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Trial · NCT05543681

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryAgitationBaseline to week sixChange in mean Cohen Mansfield Agitation Inventory (CMAI) score
SecondaryAcute AgitationBaseline to week twoChange in mean Cohen Mansfield Agitation Inventory (CMAI) score
OtherAgitation at week fourBaseline to week fourChange in mean Cohen Mansfield Agitation Inventory (CMAI) score
OtherParticipant overall wellbeingBaseline to weeks two and sixChange in the Clinical Global Impression Scale (CGI)
OtherParticipant executive functionsBaseline to week sixChange in Mini-Mental State Examination (MMSE2) score
OtherDepressionBaseline to weeks two, four, and sixChange in mean Cornell Scale for Depression in Dementia (CSDD) score
OtherNeuropsychiatric symptomsBaseline to weeks two, four, and sixChange in mean Neuropsychiatric Inventory (NPI-12) score
OtherParticipant quality of lifeBaseline to weeks two, four and sixChange in mean Quality of Life in Alzheimer's Disease (QOL-AD) score
OtherCaregiver burdenBaseline to weeks two and sixChange in mean Zarit Burden Interview (ZBI) score
OtherPsychotropic drugsBaseline to six weeksChange in type and dosage of psychotropic drugs
OtherCYP2C9 polymorphisms on agitationBaseline to weeks two, four and sixChange in mean Cohen Mansfield Agitation Inventory (CMAI) score for each type of metabolizer group (\*1/\*1, \*1/\*3, etc.)

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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