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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

  Show 32 Study Locations
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 May 22, 2013