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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566071
First Posted: March 29, 2012
Last Update Posted: June 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CHU de Reims
  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:


Further study details as provided by CHU de Reims:

Enrollment: 60
Study Start Date: July 2012
Study Completion Date: July 2015
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566071


Locations
France
CHU de REIMS
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
Investigators
Principal Investigator: JEAN-LUC NOVELLA, MD PhD CHU de Reims
  More Information

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT01566071     History of Changes
Other Study ID Numbers: PN11009
First Submitted: March 27, 2012
First Posted: March 29, 2012
Last Update Posted: June 9, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders