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Trial · NCT05607615

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySafety assessments to include incidence of Adverse Events and Serious Adverse Eventsup to 24 weeksIncidence of AEs, SAEs, incidence of abnormal laboratory test results, abnormal ECGs, abnormal physical exams, abnormal vital signs and abnormal hearing assessments assessments
SecondaryMean change in total ADAS-Cog-14 score from BaselineWeek 12 and 24Memory, Language, and Executive Function
SecondaryChange in CDR-SB from BaselineWeeks 12 and 24Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care
SecondaryChange in MMSE-2:SV total score from BaselineWeeks 12 and 24Orientation, Attention, Memory, Language, and Visual-Spatial Skills
SecondaryChange in ADCS-CGIC from BaselineWeeks 12 and 24Cognitive, Behavior, and Social and Daily Functioning
SecondaryChange in ADCS-ADL from BaselineWeeks 12 and 24Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items
OtherChange in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on ADAS-Cog-14At week 12 and week 24Memory, Language, and Executive Function
OtherChange in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SBAt week 12 and week 24Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care
OtherChange in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on MMSE-2:SVAt week 12 and week 24Orientation, Attention, Memory, Language, and Visual-Spatial Skills
OtherPeak Plasma Concentration (Cmax)Weeks 4, 8, 12, and 24Maximum concentration, determined directly from individual concentration-time data
OtherTime to the Maximum concentration (Tmax)Weeks 4, 8, 12, and 24Time of the maximum concentration, determined directly from individual concentration-time data
OtherArea under the plasma concentration versus time curve (AUC)Weeks 4, 8, 12, and 24Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration

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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