Ability to Drive of Early Stage Alzheimer Disease | NCT01566071

Studies
Ability to Drive of Early Stage Alzheimer Disease

NCT01566071

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Nov 26, 2025Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Alzheimer Disease

Interventions

Assessment of drive abilities

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Not provided

Completion Date

Jul 2015Actual

First Submitted Date

Mar 27, 2012

First Submission Date that Met QC Criteria

Mar 28, 2012

First Posted Date

Mar 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2025

Last Update Posted Date

Nov 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
Assessment of drive abilities	Other

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
JEAN-LUC NOVELLA, MD PhD	CHU de Reims	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU de REIMS		Reims	France	51092	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29782312	Background	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.

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases