VI-1121 for the Treatment Alzheimer's Disease

NCT ID: NCT01428362

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Keywords

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donepezil VI-1121

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo/VI-1121

Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.

Group Type EXPERIMENTAL

VI-1121

Intervention Type DRUG

Placebo

Intervention Type DRUG

VI-1121/Placebo

Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.

Group Type EXPERIMENTAL

VI-1121

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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VI-1121

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

VIVUS LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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San Francisco, California, United States

Site Status

Santa Monica, California, United States

Site Status

Sunrise, Florida, United States

Site Status

Louisville, Kentucky, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Toms River, New Jersey, United States

Site Status

New Windsor, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Toledo, Ohio, United States

Site Status

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AD-201

Identifier Type: -

Identifier Source: org_study_id