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Ability to Drive of Early Stage Alzheimer Disease (DRIVE COG)

This study is not yet open for participant recruitment.
Verified March 2012 by CHU de Reims
Sponsor:
Information provided by (Responsible Party):
CHU de Reims
ClinicalTrials.gov Identifier:
NCT01566071
First received: March 27, 2012
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

The main objectives of this study are:

  • To evaluate the driving capacities in a population of elderly subjects with early stage Alzheimer Disease (AD) in a real-life situation.
  • Define a typology of the main errors made in this population.
  • Propose adaptive measures or technological aids that would make it possible for these patients to maintain their ability to drive a car while limiting risk.

Condition Intervention
Alzheimer Disease
 Other: Assessment of drive abilities

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CHU de Reims:

Estimated Enrollment: 60
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The following subjects will be included and classified as " patients " :

  • Age > 70 years
  • With established diagnosis of Alzheimer's disease as defined by DSM IV
  • With MMSE score ≥ 24 (early-stage Alzheimer's disease)
  • Holder of a valid driving license
  • With regular driving activity (drives at least once per week)
  • Informed consent provided.

The following subjects will be included and classified as " controls " :

  • Age > 70 years,
  • Absence of cognitive impaired that interferes with their daily life at initial evaluation,
  • Holder of a valid driving license,
  • With regular driving activity (drives at least once per week),
  • Informed consent provided.

Exclusion Criteria:

  • Dementia syndrome(s) other than Alzheimer's disease,
  • MMSE score < 24
  • Informed consent not provide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566071

Contacts
Contact: Jean-Luc NOVELLA jlnovella@chu-reims.fr

Locations
France
CHU de REIMS Not yet recruiting
Reims, France, 51092
Contact: Jean-Luc NOVELLA, MD PhD         jlnovella@chu-reims.fr    
Principal Investigator: Jean-Luc NOVELLA, MD PhD            
Sponsors and Collaborators
CHU de Reims
Investigators
Principal Investigator: JEAN-LUC NOVELLA, MD PhD CHU de Reims
  More Information

No publications provided

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT01566071     History of Changes
Other Study ID Numbers: REIMS-PHRCNAT2011-N11-02
Study First Received: March 27, 2012
Last Updated: March 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013