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Trial · NCT05564169

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryAbsolute change from baseline in iADRS score at week 2424 weeks
The iADRS is a linear combination of its two components: the ADAS-Cog11 and the ADCS-iADL. The iADRS is calculated as follows: iADRS = ADCS-iADL + (70 - ADAS-Cog11). Lower scores on the iADRS indicate greater impairment; iADRS scores range from 0 to 129.
SecondaryAbsolute change from baseline in Mini-Mental State Examination (MMSE) at week 2424 weeksMini-Mental State Examination (MMSE) (scores from 0 to 30, with lower scores indicating poorer cognitive performance)
SecondaryAbsolute change from baseline in ADAS-Cog11 score at week 2424 weeksThe global score, which is the sum of the 11 items, ranges from 0 to 70, with higher scores indicating greater cognitive impairment.
SecondaryAbsolute change from baseline in ADCS-ADL score48 weeksAlzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL) (scores from 0 to 78, with lower scores indicating worse function)
SecondaryClinical Responder rate24 weeks
Clinical response defined as decrease from baseline at week 24 in ADAS-cog of ≥4, without deterioration in ADCS-ADL (ADCS-ADL change ≥ 0 between baseline and timepoint) or worsening in the CIBIC-plus scale (response CIBIC in 1-3\] or no change \[CIBIC in 4\]).
SecondaryCIBIC-plus24 weeks
Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus), a seven-point categorical rating scale ranging from 1 (marked improved) to 7 (markedly worse) compared with baseline.
SecondaryAbsolute change from baseline in CDR24 weeksClinical Dementia Rating (CDR), scores from 0 to 18, with higher scores indicating worse dementia
SecondaryTime to severe dementia (MMSE<10)24 weeksMini-Mental State Examination (MMSE) (scores from 0 to 30, with lower scores indicating poorer cognitive performance)
SecondaryAbsolute change from baseline in ADAS-Cog11 score at week 4848 weeksThe global score, which is the sum of the 11 items, ranges from 0 to 70, with higher scores indicating greater cognitive impairment.
SecondaryAbsolute change from baseline in ADCS-ADL score at week 2424 weeksAlzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL) (scores from 0 to 78, with lower scores indicating worse function)
SecondaryAbsolute change from baseline in Neuropsychiatric Inventory (NPI) at week 2424 weeksTotal NPI-12 score ranges from 0 to 144 (higher = more severe symptoms)

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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