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Trial · NCT04437511

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)Baseline, Week 76All randomized participants with a baseline and at least one postbaseline iADRS data point.score on a scaleLEAST_SQUARES_MEAN
PRIMARYChange From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)Baseline, Week 76All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline iADRS data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)Baseline, Week 76All randomized participants with a baseline and at least one postbaseline MMSE data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)Baseline, Week 76All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline MMSE data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)Baseline, Week 76All randomized participants with a baseline and at least one postbaseline ADAS-Cog13 data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)Baseline, Week 76All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline ADAS-Cog13 data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)Baseline, Week 76All randomized participants with a baseline and at least one postbaseline CDR-SB data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)Baseline, Week 76All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline CDR-SB data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)Baseline, Week 76All randomized participants with a baseline and at least one postbaseline ADCS-iADL data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)Baseline, Week 76All randomized participants with a baseline Intermediate Tau level and with baseline and at least one postbaseline ADCS-iADL data point.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) ScanBaseline, Week 76All randomized participants with a baseline and at least one postbaseline amyloid PET scan data point.centiloidsLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET ScanBaseline, Week 76All randomized participants with a baseline and post-baseline tau PET scan.standardized uptake value ratio (SUVR)LEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)Baseline, Week 76All randomized participants with a baseline and at least one postbaseline vMRI data point.cubic centimeter (cm^3)LEAST_SQUARES_MEAN
SECONDARYPharmacokinetics (PK): Average Serum Concentration at Steady State of DonanemabWeek 16 to week 20All randomized participants who received at least one dose of study drug and had evaluable PK data.micrograms per milliliter (μg/mL)GEOMETRIC_MEAN
SECONDARYNumber or Participants With Anti-Donanemab AntibodiesBaseline through Week 76All randomized participants who received at least one dose of study drug and had evaluable anti-drug antibody measurement.ParticipantsCOUNT_OF_PARTICIPANTS

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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