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

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01428362
First received: August 31, 2011
Last updated: November 15, 2013
Last verified: November 2013

August 31, 2011
November 15, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
The secondary efficacy endpoint is the mean change in MMSE score from baseline to Week 12 of each treatment period. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
60 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01428362
AD-201
No
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