Ability to Drive of Early Stage Alzheimer Disease

Alzheimer Disease Clinical Trial

— DRIVE COG  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566071
• Other study ID #: PN11009
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: June 8, 2016
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: June 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• Assessment of drive abilities

Locations

Country	Name	City	State
France	CHU de REIMS	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France,