Trial · NCT07642518
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 | Montreal Cognitive Assessment Scale (MoCA) score | Baseline, and Week 24 | The MoCA is a comprehensive endpoint focusing on the cognitive domain. It integrates multidimensional assessments of core cognitive functions (including subscale scores for visuospatial/executive function, naming, attention, language, abstraction, delayed recall, and orientation), yielding a total score range of 0-30.The calculation formula is:MoCA Score = Subscale Scores+ Educational Correction(Note: If the participant's formal education is ≤12 years, 1 point is added to the sum of the subscale scores, with the maximum total score capped at 30).Lower MoCA scores indicate more severe global cognitive impairment in the participant. |
| Secondary | Change in score of Mini-Mental State Examination (MMSE) | from baseline to week 24 of treatment | The MMSE contains a total of 30 items that assess orientation, registration, attention and calculation, recall, and language, with a score range from 0 to 30. Generally, a higher MMSE score reflects a better cognitive function. |
| Secondary | Changes in total score of RBANS | from baseline to week 24 of treatment | The RBANS (Chinese version) is a brief neuropsychological screening battery with established test-retest reliability and age-appropriate normative data, which consists of 12 task tests assessing 5 cognitive domains, namely immediate memory, visuospatial/ constructional, language, attention and delayed memory, with a score range from 40 to 160. A higher RBANS score reflects a better global cognitive function. |
| Secondary | Change in the RBANS index score of immediate memory | from baseline to week 24 of treatment | The RBANS (Chinese version) is a brief neuropsychological screening battery with established test-retest reliability and age-appropriate normative data. The RBANS includes 12 sub-tests that generate five age-adjusted index scores and a total score. The five indices include immediate memory (consisting of list learning and story memory tests), visuospatial/constructional domain (consisting of figure copying and line orientation tests), language (consisting of picture naming and semantic fluency tests), attention (consisting of digit span and coding tests) and delayed memory (consisting of list recall, story recall, figure recall and list recognition tests). Generally, a higher index score reflects a better cognitive subdomain function. |
| Secondary | Change in the RBANS index score of visuospatial/constructional | from baseline to week 24 of treatment | Measurements and instruments are the same as the RBANS index score of immediate memory. |
| Secondary | Change in the RBANS index score of language | from baseline to week 24 of treatment | Measurements and instruments are the same as the RBANS index score of immediate memory. |
| Secondary | Change in the RBANS index score of attention | from baseline to week 24 of treatment | Measurements and instruments are the same as the RBANS index score of immediate memory. |
| Secondary | Change in the RBANS index score of delayed memory | from baseline to week 24 of treatment | Measurements and instruments are the same as the RBANS index score of immediate memory. |
| Secondary | Change in aggregate time to test completion for Trail Making Test (TMT) | from baseline to week 24 of treatment | The TMT is a validated timed measure of processing speed, which consists of part A and part B (TMT-A and TMT-B). The time limits for performing the TMT-A and TMT-B are 180 and 300 seconds, respectively. Processing speed is estimated by the aggregate time in seconds to complete TMT-A and TMT-B such that less time indicate faster processing speed. |
| Secondary | Change in aggregate time to test completion for Victoria Stroop Color-Word Test | from baseline to week 24 of treatment | The Victoria Stroop Color-Word Test is a well-known measure of executive function. There are three indices including Stroop-dot, Stroop-word and Stroop-color word in the test. The color task consists of colored dots; the word task comprises ordinary words that are unrelated to the meaning of color; the color-word task consists of words written in color that indicate the meaning of the color, but the color of these words differs from the meaning of the word itself. The participants were asked to quickly read the color of the dots or Chinese words on the cards. The sum of consuming time taken to read the three cards is used as an index of executive function performance. Less time indicates better executive function. |
| Secondary | Change in Total Brain Volume | from baseline to week 24 of treatment | The change in total brain volume evaluated by structural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group. |
| Secondary | Change in Total White Matter Volume | from Baseline to Week 24 of treatment | The change in total white matter volume evaluated by structural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group. |
| Secondary | Change in Total Gray Matter Volume | from Baseline to Week 24 of treatment | The change in total gray matter volume evaluated by structural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group. |
| Secondary | Change in Total White Matter Lesion Volume | from Baseline to Week 24 of treatment | The change in total white matter lesion volume evaluated by sturctural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group. |
| Secondary | Change in Cortical Gray Matter Lobar Volumes | from Baseline to Week 24 of treatment | The change in cortical gray matter lobar volumes evaluated by sturctural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group. |
| Secondary | Change in Subcortical Nuclei Volumes | from Baseline to Week 24 of treatment | The change in subcortical nuclei volumes evaluated by stuctural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group. |
| Secondary | Change in Blood-Based Neurodegeneration Biomarkers | from Baseline to Week 24 of treatment | The change in blood-based neurodegeneration biomarkers (includingAmyloid-β (Aβ42/40 ratio), Phosphorylated tau (p-tau217), Glial fibrillary acidic protein (GFAP), and Neurofilament light chain (NfL), etc.）evaluated by Simoa from baseline to Week 76 will be compared between the treatment group and the placebo group. |
| Secondary | Change in Heart Rate Variability | from Baseline to Week 24 of treatment | Change in heart rate variability from baseline to Week 24 will be assessed using time-domain and/or frequency-domain heart rate variability analysis |
| Secondary | Change in Cardiovascular Autonomic Reflex Test Result | from Baseline to Week 24 of treatment | Change in cardiovascular autonomic reflex function from baseline to Week 24 will be assessed using standardized cardiovascular autonomic reflex testing |
| Secondary | Change in Glycated Haemoglobin (HbA1c) Levels | from Baseline to Week 24 of treatment | Change in HbA1c levels from baseline to weeks 24 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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