Phase 2 N=154 Randomized Double-blind Treatment

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

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00359944 ↗

Enrolled (actual)

154

Serious AEs

9.1%

Results posted

Jul 2013

Primary outcome: Primary: Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) — -1.3; -2.9; -1.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AC-3933 (Drug); Sugar Pill (Other)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Sumitomo Pharma America, Inc.
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)	-1.3; -2.9; -1.5	—
SECONDARY Clinicians Interview Based Impression of Change (CIBIC)-Plus	4.1; 3.9; 3.9	—
SECONDARY Disability Assessment for Dementia (DAD)	-2.7; 4.0; 4.2	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00359944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.