Clinical trial NCT00359944: Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer
Dementia
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-03
Enrollment: 171
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Clinicians Interview Based Impression of Change (CIBIC)-Plus
timeFrame: Baseline to 16 weeks
measure: Disability Assessment for Dementia (DAD)
timeFrame: Baseline to 16 Weeks
Other outcomes:
Locations:
city: LIttle Rock
country: United States
facility: Clinical Trials Inc.
state: Alaska
city: Phoenix
country: United States
facility: PsyPharma Clinical Research Inc.
state: Arizona
city: Little Rock
country: United States
facility: ClinicalStudies Center LLC
state: Arkansas
city: Bakersfield
country: United States
facility: Vertex Clinical Research
state: California
city: Berkeley
country: United States
facility: East Bay Physicians Medical Grou[
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Mission Viejo
country: United States
facility: Clinical Trials Associates
state: California
city: Orange
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Deerfield Beach
country: United States
facility: Memory Disorder Clinic
state: Florida
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Miami
country: United States
facility: Advanced Research Institute of Miami
state: Florida
city: Miami
country: United States
facility: Research Institute of Miami
state: Florida
city: Miami
country: United States
facility: Research Center of Florida Inc.
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Compass Research LLC
state: Florida
city: Tampa
country: United States
facility: Department of Psychiatry and Behavioral Medicine
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials LLC
state: Florida
city: Paducah
country: United States
facility: Four Rivers Clinical Research Inc.
state: Kentucky
city: Traverse City
country: United States
facility: Northern Michigan Neurology
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Saint Louis Park
country: United States
facility: Clinical Psychopharmacology Consultants PA
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers INc.
state: Mississippi
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: Fargo
country: United States
facility: Odyssey Researcfh
state: North Dakota
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals LLP
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research LLC
state: Oklahoma
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Memphis
country: United States
facility: UT Medical Group Inc.
state: Tennessee
city: Bennington
country: United States
facility: Neurological Research Center, Inc.
state: Vermont
city: Richmond
country: United States
facility: International Clinical Research Associates LLC
state: Virginia
city: Williamsburg
country: United States
facility: The Center for Excellence in Aging and Geriatric Health
state: Virginia
city: Tacoma
country: United States
facility: Internal Medicine Northwest
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: