Trial · NCT00566501
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | From the enrollment of the study up to 30 days after last dose of the study drug (up to 2 years 3 months) | The safety population included all participants who received at least one dose of the study medication during the open-label treatment period and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With at Least 1 Treatment-Emergent Abnormal Laboratory Values (TEAVs): Hematology | From the first dose of study drug up to 2 years 3 months | The safety population included all participants who received at least one dose of the study medication during the open-label treatment period and had at least one post-baseline safety assessment. Here 'N' (overall number analyzed) are the participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 TEAVs for Selected Parameters: Clinical Chemistry | From the first dose of study drug up to 2 years 3 months | The safety population included all participants who received at least one dose of the study medication during the open-label treatment period and had at least one post-baseline safety assessment. Here 'N' (overall number analyzed) are the participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Severe Impairment Battery (SIB) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | The Intent-to-treat (ITT) population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mini-Mental State Examination (MMSE) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Severe Scale (ADCS-ADL) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Quality of Life-Alzheimer's Disease (Qol-AD) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Screen for Caregiver Objective Burden (SCB) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Screen for Caregiver Subjective Burden (SCB) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment Outcome Scale (TOS) Score | At Months 6 and 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Goal Attainment Scaling (GAtS) Score Total Score | At Months 6 and 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00566501/outcomes