Alzheimer's DiseaseNCT01993628
Construction-LBD (Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD))
A study testing Rey figure test and MRI in people with Alzheimer's Disease and Lewy Body's Dementia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative pathologies. They differ in their expression, their evolution but share same features which make their diagnosis uneasy. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Alzheimer's Disease, Lewy Body's Dementia
- What is being tested?
- Rey figure test and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Nov 2016
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimer's disease or Lewy bodies dementia
- ≥ 45 years
- the cognitive impairment is mild to moderate
- French speaker
- a caregiver is present
- An informed consent is signed by the patient and the p.i.
Who cannot join
- MRI contraindication
- Other neurological disease (FTD, brain tumor, vascular disease…)
- Psychiatric disease (Schizophrenia, major depression, psychotic disorders, melancholia…)
- Patient who doesn't want to be informed in case of the discovery of an abnormality
- View or audition deficits, or motor disability which can interfere with the cognitive testing
- Patient participating to an exclusive protocol or in the period of exclusion
Show all 10Show fewer
- Pregnant woman
- Person under an administrative or legal measure of liberty privation
- Person under a legal measure of protection or under administrative supervision
- Person unable to give his consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Xavier De Pétigny, Docteur, 3 88 12 79 25 ext. 0033, xavier.depetigny@chru-strasbourg.fr
About this study
Official title: Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD)
Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative pathologies. They differ in their expression, their evolution but share same features which make their diagnosis uneasy.
Constructional apraxia has been described in both disease.The underlying mechanisms have been less studied and could be different in AD and LBD.
Read more
The definition of the constructional apraxia is purely descriptive and few models are inconclusive.
It is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities, executive functions and working memory as well as purely "constructive" skills.
Regarding to different studies, visuo-perceptive abilities are more severely impaired in LBD than in AD and are considered as an early onset sign of the disease.
Executive functions deficits are documented in AD and LDB and could contribute to the drawing impairment.
It is possible to compensate the planning disorders in giving patient the best strategy to use.
If drawing impairment persists, they should result of others mechanisms like visuo-perception, visuo-spatial or constructive deficits.
The investigators suggest that giving the best planning strategy will help more AD patients who are supposed to fail in raison of an executive impairment, than the LDB group who is supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral areas involved in constructional apraxia.
- Conditions
- Alzheimer's Disease, Lewy Body's Dementia
- Being tested
- Rey figure test, MRI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rey figure testOther
MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease (AD) | Experimental | Rey figure test and MRI Receives: Other: Rey figure test; Other: MRI |
| Lewy body's dementia (LBD) | Experimental | Rey figure test and MRI Receives: Other: Rey figure test; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score obtained at the Rey figure test with a planning strategy help by LBD patients compared to the score obtained by AD patients.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993628
- Sponsor's protocol ID
- 5565
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD)
- ClinicalTrials.gov ID
- NCT01993628
- Acronym / sponsor ID
- 5565
- Conditions
- Alzheimer's Disease, Lewy Body's Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 25 Nov 2013 (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.
Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative pathologies. They differ in their expression, their evolution but share same features which make their diagnosis uneasy.
Constructional apraxia has been described in both disease.The underlying mechanisms have been less studied and could be different in AD and LBD.
The definition of the constructional apraxia is purely descriptive and few models are inconclusive.
It is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities, executive functions and working memory as well as purely "constructive" skills.
Regarding to different studies, visuo-perceptive abilities are more severely impaired in LBD than in AD and are considered as an early onset sign of the disease.
Executive functions deficits are documented in AD and LDB and could contribute to the drawing impairment.
It is possible to compensate the planning disorders in giving patient the best strategy to use.
If drawing impairment persists, they should result of others mechanisms like visuo-perception, visuo-spatial or constructive deficits.
The investigators suggest that giving the best planning strategy will help more AD patients who are supposed to fail in raison of an executive impairment, than the LDB group who is supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral areas involved in constructional apraxia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease (AD) | Experimental | Other: Rey figure test, Other: MRIRey figure test and MRI |
| Lewy body's dementia (LBD) | Experimental | Other: Rey figure test, Other: MRIRey figure test and MRI |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Alzheimer's disease or Lewy bodies dementia
- ≥ 45 years
- the cognitive impairment is mild to moderate
- French speaker
- a caregiver is present
Key exclusion criteria (10 listed)
- MRI contraindication
- Other neurological disease (FTD, brain tumor, vascular disease…)
- Psychiatric disease (Schizophrenia, major depression, psychotic disorders, melancholia…)
- Patient who doesn't want to be informed in case of the discovery of an abnormality
- View or audition deficits, or motor disability which can interfere with the cognitive testing
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 |
|---|---|---|
| Rey figure test | Other | Alzheimer's disease (AD), Lewy body's dementia (LBD) |
| MRI | Other | Alzheimer's disease (AD), Lewy body's dementia (LBD) |
Primary outcome
Score obtained at the Rey figure test with a planning strategy help by LBD patients compared to the score obtained by AD patients.
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rey figure test and MRI in people with Alzheimer's Disease and Lewy Body's Dementia, run by University Hospital, Strasbourg, France 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 6 inclusion and 10 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 25 Nov 2013. 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 Xavier DE PETIGNY, Docteur (3 88 11 56 24 ext. 0033, xavier.depetigny@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score obtained at the Rey figure test with a planning strategy help by LBD patients compared to the score obtained by AD patients. (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2013.