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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: AC-3933
* Drug: AC-3933
* Other: Sugar Pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC-3933<br>AC-3933, 5mg twice daily | Drug: AC-3933<br>* 5mg twice daily<br>|
| Experimental: AC-3933, 20 mg twice daily<br>AC-3933, 20 mg twice daily | Drug: AC-3933<br>* AC-3933, 20 mg twice daily<br>|
| Placebo Comparator: Placebo<br>Sugar Pill twice daily | Other: Sugar Pill<br>* Sugar Pill twice daily<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer, Dementia