 to 10 of 210Source ClinicalTrials.gov

See all 210 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AVP-786 18 18 Milligrams (mg)	166
Overall Study	STARTED	AVP-786 28 mg	517
Overall Study	STARTED	AVP-786 42.63 mg	514
Overall Study	COMPLETED	AVP-786 18 18 Milligrams (mg)	109
Overall Study	COMPLETED	AVP-786 28 mg	332
Overall Study	COMPLETED	AVP-786 42.63 mg	324
Overall Study	NOT COMPLETED	AVP-786 18 18 Milligrams (mg)	57
Overall Study	NOT COMPLETED	AVP-786 28 mg	185
Overall Study	NOT COMPLETED	AVP-786 42.63 mg	190

Source ClinicalTrials.gov

Adverse events546

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	AVP-786 18 mg	10	166
other	Diarrhoea	Gastrointestinal disorders	AVP-786 28 mg	28	516
other	Diarrhoea	Gastrointestinal disorders	AVP-786 42.63 mg	26	509
other	Urinary tract infection	Infections and infestations	AVP-786 18 mg	13	166
other	Urinary tract infection	Infections and infestations	AVP-786 28 mg	45	516
other	Urinary tract infection	Infections and infestations	AVP-786 42.63 mg	43	509
other	Contusion	Injury, poisoning and procedural complications	AVP-786 18 mg	10	166
other	Contusion	Injury, poisoning and procedural complications	AVP-786 28 mg	16	516
other	Contusion	Injury, poisoning and procedural complications	AVP-786 42.63 mg	11	509
other	Fall	Injury, poisoning and procedural complications	AVP-786 18 mg	27	166

1 to 10 of 546Source ClinicalTrials.gov

See all 546 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AVP-786 18 mg	4	166
Total, all-cause mortality	AVP-786 28 mg	22	516
Total, all-cause mortality	AVP-786 42.63 mg	16	509
Total, other adverse events	AVP-786 18 mg	54	166
Total, other adverse events	AVP-786 28 mg	150	516
Total, other adverse events	AVP-786 42.63 mg	149	509
Total, serious adverse events	AVP-786 18 mg	22	166
Total, serious adverse events	AVP-786 28 mg	75	516
Total, serious adverse events	AVP-786 42.63 mg	70	509

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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