Trial · NCT07912710
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mild cognitive impairment (MCI) | Baseline and approximately annual follow-up assessments (up to 50 years) | MCI is diagnosed according to the 2004 International Working Group (IWG) broad clinical criteria. Diagnostic status is assessed at baseline and during follow-up. |
| Primary | Dementia | Baseline and approximately annual follow-up assessments (up to 50 years) | Dementia is diagnosed according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria for all-cause dementia. Diagnostic status is assessed at baseline and during follow-up. |
| Primary | Mild cognitive impairment due to Alzheimer's disease (MCI due to AD) | Baseline and approximately annual follow-up assessments (up to 50 years) | MCI due to AD is diagnosed according to the 2011 NIA-AA clinical criteria, based on the presence of MCI and clinical evidence consistent with AD etiology. Diagnostic status is assessed at baseline and during follow-up. |
| Primary | Dementia due to Alzheimer's disease (AD dementia) | Baseline and approximately annual follow-up assessments (up to 50 years) | AD dementia is diagnosed according to the 2011 NIA-AA clinical criteria for probable or possible Alzheimer's disease dementia among participants meeting the criteria for all-cause dementia. Diagnostic status is assessed at baseline and during follow-up. |
| Primary | Mini-Mental State Examination (MMSE) total score | Baseline and approximately annual follow-up assessments (up to 50 years) | Global cognitive function is assessed using the MMSE (range: 0-30; higher scores indicate better cognition). Longitudinal changes are used to evaluate the rate of cognitive decline. |
| Primary | Montreal Cognitive Assessment (MoCA) total score | Baseline and approximately annual follow-up assessments (up to 50 years) | Global cognitive function is assessed using the MoCA (range: 0-30; higher scores indicate better cognition). Longitudinal changes are used to evaluate the rate of cognitive decline. |
| Primary | Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score | Baseline and approximately annual follow-up assessments (up to 50 years) | Cognitive and functional impairment is assessed using CDR-SB (range: 0-18; higher scores indicate greater impairment). Longitudinal changes are used to evaluate the rate of decline. |
| Secondary | Auditory Verbal Learning Test (AVLT) learning score | Baseline and approximately annual follow-up assessments (up to 50 years) | Verbal learning is assessed using the sum of correctly recalled words across AVLT learning trials N1-N3. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Auditory Verbal Learning Test (AVLT) short-delay recall score | Baseline and approximately annual follow-up assessments (up to 50 years) | Short-delay memory is assessed using the number of correctly recalled words in AVLT N4. Higher scores indicate better memory performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Auditory Verbal Learning Test (AVLT) long-delay recall score | Baseline and approximately annual follow-up assessments (up to 50 years) | Long-delay memory is assessed using the number of correctly recalled words in AVLT N5. Higher scores indicate better memory performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Forward Digit Span Test score | Baseline and approximately annual follow-up assessments (up to 50 years) | Attention and immediate memory are assessed using the maximum number of digits correctly recalled in forward order. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Backward Digit Span Test score | Baseline and approximately annual follow-up assessments (up to 50 years) | Working memory is assessed using the maximum number of digits correctly recalled in reverse order. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Trail Making Test Part A (TMT-A) completion time | Baseline and approximately annual follow-up assessments (up to 50 years) | Attention and processing speed are assessed using TMT-A completion time in seconds. Longer times indicate poorer performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Trail Making Test Part B (TMT-B) completion time | Baseline and approximately annual follow-up assessments (up to 50 years) | Executive function is assessed using TMT-B completion time in seconds. Longer times indicate poorer performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Clock Drawing Test (CDT) total score | Baseline and approximately annual follow-up assessments (up to 50 years) | Visuospatial function is assessed using the CDT (range: 0-30; higher scores indicate better performance). Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Verbal Fluency Test (VFT) total score | Baseline and approximately annual follow-up assessments (up to 50 years) | Verbal fluency is assessed using the total number of valid words generated across the administered categories. Higher scores indicate better performance. Longitudinal changes are evaluated using repeated assessments. |
| Secondary | Plasma amyloid-β 1-42 (Aβ1-42) concentration | Baseline and follow-up assessments (up to 50 years) | Plasma Aβ1-42 concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available. |
| Secondary | Plasma amyloid-β 1-40 (Aβ1-40) concentration | Baseline and follow-up assessments (up to 50 years) | Plasma Aβ1-40 concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available. |
| Secondary | Plasma amyloid-β 1-42/1-40 ratio (Aβ1-42/Aβ1-40) | Baseline and follow-up assessments (up to 50 years) | The plasma Aβ1-42/Aβ1-40 ratio is calculated from measured plasma concentrations (unitless). Longitudinal changes are evaluated when repeated measurements are available. |
| Secondary | Plasma phosphorylated tau 181 (p-tau181) concentration | Baseline and follow-up assessments (up to 50 years) | Plasma p-tau181 concentration is measured in participants with available plasma samples. Longitudinal changes are evaluated when repeated measurements are available. |
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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