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VI-1121 for the Treatment Alzheimer's Disease (AD-201)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01428362
First Posted: September 5, 2011
Last Update Posted: December 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
August 31, 2011
September 5, 2011
December 11, 2013
August 2011
August 2013   (Final data collection date for primary outcome measure)
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 primary efficacy endpoint is the mean change in ADAS-Cog score from baseline to Week 12 of each treatment period. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01428362 on ClinicalTrials.gov Archive Site
  • 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 ]
The secondary efficacy endpoint is the mean change in MMSE score from baseline to Week 12 of each treatment period. [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
VI-1121 for the Treatment Alzheimer's Disease
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: VI-1121
  • Drug: Placebo
  • Experimental: Placebo/VI-1121
    Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.
    Interventions:
    • Drug: VI-1121
    • Drug: Placebo
  • Experimental: VI-1121/Placebo
    Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.
    Interventions:
    • Drug: VI-1121
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
August 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01428362
AD-201
No
Not Provided
Not Provided
VIVUS, Inc.
VIVUS, Inc.
Medpace, Inc.
Not Provided
VIVUS, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP