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
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: VI-1121
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 61
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428362

Locations
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
VIVUS, Inc.
Medpace, Inc.
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT01428362     History of Changes
Other Study ID Numbers: AD-201
Study First Received: August 31, 2011
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by VIVUS, Inc.:
donepezil
VI-1121

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014