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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359944
• Other study ID #: AC-3933-271
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2006
• Last updated: May 28, 2013
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: May 2013
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AC-3933
5mg twice daily
• AC-3933
AC-3933, 20 mg twice daily

Other:
• Sugar Pill
Sugar Pill twice daily

Locations

Country	Name	City	State
United States	Vertex Clinical Research	Bakersfield	California
United States	Neurological Research Center, Inc.	Bennington	Vermont
United States	East Bay Physicians Medical Grou[	Berkeley	California
United States	Memory Disorder Clinic	Deerfield Beach	Florida
United States	Odyssey Researcfh	Fargo	North Dakota
United States	Precise Research Centers INc.	Flowood	Mississippi
United States	Margolin Brain Institute	Fresno	California
United States	Berma Research Group	Hialeah	Florida
United States	The Clinical Trial Center	Jenkintown	Pennsylvania
United States	Clinical Trials Inc.	LIttle Rock	Alaska
United States	ClinicalStudies Center LLC	Little Rock	Arkansas
United States	UT Medical Group Inc.	Memphis	Tennessee
United States	Advanced Research Institute of Miami	Miami	Florida
United States	Research Center of Florida Inc.	Miami	Florida
United States	Research Institute of Miami	Miami	Florida
United States	Clinical Trials Associates	Mission Viejo	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals LLP	Oklahoma City	Oklahoma
United States	University of California	Orange	California
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Compass Research LLC	Orlando	Florida
United States	Four Rivers Clinical Research Inc.	Paducah	Kentucky
United States	PsyPharma Clinical Research Inc.	Phoenix	Arizona
United States	International Clinical Research Associates LLC	Richmond	Virginia
United States	Psych Care Consultants Research	Saint Louis	Missouri
United States	Clinical Psychopharmacology Consultants PA	Saint Louis Park	Minnesota
United States	Pacific Research Network	San Diego	California
United States	Internal Medicine Northwest	Tacoma	Washington
United States	Department of Psychiatry and Behavioral Medicine	Tampa	Florida
United States	Stedman Clinical Trials LLC	Tampa	Florida
United States	Northern Michigan Neurology	Traverse City	Michigan
United States	Tulsa Clinical Research LLC	Tulsa	Oklahoma
United States	The Center for Excellence in Aging and Geriatric Health	Williamsburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinicians Interview Based Impression of Change (CIBIC)-Plus	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.	Baseline to 16 weeks	No
Secondary	Disability Assessment for Dementia (DAD)	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.	Baseline to 16 Weeks	No