Skip to main content
Delfa

← Trials/Trial dossier/NCT02442778

CompletedPhase 3Results posted

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Asset

AVP-786

Listed sites

83

Recruiting sites

-

Enrollment

522

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 6-26•Study partner/caregiver required

Primary endpoint

•The Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID15-AVP-786-302
NCT IDNCT02442778

Timeline

Milestones

Study first posted2015-05-13estimated
Study start2015-11-11actual
Primary completion2019-08-14actual
Study completion2019-09-09actual
Last update posted2022-09-09actual
Results first posted2022-09-09actual

Assets

Drug assets

AVP-786

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (36)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
18
Caregiver / quality of life
10
Other clinical outcomes
4
Global cognition
2
Other (unclassified)
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Change From Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=143 Participants-2.05.67
AVP-786-28n=91 Participants-1.07.36
AVP-786-42.63n=97 Participants-1.56.38
LS Mean Difference1.095% CI-0.6 - 2.6p0.236MMRM
LS Mean Difference0.395% CI-1.3 - 1.9p0.684MMRM

Behavior / neuropsychiatric

18 endpoints
Primary/protocol endpoint

Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

Time frame:Baseline, Week 12

change from baseline, improvement

Primary/registry result

Change From Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
PlaceboBaselinen=210 Participants73.721.13
Change from Baseline at Week 12n=188 Participants-16.216.97
AVP-786-28Baselinen=150 Participants68.819.39
Change from Baseline at Week 12n=120 Participants-12.716.21
AVP-786-42.63Baselinen=159 Participants71.320.87
Change from Baseline at Week 12n=141 Participants-17.016.12
Least Squares (LS) Mean Difference0.495% CI-2.7 - 3.5p0.789MMRM
LS Mean Difference-2.095% CI-5.0 - 1.0p0.200MMRM
Secondary/protocol endpoint

Relative Change From Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score

Time frame:Baseline, Week 12

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the NPI Agitation/Aggression Caregiver Distress Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the NPI Irritability/Lability Domain Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the NPI Total Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/registry result

Relative Change From Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score

Time frame:Baseline, Week 12

percent change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=190 Participants2.91.18
AVP-786-28n=118 Participants3.11.23
AVP-786-42.63n=141 Participants2.81.20
LS Mean Difference0.195% CI-0.2 - 0.4p0.484MMRM
LS Mean Difference-0.195% CI-0.3 - 0.2p0.704MMRM
Secondary/registry result

Change From Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=192 Participants-2.53.17
AVP-786-28n=123 Participants-2.33.32
AVP-786-42.63n=148 Participants-3.23.32
LS Mean Difference-0.395% CI-0.9 - 0.4p0.416MMRM
LS Mean Difference-0.695% CI-1.3 - 0.0p0.066MMRM
Secondary/registry result

Change From Baseline to Week 12 in the NPI Agitation/Aggression Caregiver Distress Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=189 Participants-0.81.44
AVP-786-28n=121 Participants-0.81.61
AVP-786-42.63n=144 Participants-0.81.47
LS Mean Difference-0.295% CI-0.5 - 0.1p0.249MMRM
LS Mean Difference-0.295% CI-0.5 - 0.1p0.199MMRM
Secondary/registry result

Change From Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=192 Participants-1.23.75
AVP-786-28n=123 Participants-1.23.60
AVP-786-42.63n=148 Participants-1.83.57
LS Mean Difference0.095% CI-0.7 - 0.7p0.975MMRM
LS Mean Difference-0.395% CI-1.0 - 0.3p0.334MMRM
Secondary/registry result

Change From Baseline to Week 12 in the NPI Irritability/Lability Domain Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=192 Participants-1.83.50
AVP-786-28n=123 Participants-1.23.55
AVP-786-42.63n=148 Participants-2.23.29
LS Mean Difference-0.095% CI-0.7 - 0.6p0.888MMRM
LS Mean Difference-0.795% CI-1.3 - -0.1p0.019MMRM
Secondary/registry result

Change From Baseline to Week 12 in the NPI Total Score

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=192 Participants-12.317.06
AVP-786-28n=123 Participants-9.518.41
AVP-786-42.63n=148 Participants-16.918.05
LS Mean Difference0.695% CI-2.9 - 4.0p0.756MMRM
LS Mean Difference-3.695% CI-7.0 - -0.2p0.038MMRM
Secondary/registry result

Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=190 Participants-0.70.85
AVP-786-28n=118 Participants-0.70.92
AVP-786-42.63n=141 Participants-0.80.93
LS Mean Difference-0.195% CI-0.3 - 0.1p0.468MMRM
LS Mean Difference-0.195% CI-0.3 - 0.1p0.158MMRM
Secondary/registry result

Change From Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=189 Participants-1.12.84
AVP-786-28n=118 Participants-0.52.90
AVP-786-42.63n=141 Participants-1.52.57
LS Mean Difference0.695% CI0.0 - 1.2p0.038MMRM
LS Mean Difference-0.095% CI-0.6 - 0.5p0.911MMRM

Caregiver / quality of life

10 endpoints
Secondary/protocol endpoint

Change From Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Resource Utilization in Dementia (RUD) Score: Number of Hours Per Day the Caregiver Spent Assisting the Participant

Time frame:Week 12

event count, event

Secondary/protocol endpoint

Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant

Time frame:Week 12

event count, event

Secondary/protocol endpoint

Resource Utilization in Dementia (RUD) Score: Number of Visits to Hospital, Emergency, and Healthcare Professional

Time frame:Week 12

event count, event

Secondary/registry result

Change From Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=190 Participants-1.779.275
AVP-786-28n=118 Participants-1.0312.195
AVP-786-42.63n=141 Participants-0.2311.769
LS Mean Difference-0.195% CI-2.4 - 2.2p0.934MMRM
LS Mean Difference1.195% CI-1.2 - 3.4p0.342MMRM
Secondary/registry result

Change From Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=153 Participants2.911.10
AVP-786-28n=96 Participants3.88.10
AVP-786-42.63n=117 Participants3.28.74
LS Mean Difference0.395% CI-1.8 - 2.4p0.782MMRM
LS Mean Difference-0.095% CI-2.1 - 2.0p0.991MMRM
Secondary/registry result

Resource Utilization in Dementia (RUD) Score: Number of Hours Per Day the Caregiver Spent Assisting the Participant

Time frame:Week 12

event count, event

Posted result

GroupValue (median), hoursReported bounds
PlaceboQ1n=173 Participants3.0-0 - 24
Q2n=173 Participants4.5-0 - 24
Q3n=173 Participants5.0-0 - 24
AVP-786-28Q1n=111 Participants3.0-0 - 18
Q2n=111 Participants5.0-0 - 24
Q3n=111 Participants4.0-0 - 24
AVP-786-42.63Q1n=136 Participants3.0-0 - 24
Q2n=136 Participants5.0-0 - 24
Q3n=136 Participants6.0-0 - 24
Secondary/registry result

Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant

Time frame:Week 12

event count, event

Posted result

GroupValue (median), daysReported bounds
PlaceboQ1n=173 Participants30.0-0 - 30
Q2n=173 Participants30.0-0 - 30
Q3n=173 Participants30.0-0 - 30
AVP-786-28Q1n=111 Participants30.0-0 - 30
Q2n=111 Participants30.0-0 - 30
Q3n=111 Participants30.0-0 - 30
AVP-786-42.63Q1n=136 Participants30.0-0 - 30
Q2n=136 Participants30.0-0 - 30
Q3n=136 Participants30.0-0 - 30
Secondary/registry result

Resource Utilization in Dementia (RUD) Score: Number of Visits to Hospital, Emergency, and Healthcare Professional

Time frame:Week 12

event count, event

Posted result

GroupValue (mean), Number of visitsStandard deviation
PlaceboQ1n=4 Participants1.00.0
Q2n=1 Participants1.0NA
Q3n=173 Participants2.71.35
Q4n=167 Participants2.20.88
AVP-786-28Q1n=3 Participants1.30.58
Q3n=109 Participants2.51.28
Q4n=101 Participants2.10.51
AVP-786-42.63Q1n=3 Participants1.30.58
Q2n=2 Participants1.00.00
Q3n=130 Participants2.61.45
Q4n=126 Participants2.00.59

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint

Change From Baseline to Week 12 in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Overall Rating

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline to Week 12 in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Overall Rating

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=188 Participants3.21.20
AVP-786-28n=118 Participants3.41.31
AVP-786-42.63n=141 Participants3.11.23
LS Mean Difference0.195% CI-0.2 - 0.4p0.400MMRM
LS Mean Difference-0.195% CI-0.3 - 0.2p0.566MMRM
Secondary/registry result

Change From Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebon=191 Participants3.11.01
AVP-786-28n=118 Participants3.11.07
AVP-786-42.63n=141 Participants2.91.05
LS Mean Difference0.095% CI-0.2 - 0.3p0.751MMRM
LS Mean Difference-0.195% CI-0.3 - 0.1p0.320MMRM

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Number of Participants With the Change From Baseline in the General Medical Health Rating (GMHR) Score at Week 12

Time frame:Week 12

change from baseline, improvement

Secondary/registry result/low confidence

Number of Participants With the Change From Baseline in the General Medical Health Rating (GMHR) Score at Week 12

Time frame:Week 12

change from baseline, improvement

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
PlaceboFair to Excellent to Very Goodn=210 Participants6-
Poor to Excellent to Very Goodn=210 Participants22-
Good to Goodn=210 Participants17-
Fair to Goodn=210 Participants80-
Poor to Goodn=210 Participants6-
Missing to Goodn=210 Participants1-
Good to Fairn=210 Participants53-
Fair to Fairn=210 Participants11-
Poor to Fairn=210 Participants0-
Fair to Poorn=210 Participants1-
Good to Missingn=210 Participants5-
Fair to Missingn=210 Participants7-
Poor to Missingn=210 Participants1-
AVP-786-28Fair to Excellent to Very Goodn=150 Participants6-
Poor to Excellent to Very Goodn=150 Participants7-
Good to Goodn=150 Participants9-
Fair to Goodn=150 Participants65-
Poor to Goodn=150 Participants6-
Missing to Goodn=150 Participants0-
Good to Fairn=150 Participants31-
Fair to Fairn=150 Participants6-
Poor to Fairn=150 Participants3-
Fair to Poorn=150 Participants0-
Good to Missingn=150 Participants4-
Fair to Missingn=150 Participants9-
Poor to Missingn=150 Participants4-
AVP-786-42.63Fair to Excellent to Very Goodn=158 Participants3-
Poor to Excellent to Very Goodn=158 Participants10-
Good to Goodn=158 Participants10-
Fair to Goodn=158 Participants65-
Poor to Goodn=158 Participants4-
Missing to Goodn=158 Participants0-
Good to Fairn=158 Participants43-
Fair to Fairn=158 Participants11-
Poor to Fairn=158 Participants1-
Fair to Poorn=158 Participants0-
Good to Missingn=158 Participants7-
Fair to Missingn=158 Participants4-
Poor to Missingn=158 Participants0-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.