European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2007 by Bellus Health Inc.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

Bellus Health Inc

ClinicalTrials.gov Identifier:

NCT00217763

First received: September 14, 2005

Last updated: December 7, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

December 7, 2007

Start Date ^ICMJE

September 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00217763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients

Official Title ^ICMJE

A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease

Brief Summary

The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

Detailed Description

Duration of treatment: 18 months
3 treatment arms:

Placebo and 2 different doses of active drug.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: 3APS

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

930

Estimated Completion Date

December 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES.

INCLUSION CRITERIA:

Participants must meet the following inclusion criteria to be eligible.

Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
Potential participant must be treated with an acetylcholinesterase inhibitor (donepezil, galantamine or rivastigmine) and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
Participants must not have taken memantine for at least 4 months prior to the commencement of screening. The use of memantine is prohibited during the course of the study.
Fluency (oral and written) in the language in which the standardized tests will be administered.
Signed informed consent from potential participant or legal representative and caregiver.

EXCLUSION CRITERIA:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

Potential participant with any other cause of dementia.
Life expectancy less than 2 years.
Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
Previous use of anti-amyloid or vaccine treatment for Alzheimer's disease.
Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
Previous exposure to 3APS.
Inability to swallow pills.

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00217763

Other Study ID Numbers ^ICMJE

CL-758010

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Bellus Health Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pr. Bruno Vellas

University Hospital Center, Toulouse

PRS Account

Bellus Health Inc

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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