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

November 15, 2013 updated by: VIVUS LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
      • Santa Monica, California, United States, 90404
    • Florida
      • Sunrise, Florida, United States, 33351
    • Kentucky
      • Louisville, Kentucky, United States, 40217
    • Nevada
      • Las Vegas, Nevada, United States, 89113
    • New Jersey
      • Toms River, New Jersey, United States, 08755
    • New York
      • New Windsor, New York, United States, 12553
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Raleigh, North Carolina, United States, 27612
    • Ohio
      • Toledo, Ohio, United States, 43623
    • Texas
      • Plano, Texas, United States, 75075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo/VI-1121
Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.
Drug: Placebo
Drug: VI-1121
Experimental: VI-1121/Placebo
Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.
Drug: Placebo
Drug: VI-1121

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
4, 8, and 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Collaborators

Medpace, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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