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 (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00359944
First received: August 1, 2006
Last updated: May 28, 2013
Last verified: May 2013
  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
Other: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.


Secondary Outcome Measures:
  • Clinicians Interview Based Impression of Change (CIBIC)-Plus [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]

    Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.

    CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end.


  • Disability Assessment for Dementia (DAD) [ Time Frame: Baseline to 16 Weeks ] [ Designated as safety issue: No ]

    Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.

    The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction.



Enrollment: 171
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC-3933
AC-3933, 5mg twice daily
Drug: AC-3933
5mg twice daily
Experimental: AC-3933, 20 mg twice daily
AC-3933, 20 mg twice daily
Drug: AC-3933
AC-3933, 20 mg twice daily
Placebo Comparator: Placebo
Sugar Pill twice daily
Other: Sugar Pill
Sugar Pill twice daily
Other Name: Placebo

  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 acetylcholinesterase 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359944

  Show 34 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00359944     History of Changes
Other Study ID Numbers: AC-3933-271
Study First Received: August 1, 2006
Results First Received: April 11, 2011
Last Updated: May 28, 2013
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 September 11, 2014