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Completed

NCT Number: NCT00104013

Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

sanofi-aventis Australia & New Zealand administrative office, Macquarie Park, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria
  • Mild to moderate degree of severity of dementia as assessed by the Mini-Mental Status Examination score of 16 to 26 (inclusive)
  • Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a stable dose for at least 6 months prior to the randomization and during the entire study period
  • Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
  • Mother tongue is English, Spanish or French (oral and written fluency)
  • Signed informed consent from potential participant or legal representative and identified caregiver

Exclusion criteria

  • Potential participant with any other cause of dementia.
  • Potential participant with serious health problems other than Alzheimer's disease
  • Use of an investigational drug within two months prior to randomization or during this study

Treatment and study plan

xaliproden (SR57746A)

Drug

Primary outcomes

  1. Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Secondary outcomes

  1. Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Feb 21, 2005
Registry last updated
Aug 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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