Trial · NCT01739348
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | [Part I (Base Study)] Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded. | Score on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | [Part I (Base Study)] Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded. | Score on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | [Part II (Extension Study)] Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score | Baseline and week 104 | All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population), having an ADAS-Cog observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded. | Score on a Scale | MEAN |
| PRIMARY | [Part II (Extension Study)] Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score | Baseline and week 104 | All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population), having an ADCS-ADL observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded. | Score on a Scale | MEAN |
| PRIMARY | [Part I (Base Study)] Number of Participants Who Experienced an Adverse Event | Up to week 80 (up to 2 weeks following cessation of study treatment in Part I) | Includes all randomized participants in Part I receiving ≥1 dose of trial treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | [Part II (Extension Study)] Number of Participants Who Experienced an Adverse Event | From week 78 (end of treatment in Part I) up to week 262 of Part II | Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect AEs occurring in Part II only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | [Part I (Base Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event | Up to week 78 | Includes all randomized participants in Part I receiving ≥1 dose of trial treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | [Part II (Extension Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event | From week 78 (end of treatment in Part I) up to week 260 of Part II | Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect treatment discontinuations occurring in Part II only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | [Part I (Base Study)] Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window CDR-SB observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | [Part I (Base Study)] Percent Change From Baseline in Total Hippocampal Volume (THV) | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window THV observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | [Part I (Base Study)] Fold Change From Baseline in Cerebrospinal Fluid (CSF) Total Tau | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window CSF Total Tau observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded. | Fold Change | LEAST_SQUARES_MEAN |
| SECONDARY | [Part I (Base Study)] Change From Baseline in Cortical Amyloid Load Assessed by [18F]Flutemetamol PET Standard Uptake Value Ratio (SUVR) | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat did not receive SUVR testing and were excluded. | SUVR | LEAST_SQUARES_MEAN |
| SECONDARY | [Part I (Base Study)] Percentage of Participants Achieving Responder Status | Week 78 | All randomized participants in Part I receiving ≥1 dose of trial treatment. Per protocol, the first 200 participants enrolled prior to IA (across all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded from analysis. | Percentage of Participants | NUMBER |
| SECONDARY | [Part I (Base Study)] Change From Baseline in Neuropsychiatric Inventory (NPI) Score | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | [Part I (Base Study)] Change From Baseline in Mini-Mental State Examination (MMSE) Score | Baseline and week 78 | All randomized participants with a baseline and ≥1 within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded. | Score on a Scale | LEAST_SQUARES_MEAN |
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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GET https://conductscience.org/api/trials/v1/NCT01739348/outcomes