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NCT03594123 · ClinicalTrials.gov registry record · Phase 3
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
A Phase 3 study of Alzheimers Disease, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 259
- Enrollment target
- 1
- Study location
NCT03594123: Completed Phase 3 study of Alzheimers Disease, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03594123 is a Phase 3 study of Alzheimers Disease that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 259 participants, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594123, a Phase 3 study of Alzheimers Disease, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 259 participants
- Enrollment target
- 1
- Study location
Study Summary
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with an onset date on or after the first dose of brexpiprazole. They are all adverse events that started after start of brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death,
Conditions Studied
Interventions
- DRUG Brexpiprazole
Study Locations (1)
Florida
- For additional information regarding sites, contact 844-687-8522 - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2022-09-19 |
| Phase | Phase 3 |
What the finished NCT03594123 record still lists
NCT03594123 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT03594123 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03594123 about?
NCT03594123 is a clinical study titled "A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type". Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).
What is the current status of trial NCT03594123?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 259 participants. The study started on 2018-10-11. Estimated completion is 2022-09-19.
What conditions does trial NCT03594123 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT03594123?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03594123?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03594123 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03594123's enrollment target sits among peer trials
259 47th of 147 higher than 101 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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