TerminatedPhase 3Results posted

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

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

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Asset

AVP-786

Listed sites

106

Recruiting sites

Enrollment

241

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoints

•Change From the End of Period A (Week 1)•Treatment Emergent Adverse Events (TEAE) and Serious TEAE

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 ID20-AVP-786-307

Eudract number2020-000799-39

Ctis2023-504991-31-00

NCT IDNCT04464564

Timeline

Milestones

Study first posted2020-07-09actual

Study start2020-09-11actual

Primary completion2024-06-28actual

Study completion2024-06-28actual

Last update posted2025-05-30actual

Results first posted2025-05-30actual

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

•Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria

•Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment

•Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions

•Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.

•Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff

•Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant

Exclusion criteria

•Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)

•Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)

•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 [except skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)

•Participants with myasthenia gravis

Endpoints (6)

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

Safety / tolerability / PK

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Change From the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

Time frame:Week 1 to Week 10

event count, event

Primary/registry result

Change From the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

Time frame:Week 1 to Week 10

event count, event

Secondary/protocol endpoint

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

Time frame:Week 1 to Week 10

descriptive

Secondary/registry result

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

Time frame:Week 1 to Week 10

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE

Time frame:From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16)

event count, event

Primary/registry result

Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE

Time frame:From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboTEAEsn=76 Participants	25	-
Serious TEAEsn=76 Participants	4	-
AVP-786-18TEAEsn=83 Participants	38	-
Serious TEAEsn=83 Participants	5	-
AVP-786-42.63TEAEsn=77 Participants	34	-
Serious TEAEsn=77 Participants	5	-

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.