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Completed

NCT Number: NCT01428362

VI-1121 for the Treatment 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VI-1121

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study 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

Acronym: AD-201

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2011
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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