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

Sumitomo Pharma

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Other: Sugar Pill; Drug: AC-3933

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359944

AC-3933-271

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 3 patient groups, including a placebo group

AC-3933

Experimental group

Description:

AC-3933, 5mg twice daily

Treatment:

Drug: AC-3933

Drug: AC-3933

AC-3933, 20 mg twice daily

Experimental group

Description:

AC-3933, 20 mg twice daily

Treatment:

Drug: AC-3933

Drug: AC-3933

Placebo

Placebo Comparator group

Description:

Sugar Pill twice daily

Treatment:

Other: Sugar Pill