Alzheimer's DiseaseMERENCT01315704
Alzheimer's Disease and Related Disorders
An observational study of Alzheimer's Disease and Gait Apraxia, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Gait Apraxia, Impaired Cognition
- What is being tested?
- Drug intervention
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients of the University Memory Center of Angers University Hospital with respect to the eligibility criteria
Who may be able to join
- All elderly patients from the University Memory Center of Angers University Hospital.
- Able to walk without any walking aid on 15 meters
- Mini-Mental Status Examination score > 10
- Being affiliated to a social security regime
Who cannot join
- Mini-Mental Status Examination score ≤ 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
- Use of walking aid such as walking frame with wheels or tricycle.
- Acute medical or surgical disease in the past 3 months
- Refusal to participate (or trustworthy person)
- Near visual acuity < 2/10
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cédric ANNWEILER , MD
Angers, 49933
Cedric ANNWEILER, MD, (+33)241354725, ceannweiler@chu-angers.fr
About this study
Official title: Maladie d'Alzheimer et Maladies apparentées : Caractérisation Des Anomalies Cognitivo-motrices, et Des Effets Des médicaments Anti-démence et de la Vitamine D à Partir de la Mise en Place d'Une Base de données au CMRR du CHU d'Angers
The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.
Read the detailed description
Although gait disorders are frequently associated with Alzheimer's disease and related disorders (ADRD), few studies have focused on cognitive motor effects of anti-dementia drugs and vitamin D.
The objectives of this study are to
- Compare characteristics of gait and balance measured among patients with ADRD separated into 3 groups according to stages of disease (i.e., pre-dementia, mild and moderate dementia stages)
- To determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities
- To determine whether motor abnormalities could be associated with cognitive impairments, specifically executive dysfunctions
- To establish a database at Angers University Memory Center.
- Conditions
- Alzheimer's Disease, Gait Apraxia, Impaired Cognition
- Being tested
- Drug intervention
- Medical subject headings
- Alzheimer Disease, Gait Apraxia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug interventionDrug
Also called Anti-dementia drugs and/or vitamin D
before-after interventional (anti-dementia drugs and/or vitamin D) study
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with Mild Cognitive Impairment Receives: Drug: Drug intervention | |
| Group 2 | Patients with Mild Alzheimer's disease or related disorders Receives: Drug: Drug intervention | |
| Group 3 | Patients with Moderate Alzheimer's disease or related disorders Receives: Drug: Drug intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal gait parameters
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 completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Cedric ANNWEILER, MD, Principal investigator, Memory Centre of Angers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315704
- Sponsor's protocol ID
- 2009-15
- Acronym
- MERE
- Status last verified
- Mar 2011
- First submitted
- 11 Mar 2011
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Leonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.
PubMed 27568453Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.
PubMed 24261605
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maladie d'Alzheimer et Maladies apparentées : Caractérisation Des Anomalies Cognitivo-motrices, et Des Effets Des médicaments Anti-démence et de la Vitamine D à Partir de la Mise en Place d'Une Base de données au CMRR du CHU d'Angers
- ClinicalTrials.gov ID
- NCT01315704
- Acronym / sponsor ID
- MERE / 2009-15
- Conditions
- Alzheimer's Disease, Gait Apraxia, Impaired Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2009
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- 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 compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.
Detailed description
Although gait disorders are frequently associated with Alzheimer's disease and related disorders (ADRD), few studies have focused on cognitive motor effects of anti-dementia drugs and vitamin D.
The objectives of this study are to
- Compare characteristics of gait and balance measured among patients with ADRD separated into 3 groups according to stages of disease (i.e., pre-dementia, mild and moderate dementia stages)
- To determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities
- To determine whether motor abnormalities could be associated with cognitive impairments, specifically executive dysfunctions
- To establish a database at Angers University Memory Center.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Drug interventionPatients with Mild Cognitive Impairment |
| Group 2 | – | Drug: Drug interventionPatients with Mild Alzheimer's disease or related disorders |
| Group 3 | – | Drug: Drug interventionPatients with Moderate Alzheimer's disease or related disorders |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients of the University Memory Center of Angers University Hospital with respect to the eligibility criteria
Key inclusion criteria (4 listed)
- All elderly patients from the University Memory Center of Angers University Hospital.
- Able to walk without any walking aid on 15 meters
- Mini-Mental Status Examination score > 10
- Being affiliated to a social security regime
Key exclusion criteria (8 listed)
- Mini-Mental Status Examination score ≤ 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
- Use of walking aid such as walking frame with wheels or tricycle.
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 |
|---|---|---|
| Drug interventionAlso: Anti-dementia drugs and/or vitamin Dbefore-after interventional (anti-dementia drugs and/or vitamin D) study | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Spatiotemporal gait parameters
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
- Derived from this study: PubMed 27568453Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Leonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.
- Derived from this study: PubMed 24261605Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.
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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.
Cedric ANNWEILER, MD principal investigator
Memory Centre of Angers University Hospital
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 Alzheimer's Disease and Gait Apraxia, 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cedric ANNWEILER, DM ((+33) 241354725, ceannweiler@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatiotemporal gait parameters (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 NCT01315704, which also lists 2 linked publications.
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 15 Mar 2011.