NCT01566071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 26, 2025

Status Verified

June 1, 2016

First QC Date

March 27, 2012

Last Update Submit

November 21, 2025

Conditions

Alzheimer Disease

Interventions

Assessment of drive abilitiesOTHER

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Dementia syndrome(s) other than Alzheimer's disease,
  • MMSE score \< 24
  • Informed consent not provide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de REIMS

Reims, France, 51092, France

Location

Related Publications (1)

  • Paire-Ficout L, Lafont S, Conte F, Coquillat A, Fabrigoule C, Ankri J, Blanc F, Gabel C, Novella JL, Morrone I, Mahmoudi R. Naturalistic Driving Study Investigating Self-Regulation Behavior in Early Alzheimer's Disease: A Pilot Study. J Alzheimers Dis. 2018;63(4):1499-1508. doi: 10.3233/JAD-171031.

    PMID: 29782312BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • JEAN-LUC NOVELLA, MD PhD

    CHU de Reims

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

July 1, 2012

Study Completion

July 1, 2015

Last Updated

November 26, 2025

Record last verified: 2016-06

Locations

FR(1)