Trial · NCT06947941
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score | Up to approximately Week 14 | |
| Secondary | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score | Up to approximately Week 14 | |
| Secondary | Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score | Up to approximately Week 14 | NPI-C Core Score includes assessment for hallucinations, delusions, agitation, and aggression domains |
| Secondary | Change From Baseline in NPI-C: Agitation Score | Up to approximately Week 14 | |
| Secondary | Change From Baseline in NPI-C Core Score: Caregiver Distress Scale | Up to approximately Week 14 | NPI-C Core Score: Caregiver Distress Scale includes assessment for hallucinations, delusions, agitation, and aggression domains |
| Secondary | Responder Rate | Up to approximately Week 14 | Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40%. |
| Secondary | Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score | Up to approximately Week 14 | |
| Secondary | Change From Baseline in CMAI Total Score | Up to approximately Week 14 | |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to approximately Week 14 | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to approximately Week 14 | |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Up to approximately Week 14 | |
| Secondary | Number of Participants With TEAEs Leading to Discontinuation | Up to approximately Week 14 | |
| Secondary | Number of Participants With Spontaneously Reported Procholinergic Symptoms | Up to approximately Week 14 | Procholinergic symptoms include nausea, vomiting, and diarrhea. |
| Secondary | Number of Participants With Spontaneously Reported Anticholinergic Symptoms | Up to approximately Week 14 | Anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision. |
| Secondary | Number of Participants With AEs of Special Interest (AESIs) | Up to approximately Week 14 | AESIs such as symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes will be evaluated. |
| Secondary | Barnes Akathisia Rating Scale (BARS) Score | Up to approximately Week 14 | |
| Secondary | Abnormal Involuntary Movement Scale (AIMS) Score | Up to approximately Week 14 | |
| Secondary | International Prostate Symptom Score (IPSS) | Up to approximately Week 14 | This will be measured in males only. |
| Secondary | Body Weight | Up to approximately Week 14 | |
| Secondary | Body Mass Index (BMI) | Up to approximately Week 14 |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06947941/registered