Ability to Drive of Early Stage Alzheimer Disease

NCT ID: NCT01566071

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Interventions

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Assessment of drive abilities

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JEAN-LUC NOVELLA, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Reims

Locations

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CHU de REIMS

Reims, France, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29782312 (View on PubMed)

Other Identifiers

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PN11009

Identifier Type: -

Identifier Source: org_study_id

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