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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Medpace, Inc.

Information provided by (Responsible Party):

VIVUS, Inc.

ClinicalTrials.gov Identifier:

NCT01428362

First received: August 31, 2011

Last updated: May 8, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2011
Last Updated Date	May 8, 2013
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01428362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 31, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	VI-1121 for the Treatment Alzheimer's Disease
Official Title ^ICMJE	A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: VI-1121 Crossover design with subjects receiving either placebo or VI-1121 during a 12 week treatment period followed by treatment with the alternate treatment for 12 weeks. Drug: Placebo Crossover design with subjects receiving either placebo or VI-1121 during a 12 week treatment period followed by treatment with the alternate treatment for 12 weeks.
Study Arm (s)	Placebo Comparator: Placebo Intervention: Drug: Placebo Experimental: VI-1121 Intervention: Drug: VI-1121
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	61
Estimated Completion Date	September 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	60 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01428362
Other Study ID Numbers ^ICMJE	AD-201
Has Data Monitoring Committee	No
Responsible Party	VIVUS, Inc.
Study Sponsor ^ICMJE	VIVUS, Inc.
Collaborators ^ICMJE	Medpace, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	VIVUS, Inc.
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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