Back to resultsAbility to Drive of Early Stage Alzheimer Disease (DRIVE COG)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of drive abilities
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease
Eligibility 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
Sites / Locations
- CHU de REIMS
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01566071
Brief Title
Ability to Drive of Early Stage Alzheimer Disease
Acronym
DRIVE COG
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Assessment of drive abilities
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEAN-LUC NOVELLA, MD PhD
Organizational Affiliation
CHU de Reims
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de REIMS
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Ability to Drive of Early Stage Alzheimer Disease
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