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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AC-3933
AC-3933
Sugar Pill
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer, Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Trials Inc.
  • PsyPharma Clinical Research Inc.
  • ClinicalStudies Center LLC
  • Vertex Clinical Research
  • East Bay Physicians Medical Grou[
  • Margolin Brain Institute
  • Clinical Trials Associates
  • University of California
  • Pacific Research Network
  • Memory Disorder Clinic
  • Berma Research Group
  • Advanced Research Institute of Miami
  • Research Institute of Miami
  • Research Center of Florida Inc.
  • Medical Research Group of Central Florida
  • Compass Research LLC
  • Department of Psychiatry and Behavioral Medicine
  • Stedman Clinical Trials LLC
  • Four Rivers Clinical Research Inc.
  • Northern Michigan Neurology
  • Clinical Psychopharmacology Consultants PA
  • Precise Research Centers INc.
  • Psych Care Consultants Research
  • Odyssey Researcfh
  • Paradigm Research Professionals LLP
  • Cutting Edge Research Group
  • Tulsa Clinical Research LLC
  • The Clinical Trial Center
  • UT Medical Group Inc.
  • Neurological Research Center, Inc.
  • International Clinical Research Associates LLC
  • The Center for Excellence in Aging and Geriatric Health
  • Internal Medicine Northwest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AC-3933

AC-3933, 20 mg twice daily

Placebo

Arm Description

AC-3933, 5mg twice daily

AC-3933, 20 mg twice daily

Sugar Pill twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 1, 2006
Last Updated
May 28, 2013
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00359944
Brief Title
Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC-3933
Arm Type
Experimental
Arm Description
AC-3933, 5mg twice daily
Arm Title
AC-3933, 20 mg twice daily
Arm Type
Experimental
Arm Description
AC-3933, 20 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar Pill twice daily
Intervention Type
Drug
Intervention Name(s)
AC-3933
Intervention Description
5mg twice daily
Intervention Type
Drug
Intervention Name(s)
AC-3933
Intervention Description
AC-3933, 20 mg twice daily
Intervention Type
Other
Intervention Name(s)
Sugar Pill
Other Intervention Name(s)
Placebo
Intervention Description
Sugar Pill twice daily
Primary Outcome Measure Information:
Title
Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)
Description
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
Secondary Outcome Measure Information:
Title
Clinicians Interview Based Impression of Change (CIBIC)-Plus
Description
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
Title
Disability Assessment for Dementia (DAD)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trials Inc.
City
LIttle Rock
State/Province
Alaska
ZIP/Postal Code
72205
Country
United States
Facility Name
PsyPharma Clinical Research Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
ClinicalStudies Center LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Vertex Clinical Research
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
East Bay Physicians Medical Grou[
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Clinical Trials Associates
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
University of California
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Memory Disorder Clinic
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Advanced Research Institute of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Research Institute of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Research Center of Florida Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Compass Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Department of Psychiatry and Behavioral Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Stedman Clinical Trials LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Four Rivers Clinical Research Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Northern Michigan Neurology
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
53454
Country
United States
Facility Name
Clinical Psychopharmacology Consultants PA
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Precise Research Centers INc.
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
37232
Country
United States
Facility Name
Psych Care Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Odyssey Researcfh
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Paradigm Research Professionals LLP
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Tulsa Clinical Research LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
The Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
UT Medical Group Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Neurological Research Center, Inc.
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
International Clinical Research Associates LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
The Center for Excellence in Aging and Geriatric Health
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
Facility Name
Internal Medicine Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

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

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