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

NCT ID: NCT00359944

Last Updated: 2013-07-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-09-30

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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AC-3933

AC-3933, 5mg twice daily

Group Type EXPERIMENTAL

AC-3933

Intervention Type DRUG

5mg twice daily

AC-3933, 20 mg twice daily

AC-3933, 20 mg twice daily

Group Type EXPERIMENTAL

AC-3933

Intervention Type DRUG

AC-3933, 20 mg twice daily

Placebo

Sugar Pill twice daily

Group Type PLACEBO_COMPARATOR

Sugar Pill

Intervention Type OTHER

Sugar Pill twice daily

Interventions

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AC-3933

5mg twice daily

Intervention Type DRUG

AC-3933

AC-3933, 20 mg twice daily

Intervention Type DRUG

Sugar Pill

Sugar Pill twice daily

Intervention Type OTHER

Other Intervention Names

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Placebo

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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

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Clinical Trials Inc.

LIttle Rock, Alaska, United States

Site Status

PsyPharma Clinical Research Inc.

Phoenix, Arizona, United States

Site Status

ClinicalStudies Center LLC

Little Rock, Arkansas, United States

Site Status

Vertex Clinical Research

Bakersfield, California, United States

Site Status

East Bay Physicians Medical Grou[

Berkeley, California, United States

Site Status

Margolin Brain Institute

Fresno, California, United States

Site Status

Clinical Trials Associates

Mission Viejo, California, United States

Site Status

University of California

Orange, California, United States

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

Memory Disorder Clinic

Deerfield Beach, Florida, United States

Site Status

Berma Research Group

Hialeah, Florida, United States

Site Status

Advanced Research Institute of Miami

Miami, Florida, United States

Site Status

Research Institute of Miami

Miami, Florida, United States

Site Status

Research Center of Florida Inc.

Miami, Florida, United States

Site Status

Medical Research Group of Central Florida

Orange City, Florida, United States

Site Status

Compass Research LLC

Orlando, Florida, United States

Site Status

Department of Psychiatry and Behavioral Medicine

Tampa, Florida, United States

Site Status

Stedman Clinical Trials LLC

Tampa, Florida, United States

Site Status

Four Rivers Clinical Research Inc.

Paducah, Kentucky, United States

Site Status

Northern Michigan Neurology

Traverse City, Michigan, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

Clinical Psychopharmacology Consultants PA

Saint Louis Park, Minnesota, United States

Site Status

Precise Research Centers INc.

Flowood, Mississippi, United States

Site Status

Psych Care Consultants Research

St Louis, Missouri, United States

Site Status

Odyssey Researcfh

Fargo, North Dakota, United States

Site Status

Paradigm Research Professionals LLP

Oklahoma City, Oklahoma, United States

Site Status

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Site Status

Tulsa Clinical Research LLC

Tulsa, Oklahoma, United States

Site Status

The Clinical Trial Center

Jenkintown, Pennsylvania, United States

Site Status

UT Medical Group Inc.

Memphis, Tennessee, United States

Site Status

Neurological Research Center, Inc.

Bennington, Vermont, United States

Site Status

International Clinical Research Associates LLC

Richmond, Virginia, United States

Site Status

The Center for Excellence in Aging and Geriatric Health

Williamsburg, Virginia, United States

Site Status

Internal Medicine Northwest

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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AC-3933-271

Identifier Type: -

Identifier Source: org_study_id

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