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OpenTrials
Completed

NCT Number: NCT00380302

Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.

Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill).

Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.

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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 1 / Phase 2

Primary location

Sanofi-Aventis Administrative Office, Paris, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The diagnosis of Alzheimer's disease
  • Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI)
  • Mild to moderate range of disease; not too severe

Exclusion criteria

  • Severe or unstable medical diseases
  • Neurological disorder other than Alzheimer's disease
  • Depression that is not well controlled
  • Treatment with memantine
  • Inpatient in a total care facility (e.g.: Nursing home)
  • Lack of reliable caregiver

Treatment and study plan

AVE1625

Drug

Primary outcomes

  1. Safety and tolerability throughout the study:adverse events collected by spontaneous report

  2. physical examination and neurological assessment

  3. vital sign monitoring, clinical laboratories, and ECGs.

  4. Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.

Secondary outcomes

  1. Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Double-Blind Placebo-Controlled Study of the Activity of AVE1625 at Doses of 10 mg and 40mg for 12 Weeks in Patients With Mild to Moderate Alzheimer's Disease

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 25, 2006
Registry last updated
Dec 19, 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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