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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CHU de Reims
ClinicalTrials.gov Identifier:
NCT01566071
First received: March 27, 2012
Last updated: June 8, 2016
Last verified: June 2016

March 27, 2012
June 8, 2016
July 2012
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Complete list of historical versions of study NCT01566071 on ClinicalTrials.gov Archive Site
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Ability to Drive of Early Stage Alzheimer Disease
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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.
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Interventional
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Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Alzheimer Disease
Other: Assessment of drive abilities
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2015
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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
Both
70 Years and older   (Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01566071
PN11009
No
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CHU de Reims
CHU de Reims
Not Provided
Principal Investigator: JEAN-LUC NOVELLA, MD PhD CHU de Reims
CHU de Reims
June 2016

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