VI-1121 for the Treatment Alzheimer's Disease (AD-201)
This study is ongoing, but not recruiting participants.
Sponsor:
VIVUS, Inc.
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by VIVUS, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 61 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
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.
|
| Experimental: VI-1121 |
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.
|
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
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: | May 8, 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 May 16, 2013