VI-1121 for the Treatment Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: VI-1121; Drug: Placebo

• Registration Number: NCT01428362
• Lead Sponsor: VIVUS LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Disposition First Submitted: 2013-10-23
• Disposition First Submitted QC: 2013-10-23
• Status Verified: 2013-11
• Disposition First Posted: 2013-11-15
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• clinical diagnosis of Alzheimer's disease
• CT or MRI within 2 years prior to study
• stable dose of current Alzheimer's treatment for at least 3 months

Exclusion Criteria

• advanced, severe, progressive or unstable disease
• history of cerebrovascular disease or myocardial infarction within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo/VI-1121	Placebo	Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.
VI-1121/Placebo	VI-1121	Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.
VI-1121/Placebo	Placebo	Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.
Placebo/VI-1121	VI-1121	Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.

Primary Outcome Measures

Name	Time	Method
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.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period.	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.	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	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	4, 8, and 12 Weeks