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Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Sunovion
ClinicalTrials.gov Identifier:
NCT00359944
First received: August 1, 2006
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.


Condition Intervention Phase
Alzheimer's Disease
 Drug: AC-3933
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Assessing the Efficacy and Safety of AC-3933 Tablets Twice Daily in Adults With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • ADAS-Cog

Secondary Outcome Measures:
  • CIBIC-Plus
  • DAD

Estimated Enrollment: 160
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate Alzheimer's Disease
  • Male or female 55 years or older
  • Living with caregiver
  • Read, understand and speak English

Exclusion Criteria:

  • Need to drive during the study
  • Treatment with acethylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study
  • Frequent Smoker
  • Frequent Consumer of Caffeine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359944

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States, 35802
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85013
Phoenix, Arizona, United States, 85050
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Bakersfield, California, United States, 93311
Berkeley, California, United States, 94705
Fresno, California, United States, 93720
Laguna Hills, California, United States, 92653
Orange, California, United States, 92868
United States, Florida
Deerfield Beach, Florida, United States, 33064
Hialeah, Florida, United States, 33016
Miami, Florida, United States, 33173
Miami, Florida, United States, 33134
Orange City, Florida, United States, 32763
Tampa, Florida, United States, 33613
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Michigan
Traverse City, Michigan, United States, 49684
United States, Minnesota
Minneapolis, Minnesota, United States, 53454
United States, Missouri
Saint Louis, Missouri, United States, 63128
United States, New York
Albany, New York, United States, 12205
United States, North Dakota
Fargo, North Dakota, United States, 58104
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73116
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
United States, Tennessee
Memphis, Tennessee, United States, 38105
United States, Texas
Houston, Texas, United States, 77074
McKinney, Texas, United States, 75070
United States, Vermont
Bennington, Vermont, United States, 05201
United States, Virginia
Richmond, Virginia, United States, 23229
Williamsburg, Virginia, United States, 23185
United States, Washington
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00359944     History of Changes
Other Study ID Numbers: AC-3933-271
Study First Received: August 1, 2006
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Alzheimer
Dementia

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 June 17, 2013