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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
171
5mg twice daily
AC-3933, 20 mg twice daily
Sugar Pill twice daily
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.
Time frame: Baseline to 16 weeks
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.
Time frame: Baseline to 16 weeks
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.
Time frame: Baseline to 16 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 24 more locations