A Phase 2 interventional study of VI-1121 and Placebo in Alzheimer's Disease, sponsored by VIVUS LLC. Completed at 11 sites in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-12-11.
Sponsored by VIVUS LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 61 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →VIVUS LLC is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.
Drug: VI-1121 · Drug: Placebo
Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.
Drug: VI-1121 · Drug: Placebo
The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period.
Time frame: 12 weeks
The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period.
Time frame: 12 weeks
Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period.
Time frame: 12 Weeks
Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period
Time frame: 12 Weeks
Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to Weeks 4, 8, and 12 of each treatment period
Time frame: 4, 8, and 12 Weeks
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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VIVUS LLC