Back to resultsVI-1121 for the Treatment Alzheimer's Disease (AD-201)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VI-1121
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring donepezil, VI-1121
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo/VI-1121
VI-1121/Placebo
Arm Description
Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.
Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period.
Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period.
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
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
Full Information
NCT ID
NCT01428362
First Posted
August 31, 2011
Last Updated
November 15, 2013
Sponsor
VIVUS LLC
Collaborators
Medpace, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01428362
Brief Title
VI-1121 for the Treatment Alzheimer's Disease
Acronym
AD-201
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVUS LLC
Collaborators
Medpace, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
donepezil, VI-1121
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo/VI-1121
Arm Type
Experimental
Arm Description
Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.
Arm Title
VI-1121/Placebo
Arm Type
Experimental
Arm Description
Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.
Intervention Type
Drug
Intervention Name(s)
VI-1121
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VI-1121 for the Treatment Alzheimer's Disease
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