Adults 50 to 90, any sex, with Agitation in Patients With Dementia of the Alzheimer's Type. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEPrimary· 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 d
TEAEs
Group
Value
95% CI
Placebo
25
AVP-786-18
38
AVP-786-42.63
34
Serious TEAEs
Group
Value
95% CI
Placebo
4
AVP-786-18
5
AVP-786-42.63
5
Adverse events — posted to ClinicalTrials.gov
Time frame: From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 4/76 (5%)
Deaths: 1/76
AVP-786-18
Serious: 5/83 (6%)
Deaths: 0/83
AVP-786-42.63
Serious: 5/77 (6%)
Deaths: 1/77
Serious adverse events (19 terms)
Reaction
System
Placebo
AVP-786-18
AVP-786-42.63
Acute myocardial infarction
Cardiac disorders
—
—
—
Oesophageal achalasia
Gastrointestinal disorders
—
—
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Death
General disorders
—
—
—
COVID-19
Infections and infestations
—
—
—
Pneumonia
Infections and infestations
—
—
—
Upper respiratory tract infection
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Accidental exposure to product
Injury, poisoning and procedural complications
—
—
—
Cervical vertebral fracture
Injury, poisoning and procedural complications
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
Hand fracture
Injury, poisoning and procedural complications
—
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
—
Radius fracture
Injury, poisoning and procedural complications
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
Dizziness
Nervous system disorders
—
—
—
Psychomotor hyperactivity
Nervous system disorders
—
—
—
Delirium
Psychiatric disorders
—
—
—
Other adverse events (115 terms — click to expand)
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04408755 — Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia
· Phase 3
· terminated
NCT03896945 — Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
· Phase 2, PHASE3
· terminated
NCT03420222 — Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
· Phase 2
· terminated
NCT03393520 — Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulf
· Phase 3
· completed
NCT02446132 — Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementi
· Phase 3
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 30 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04464564.