A Phase 3 interventional study of Placebo and AVP-786 in Agitation in Patients With Dementia of the Alzheimer's Type, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 211 sites in 11 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.
Approximately 550 participants will be enrolled at approximately 90 centers worldwide.
Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
231 studies on the registry are indexed under Psychomotor Agitation; 28 are open to participants now.
This study's enrollment of 601 is above the median of 100 across 188 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 297 studies on the registry; 19 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
Compared within Psychomotor Agitation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Drug: Placebo
Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
Drug: AVP-786
Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
Drug: AVP-786
oral capsules
Drug pages: Deudextromethorphan · Quinidine
oral capsules
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Time frame: Baseline; Week 12
Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score
Time frame: Baseline; Week 12
Showing the first 100 of 211 sites across 11 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Data sharing details ↗ · clinical-trials.otsuka.com
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Nov 2023, 73 months.
Of 23 phase 3 interventional studies under Psychomotor Agitation, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 47. This study's 73 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Deudextromethorphan · Quinidine
Otsuka Pharmaceutical Development & Commercialization, Inc. →