Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT00359944
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- Mild to moderate Alzheimer's Disease
- Male or female 55 years or older
- Living with caregiver
- Read, understand and speak English
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC-3933 AC-3933 AC-3933, 5mg twice daily AC-3933, 20 mg twice daily AC-3933 AC-3933, 20 mg twice daily Placebo Sugar Pill Sugar Pill twice daily
- Primary Outcome Measures
Name Time Method Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) Baseline to 16 weeks 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
Name Time Method Clinicians Interview Based Impression of Change (CIBIC)-Plus Baseline to 16 weeks 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) Baseline to 16 Weeks 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.
Trial Locations
- Locations (33)
Clinical Trials Inc.
🇺🇸LIttle Rock, Alaska, United States
PsyPharma Clinical Research Inc.
🇺🇸Phoenix, Arizona, United States
ClinicalStudies Center LLC
🇺🇸Little Rock, Arkansas, United States
Vertex Clinical Research
🇺🇸Bakersfield, California, United States
East Bay Physicians Medical Grou[
🇺🇸Berkeley, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Clinical Trials Associates
🇺🇸Mission Viejo, California, United States
University of California
🇺🇸Orange, California, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Memory Disorder Clinic
🇺🇸Deerfield Beach, Florida, United States
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