- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01566071
Ability to Drive of Early Stage Alzheimer Disease (DRIVE COG)
November 21, 2025 updated by: CHU de Reims
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
France
-
Reims, France, France, 51092
- CHU de Reims
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JEAN-LUC NOVELLA, MD PhD, CHU de Reims
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion
December 7, 2022
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 27, 2012
First Submitted That Met QC Criteria
March 28, 2012
First Posted (Estimated)
March 29, 2012
Study Record Updates
Last Update Posted (Estimated)
November 26, 2025
Last Update Submitted That Met QC Criteria
November 21, 2025
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PN11009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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