Trial · NCT03467152
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| PRIMARY | Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment | Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPI-4 Subscore at Week 12 | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPI-10 Subscore at Week 12 | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPI-D (Caregiver Distress) Total Score at Week 12 | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | From first dose of study drug up to Week 16 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Orthostatic Hypotension | Week 2, Week 4, Week 6, Week 9 and Week 12 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Orthostatic Tachycardia | From first dose of study drug up to Week 16 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Markedly Abnormal Laboratory Values | From first dose of study drug up to Week 16 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. Here overall number analyzed N are the participants who were evaluable for the outcome measure. Number analyzed n are the participants who were evaluable for the outcome measure for given categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | From first dose of study drug up to Week 16 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. Here overall number analyzed N are the participants who were evaluable for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS) | From first dose of study drug up to Week 16 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. Here overall number analyzed N are the participants who were evaluable for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III) | Baseline up to Week 16 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
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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GET https://conductscience.org/api/trials/v1/NCT03467152/outcomes