Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
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
1 other identifier
interventional
171
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2006
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 1, 2006
CompletedFirst Posted
Study publicly available on registry
August 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
July 2, 2013
CompletedJuly 2, 2013
May 1, 2013
2.6 years
August 1, 2006
April 11, 2011
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)
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.
Baseline to 16 weeks
Secondary Outcomes (2)
Clinicians Interview Based Impression of Change (CIBIC)-Plus
Baseline to 16 weeks
Disability Assessment for Dementia (DAD)
Baseline to 16 Weeks
Study Arms (3)
AC-3933
EXPERIMENTALAC-3933, 5mg twice daily
AC-3933, 20 mg twice daily
EXPERIMENTALAC-3933, 20 mg twice daily
Placebo
PLACEBO COMPARATORSugar Pill twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Mild to moderate Alzheimer's Disease
- Male or female 55 years or older
- Living with caregiver
- Read, understand and speak English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Clinical Trials Inc.
LIttle Rock, Alaska, 72205, United States
PsyPharma Clinical Research Inc.
Phoenix, Arizona, 85013, United States
ClinicalStudies Center LLC
Little Rock, Arkansas, 72205, United States
Vertex Clinical Research
Bakersfield, California, 93311, United States
East Bay Physicians Medical Grou[
Berkeley, California, 94705, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Clinical Trials Associates
Mission Viejo, California, 92691, United States
University of California
Orange, California, 92868, United States
Pacific Research Network
San Diego, California, 92103, United States
Memory Disorder Clinic
Deerfield Beach, Florida, 33064, United States
Berma Research Group
Hialeah, Florida, 33016, United States
Advanced Research Institute of Miami
Miami, Florida, 33135, United States
Research Institute of Miami
Miami, Florida, 33135, United States
Research Center of Florida Inc.
Miami, Florida, 33173, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Compass Research LLC
Orlando, Florida, 32806, United States
Department of Psychiatry and Behavioral Medicine
Tampa, Florida, 33613, United States
Stedman Clinical Trials LLC
Tampa, Florida, 33613, United States
Four Rivers Clinical Research Inc.
Paducah, Kentucky, 42003, United States
Northern Michigan Neurology
Traverse City, Michigan, 49684, United States
Unknown Facility
Minneapolis, Minnesota, 53454, United States
Clinical Psychopharmacology Consultants PA
Saint Louis Park, Minnesota, 55416, United States
Precise Research Centers INc.
Flowood, Mississippi, 37232, United States
Psych Care Consultants Research
St Louis, Missouri, 63128, United States
Odyssey Researcfh
Fargo, North Dakota, 58104, United States
Paradigm Research Professionals LLP
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Tulsa Clinical Research LLC
Tulsa, Oklahoma, 74104, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
UT Medical Group Inc.
Memphis, Tennessee, 38105, United States
Neurological Research Center, Inc.
Bennington, Vermont, 05201, United States
International Clinical Research Associates LLC
Richmond, Virginia, 23229, United States
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, 23185, United States
Internal Medicine Northwest
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, CNS
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2006
First Posted
August 3, 2006
Study Start
February 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
July 2, 2013
Results First Posted
July 2, 2013
Record last verified: 2013-05