Trial · NCT04804241
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score | Baseline, Week 26, Week 52 | ADAS-Cog 13 is a scale used to measure cognitive dysfunction in a number of neural domains. Total scores range from 0-70, with higher scores indicating greater cognitive impairment and a worse outcome. |
| Primary | Change from Baseline to Week 52 in levels of Cerebrospinal fluid (CSF) biomarkers: IL-1β, IL-6, TNF-α, MCP-1, and IL-10 | Baseline, Week 52 | A lumbar puncture will be done and CSF collected at baseline prior to initiating study treatment and at Week 52 at the end of study treatment |
| Primary | Change from Baseline to Week 52 in levels of serum biomarkers: IL-6, TNF-α, MCP-1, and IL-10 and high sensitivity C-Reactive protein | Baseline, Week 52 | Blood draws will be done and serum processed at baseline prior to initiating study treatment and at Week 52 at the end of study treatment |
| Secondary | Change from Screening in the Clinical Dementia Rating (CDR) sum of boxes score | Screening, Week 26, Week 52 | The CDR is a widely used clinical tool for grading the relative severity of dementia with scores that range from 0 (no impairment) to 3 (severe impairment). A higher score indicates greater cognitive impairment and a worse outcome. |
| Secondary | Change from Baseline in the Everyday Cognition (ECog) score | Baseline, Week 26, Week 52 | The ECog is a validated instrument used to assess cognitively mediated functional abilities in older adults. It is comprised of 39 items and a higher total score indicates greater cognitive impairment and a worse outcome. |
| Secondary | Change from Screening in Montreal Cognitive Assessment (MoCA) score | Screening, Week 26, Week 52 | The MoCA is a diagnostic tool used for detecting Mild Cognitive Impairment and early Alzheimer's disease. The scale goes from 0 to 30. A higher score indicates less cognitive impairment and a better outcome. |
| Secondary | Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) memory score | Baseline, Week 52 | The SENAS was devised to be a broad set of psychometrically matched measures with equivalent Spanish and English versions. The composites are z-scores, the more positive the score is, the less cognitive impairment and the better the outcome. |
| Secondary | Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) executive composite score | Baseline, Week 52 | The SENAS was devised to be a broad set of psychometrically matched measures with equivalent Spanish and English versions. The composites are z-scores, the more positive the score is, the less cognitive impairment and the better the outcome. |
| Secondary | Change from Baseline in Bushcke Cued Selective Reminding Task (CSRT) score | Baseline, Week 26, Week 52 | The CSRT is widely used to identify mild dementia and measure associative learning and memory. It involves a study phase where subjects identify pictured items in response to category cures. This is followed by a free recall period and then a cued recall period where category cues are presented to the subjects. The raw score for the CSRT is 0 to 48 (16 items with 3 recall trials). The combined scores when combining the Free plus Cued Recall trials is 0 to 96. The higher the score, the less cognitive impairment and the better the outcome. |
| Secondary | Change from Baseline in Trails B score | Baseline, Week 26, Week 52 | The Trails B is a well-established measure of executive function in which subjects must serially connect alternating numbers and letters. It is scored based on accuracy and time to completion. A longer time to complete indicates greater cognitive impairment and a worse outcome. |
| Secondary | Change from Baseline in Verbal fluency (semantic) score | Baseline, Week 26, Week 52 | Controlled Oral Word Association Test (COWAT) is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter (e.g. Animals, Fruits, Vegetables, letter 'F', 'A', 'S'). The more words correctly stated by the participant for a particular category in a 1-minute time period indicates less cognitive impairment and a better outcome. |
| Secondary | Change from Baseline in Verbal fluency (letter) score | Baseline, Week 26, Week 52 | Controlled Oral Word Association Test (COWAT) is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter (e.g. Animals, Fruits, Vegetables, letter 'F', 'A', 'S'). The more words correctly stated by the participant for a specific letter in a 1-minute time period, indicates less cognitive impairment and a better outcome. |
| Secondary | Change from Baseline to Week 52 in Brain MRI measures of total grey matter. | Baseline, Week 52 | Volumetric MRIs will be done at baseline and Week 52. |
| Secondary | Change from Baseline to Week 52 in Brain MRI measures of total brain volume. | Baseline, Week 52 | Volumetric MRIs will be done at baseline and Week 52. |
| Secondary | Change from Baseline to Week 52 in Brain MRI measures of white matter hyperintensities. | Baseline, Week 52 | Volumetric MRIs will be done at baseline and Week 52. |
| Secondary | Change from Baseline to Week 52 in total grey matter florbetaben binding on amyloid Positron Emission Tomography (PET) | Baseline, Week 52 | Amyloid PETs will be done at baseline and Week 52. |
| Secondary | Change from Baseline in Cognitive Event Related Potential (ERP) measures of P600 word repetition. | Baseline, Week 26, Week 52 | Cognitive ERPs will be done at Baseline, Week 26 and Week 52 |
| Secondary | Change from Baseline in Cognitive Event Related Potential (ERP) measures of alpha suppression effect. | Baseline, Week 26, Week 52 | Cognitive ERPs will be done at Baseline, Week 26 and Week 52 |
| Secondary | Change from Baseline in Cognitive Event Related Potential (ERP) measures of anti-coupling between early theta and late alpha/beta activity. | Baseline, Week 26, Week 52 | Cognitive ERPs will be done at Baseline, Week 26 and Week 52 |
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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