Trial · NCT04251585
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Measured by Count of Safety Events | 3 weeks | Composite safety event - this is a count of either a reduction of fasting glucose to \<70 mg/dL or an unintended reduction of weight \>5%. A larger composite event count indicates a less safe treatment. |
| Primary | Safety Measured by Fasting Glucose | baseline and 3 weeks | Pre-post change in fasting glucose (mg/dL). A larger decrease in fasting glucose indicates a less safe treatment. |
| Primary | Safety Measured by Body Weight | baseline and 3 weeks | Pre-post change in body weight (lbs). An unintended decrease in body weight indicates a less safe treatment. |
| Primary | Safety Measured by the Number of Serious Adverse Events (SAE) and Adverse Events (AE) | 3 weeks | Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. |
| Secondary | Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA) | 5 weeks | Pre-post difference. Total sum of scores. Range: 0-30. Higher score indicates less memory loss |
| Secondary | Cognitive Function Measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span | 3 weeks | Pre-post difference. Scaled score. Range: 1-19. Forward and backward. Lower score indicates more impairment. |
| Secondary | Cognitive Function Measured by the Trailmaking Test Part A Time | baseline and 3 weeks | Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired. |
| Secondary | Cognitive Function Measured by the Trailmaking Test Part B Time | baseline and 3 weeks | Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired. |
| Secondary | Cognitive Function Measured by the Trailmaking Test Parts A & B Errors | 3 weeks | Pre-post difference. Total number of errors. No range. More errors indicate more impairment. |
| Secondary | Cognitive Function Measured by the Judgement of Line Orientation | baseline and 3 weeks | Judgement of Line Orientation is an assessment of visuospatial ability. A Z-score of 0 represents the population mean. Pre-post difference. A positive difference indicates an improvement. |
| Secondary | Cognitive Function Measured by the Logical Memory Scaled Scores | baseline and 3 weeks | Pre-post difference. Scaled score. Range: 1-19. Logical memory immediate and delayed. Lower score indicates more impairment. |
| Secondary | Cognitive Function Measured by the Logical Memory, Recognition | baseline and 3 weeks | Pre-post difference in median category from baseline to 3 weeks on the Logical memory, recognition subscale. Scoring of this and all outcomes were based on best practices conveyed by study neuropsychologist during study design, and scoring approaches were chosen completely a priori. The recognition outcome of the LM test is derived from a series of conversions, as follows. First, the raw "process" score is converted to cumulative percentage (0-100). Because the cumulative percentage distribution is known to be skewed, best practice is to report scores as the following ordinal categorizations of cumulative percentages: \<1, 3-9, 10-16, 17-25, 26-50, 51-75, and \>75. To analyze them using simple statistics, these ordinal categories are converted to integer values (1-7), and the change in median ordinal category is presented along with 95% confidence intervals, generated by the Wilcoxon signed rank test with continuity correction. |
| Secondary | Cognitive Function Measured by the Hopkins Verbal Learning Test - Revised (HVLT) | baseline and 3 weeks | Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired. |
| Secondary | Cognitive Function Measured by the Visuospatial Memory Test - Revised (BVMT) | 3 weeks | Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired. |
| Secondary | Cognitive Function Measured by the Stroop Color Word Test (CWT) | baseline and 3 weeks | Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired. |
| Secondary | Cognitive Function Measured by Fluency | baseline and 3 weeks | Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired. |
| Secondary | Mood Measured by the Beck Depression Inventory - Second Edition | baseline and 3 weeks | Pre-post difference. Raw score. Range: 0-63. Higher score indicates more symptomatic. |
| Secondary | Apathy Measured by the Apathy Scale | baseline and 3 weeks | Pre-post difference. Raw score. Range: 0-42. Higher score indicates more symptomatic. |
| Secondary | Mood Measured by the Columbia Suicide Severity Rating (C-SSRS) | baseline and 3 weeks | Pre-post difference. Raw score. Range:1 or 0. 1 score - more symptomatic, 0 score - no symptoms. |
| Secondary | Motor Function as Measured by the United Parkinson's Disease Rating Scale (UPDRS-III) | baseline and 3 weeks | Pre-post difference. Raw score. Range: 0-72. Higher score indicates more symptomatic. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04251585/registered