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Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

This study has been terminated.
(Insufficient expected benefit risk)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00602680
First received: January 16, 2008
Last updated: July 17, 2009
Last verified: July 2009
History of Changes
  Purpose

The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.


Condition Intervention Phase
Alzheimer's Disease
 Drug: SSR180711C
Drug: donepezil
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in cognitive performance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive, global, functional and behaviorial assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose 1
 Drug: SSR180711C
duration of treatment: 4 weeks
Experimental: 2
dose 2
 Drug: SSR180711C
duration of treatment: 4 weeks
Experimental: 3
dose 3
 Drug: SSR180711C
duration of treatment: 4 weeks
Placebo Comparator: 4 Drug: placebo
duration of treatment: 4 weeks
Active Comparator: 5 Drug: donepezil
duration of treatment: 4 weeks

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with diagnosis of mild AD

Exclusion Criteria:

  • Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
  • Medical condition which may interfere with the study
  • History of epileptic seizures
  • Lens opacity
  • Lack of reliable caregiver

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602680

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Bruno DUBOIS, MD Scientific Advisory Committee
  More Information

No publications provided

Responsible Party: ICD study director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00602680     History of Changes
Other Study ID Numbers: PDY10400, SSR180711, EudraCT 2007-001639-80
Study First Received: January 16, 2008
Last Updated: July 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Alzheimer
cognitive

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013