Trial · NCT05228821
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in CBF | Baseline to Week 24 | Change from Baseline in CBF through Week 24 measured by magnetic resonance imaging (MRI) using pseudo-continuous arterial spin labeling (pCASL). |
| Secondary | Change in executive functioning. | Baseline to Week 24 | Change from Baseline through Week 24 in the executive cognitive abilities composite score (using Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Test) as assessed by the National Institutes of Health Toolbox Cognition Module. |
| Secondary | Change in processing speed | Baseline to Week 24 | Change from Baseline through Week 24 in processing speed (using Pattern Comparison Test) as assessed by the NIH Toolbox Cognition Module |
| Secondary | Change in nonexecutive functioning | Baseline to Week 24 | Change from Baseline through Week 24 in nonexecutive cognitive abilities composite score (using Picture Vocabulary Test, Oral Reading Recognition Test, and Picture Sequence Memory Test) as assessed by the NIH Toolbox Cognition Module. |
| Other | Change in Hb and hemolysis over time | Baseline to week 24 | Change and percent change from Baseline through Week 24 in hemolysis measures, including unconjugated bilirubin, absolute reticulocyte, % reticulocytes, and lactate dehydrogenase (LDH). |
| Other | Change in cerebral dynamics | Baseline to week 24 | Change from baseline through Week 24 in cerebral blood flow, oxygen extraction, and oxygen metabolism as measured by diffusion correlation spectroscopy (DCS)/frequency domain near infrared spectroscopy (FDNIRS) (if available) Correlation of cerebral hemodynamics measured by DCS/FDNIRS (if available) and cerebral hemodynamics measured by MRI. |
| Other | Change in global OEF as measured using T2-Relaxation-Under-Spin-Tagging (TRUST) | Baseline to week 24 | Change from Baseline to Week 24 in global OEF as measured using TRUST (if available)). |
| Other | Change in regional CBF within the grey matter | Baseline to Week 24 | Change from Baseline through Week 24 in regional CBF within the grey matter. |
| Other | Change in regional CBF within the white matter | Baseline to Week 24 | Change in HRQOL scores using: Change from Baseline through Week 24 in regional CBF within the white matter |
| Other | Change in regional OEF as measured using ASE (If available) | Baseline to week 24 | Change from Baseline to Week 24 in regional OEF as measured using ASE (if available) |
| Other | Correlation between changes from Baseline in CBF (MRI and DCS/FDNIRS) | Baseline to Week 24 | Correlation between changes from Baseline in CBF (MRI and DCS/FDNIRS) and changes from Baseline in Hb levels |
| Other | Correlation of changes from Baseline in OEF (MRI and DCS/FDNIRS) | Baseline to Week 24 | Correlation of changes from Baseline in OEF (MRI and DCS/FDNIRS) and changes from Baseline in Hb levels |
| Other | Correlation of change from Baseline in Hb | Baseline to Week 24 | Correlation of change from Baseline in Hb and change from Baseline in executive abilities composite score |
| Other | Change in HRQOL scores | Baseline to Week 24 | Change in HRQOL scores using Patient Global Impression of Severity (PGI-S) |
| Other | Change in HRQOL scores using Clinician Global Impression of Severity. | Baseline to Week 24 | Change in HRQOL scores using Clinician Global Impression of Severity (CGI-S) |
| Other | Incidence and severity of treatment-emergent AEs (TEAEs) | Baseline to Week 24 | Incidence and severity of treatment-emergent AEs (TEAEs) baseline through week 24. |
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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