Gait ApraxiaGAITNCT01315717
Gait and Alzheimer Interaction Tracking (GAIT) Study
An observational study of Gait Apraxia and Alzheimer Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait Apraxia, Alzheimer Disease, Impaired Cognition
- How many people
- 912 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to May 2016
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients of the University Memory Center of Angers Hospital with respect to the eligibility criteria.
Who may be able to join
- Age ≥ 60 years
- Able to walk without walking aid on 15 metres
- Score of Mini-Mental Examination (MMSE) > 10
- Written informed consent to participate in the study (or trustworthy person)
- Being affiliated to a social security regime
- Near visual acuity ≥ 2/10
- Absence of severe depression (score in the 15-item Geriatric Depression Scale ≤ 10)
Who cannot join
- Score of Mini-Mental Examination (MMSE) ≤ 10
- Subject suffering from pre-existing impellent disturbances
- History of cerebrovascular accident or other cerebro-spinal pathology
- Poor workmanship of the written or oral French language
- Refusal of subject to be informed on possible hanging bare anomaly during study
- Use of walking aid
Show all 11Show fewer
- Acute medical or surgical disease in the past 3 months
- Refusal to participate (or trustworthy person)
- Contra-indication to the achievement of a Magnetic Resonance Imaging
- Near visual acuity < 2/10
- Presence of severe depression (score in the 15-item Geriatric Depression Scale > 10)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs
The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).
Read the detailed description
Although gait disorders are frequently associated with Alzheimer's disease (AD), few studies have focused on their characterization and mechanism. Exploring the associations of the gait characteristics - more particularly the gait variability - with the cognitive performance of AD patients on one hand, and with the morphological brain abnormalities on the other hand, could be useful to understanding the mechanisms of gait disorders in AD.
The main objective of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).
- Conditions
- Gait Apraxia, Alzheimer Disease, Impaired Cognition, Cerebral Atrophy
- Medical subject headings
- Gait Apraxia, Alzheimer Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Healthy subjects | |
| Group 2 | Patients with Mild Cognitive Impairment | |
| Group 3 | Patients with Mild AD | |
| Group 4 | Patients with Moderate AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride-to-stride variability of stride time
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startNov 2009
- Primary completionMay 2016
- Study completionMay 2016
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 Gait ApraxiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olivier Beauchet, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315717
- Sponsor's protocol ID
- 2009-A00533-54
- Acronym
- GAIT
- Status last verified
- Mar 2011
- First submitted
- 10 Mar 2011
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Graffe A, Beauchet O, Fantino B, Milea D, Annweiler C. Vitamin D and macular thickness in the elderly: an optical coherence tomography study. Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):5298-303. doi: 10.1167/iovs.14-13918.
PubMed 25028353
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs
- ClinicalTrials.gov ID
- NCT01315717
- Acronym / sponsor ID
- GAIT / 2009-A00533-54
- Conditions
- Gait Apraxia, Alzheimer Disease, Impaired Cognition, Cerebral Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2009
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Mar 2011 (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 purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).
Detailed description
Although gait disorders are frequently associated with Alzheimer's disease (AD), few studies have focused on their characterization and mechanism. Exploring the associations of the gait characteristics - more particularly the gait variability - with the cognitive performance of AD patients on one hand, and with the morphological brain abnormalities on the other hand, could be useful to understanding the mechanisms of gait disorders in AD.
The main objective of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Healthy subjects |
| Group 2 | – | –Patients with Mild Cognitive Impairment |
| Group 3 | – | –Patients with Mild AD |
| Group 4 | – | –Patients with Moderate AD |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of the University Memory Center of Angers Hospital with respect to the eligibility criteria.
Key inclusion criteria (7 listed)
- Age ≥ 60 years
- Able to walk without walking aid on 15 metres
- Score of Mini-Mental Examination (MMSE) > 10
- Written informed consent to participate in the study (or trustworthy person)
- Being affiliated to a social security regime
Key exclusion criteria (11 listed)
- Score of Mini-Mental Examination (MMSE) ≤ 10
- Subject suffering from pre-existing impellent disturbances
- History of cerebrovascular accident or other cerebro-spinal pathology
- Poor workmanship of the written or oral French language
- Refusal of subject to be informed on possible hanging bare anomaly during study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stride-to-stride variability of stride time
Time frame: baseline
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 22 Sep 2016.
- Derived from this study: PubMed 25028353Graffe A, Beauchet O, Fantino B, Milea D, Annweiler C. Vitamin D and macular thickness in the elderly: an optical coherence tomography study. Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):5298-303. doi: 10.1167/iovs.14-13918.
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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.
Olivier Beauchet, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Apraxia and Alzheimer Disease, run by University Hospital, Angers 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 7 inclusion and 11 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 22 Sep 2016. 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.
What does the primary outcome measure?
Stride-to-stride variability of stride time (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315717, 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 22 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.