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Trial · NCT04390646

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryCognitionBaseline to end of treatment (Week 24)Montreal Cognitive Assessment (MoCA) total score ranges between 0 and 30 (cut-off set at 26 for the healthy population) Higher scores reflect better performance.
SecondaryDimensional change card sorting task (DCCS)baseline to end of treatment (Week 24)change in score of DCCS to assess executive functions
SecondaryPaired Associated Learning (PAL, part of the CANTAB battery)baseline to end of treatment (Week 24)change in score of PAL to assess learning
SecondaryToken testbaseline to end of treatment (Week 24)change in score of Token test to assess verbal comprehension
SecondaryCorsi block tapping taskbaseline to end of treatment (Week 24)change in score to assess visuospatial memory
SecondaryLitmus non-word-repetition testbaseline to end of treatment (Week 24)change in score of Litmus test to assess phonological abilities
SecondaryHealth-related quality of life SF-12baseline to end of treatment (Week 24)
The health-related quality of life (HRQoL) can be used to measure the effects of healthcare interventions and provide quality-improvement outcomes. The Short Form-12 (SF-12) Health Survey is widely used in measuring HRQoL. SF-12 is a reliable, valid measure in a variety of population groups; it is an equivalent substitute for the SF-36v2 for the summary scales. The response to each of the 12 items is weighted separately by the physical and mental component summary (PCS and MCS) regression coefficients and then calculated to give the SF-12 PCS and MCS scores.
SecondaryAdaptive behavior (Vineland II) - caregiver questionnairebaseline to end of treatment (Week 24)change in score of Vineland II (normed assessment tool that assesses adaptive behavior across the areas of communication, activities of daily living, and socialization).
SecondaryGlycemiabaseline to end of treatment (Week 24)Glucose concentration (mmol/L) is a metabolic parameter.
SecondaryInsulinemiabaseline to end of treatment (Week 24)Insulin concentration (nmol/L) is a metabolic parameter.
SecondaryTotal cholesterolbaseline to end of treatment (Week 24)Total cholesterol (mmol/L) is a metabolic parameter.
SecondaryHigh density lipoprotein (HDL)-cholesterolbaseline to end of treatment (Week 24)HDL-cholesterol (mmol/L) is a metabolic parameter.
SecondaryLow density lipoprotein (LDL)-cholesterolbaseline to end of treatment (Week 24)LDL-cholesterol (mmol/L) is a metabolic parameter.
SecondaryTriglyceridesbaseline to end of treatment (Week 24)Triglycerides (mmol/L) is a metabolic parameter.

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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