Alzheimer DiseaseDRIVE COGNCT01566071
Ability to Drive of Early Stage Alzheimer Disease
A study testing Assessment of drive abilities in people with Alzheimer Disease, run by CHU de Reims at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Assessment of drive abilities
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- Dementia syndrome(s) other than Alzheimer's disease,
- MMSE score < 24
- Informed consent not provide
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Assessment of drive abilities
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of drive abilitiesOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJul 2012
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JEAN-LUC NOVELLA, MD PhD, Principal investigator, CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566071
- Sponsor's protocol ID
- PN11009
- Acronym
- DRIVE COG
- Status last verified
- Jun 2016
- First submitted
- 27 Mar 2012
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29782312
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability to Drive of Early Stage Alzheimer Disease
- ClinicalTrials.gov ID
- NCT01566071
- Acronym / sponsor ID
- DRIVE COG / PN11009
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jul 2012
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (3 listed)
- Dementia syndrome(s) other than Alzheimer's disease,
- MMSE score < 24
- Informed consent not provide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of drive abilities | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 29782312Paire-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JEAN-LUC NOVELLA, MD PhD principal investigator
CHU de Reims
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of drive abilities in people with Alzheimer Disease, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.