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Trial record 1 of 10 for:    AD201
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VI-1121 for the Treatment Alzheimer's Disease (AD-201)

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. Identifier: NCT01428362
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : December 11, 2013
Medpace, Inc.
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: VI-1121 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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: 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.
Drug: VI-1121
Drug: Placebo

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01428362

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United States, California
San Francisco, California, United States, 94109
Santa Monica, California, United States, 90404
United States, Florida
Sunrise, Florida, United States, 33351
United States, Kentucky
Louisville, Kentucky, United States, 40217
United States, Nevada
Las Vegas, Nevada, United States, 89113
United States, New Jersey
Toms River, New Jersey, United States, 08755
United States, New York
New Windsor, New York, United States, 12553
United States, North Carolina
Durham, North Carolina, United States, 27710
Raleigh, North Carolina, United States, 27612
United States, Ohio
Toledo, Ohio, United States, 43623
United States, Texas
Plano, Texas, United States, 75075
Sponsors and Collaborators
Medpace, Inc.
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Responsible Party: VIVUS, Inc. Identifier: NCT01428362    
Other Study ID Numbers: AD-201
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: November 2013
Keywords provided by VIVUS, Inc.:
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders