Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

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List	Outcome	Time frame	Description
Primary	Change from baseline in physical examination	Subjects will be followed up to 14 days post-dose	Physical examination
Primary	Rates of adverse events and serious adverse events	Subjects will be followed up to 14 days post-dose	Adverse events and serious adverse events
Primary	Rates of early termination due to adverse events	Subjects will be followed up to 14 days post-dose	Early termination due to adverse events
Primary	Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results	Subjects will be followed up to 14 days post-dose	Vital signs, clinical laboratory values, and electrocardiogram results
Primary	Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)	Subjects will be followed up to 14 days post-dose	Neuropsychiatric Inventory (NPI-12) - NPI-12 assesses 12 behavioral domains common in dementia. Higher scores indicate more severe illness.
Primary	Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS)	Subjects will be followed up to 14 days post-dose	Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely
Primary	Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4	Subjects will be followed up to 14 days post-dose	Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4 includes 6 items assessing motor complications, higher scores indicate more serious illness.
Primary	Change in total score of the Sheehan Suicidality Tracking Scale (S-STS)	Subjects will be followed up to 14 days post-dose	Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely
Secondary	Change from baseline in the One Back test	Week 12	The One Back test is a measure of working memory
Secondary	Change from baseline in the Two Back test	Week 12	The Two Back test is a measure of working memory
Secondary	Change from baseline in the Groton Maze Learning Test	Week 12	The Groton Maze Learning test is a measure of problem solving and reasoning
Secondary	Change from baseline in the Identification Test	Week 12	The Identification test is a measure of visual attention
Secondary	Change from baseline in the International Shopping List Test	Week 12	The International Shopping List test is a measure of verbal learning
Secondary	Change from baseline on Continuous Paired Associate Learning Test	Week 12	The Continuous Paired Associate Learning test is a measure of visual associate memory

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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