Abstract ThinkingNCT01100281
Prefrontal Cortex and Abstract Thinking
An observational study of Abstract Thinking and Concept Formation, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The capacity of concept formation is not well understood, even if a link is supposed with the functioning of the frontal lobes. Our aim is to better understand the cognitive mechanisms underlying this function and to try to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abstract Thinking, Concept Formation
- What is being tested?
- Neuropsychological examination and MRI
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Apr 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 groups including : PSP, FTD, AD
Who may be able to join
- informed consent signed
- MMSE> 20
- No contra indication to MRI
Who cannot join
- MMSE<20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuropsychological and Anatomical Study of Concept Formation in Frontal Patients
The capacity of concept formation is not well understood, even if a link is supposed with the functioning of the frontal lobes.
Our aim is to better understand the cognitive mechanisms underlying this function and to try to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases involving this region (frontotemporal lobar degeneration and progressive supranuclear palsy).
- Conditions
- Abstract Thinking, Concept Formation
- Being tested
- Neuropsychological examination, MRI
- Keywords
- prefrontal cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological examinationBehavioural
Examination including especially concept formation
MRIOther
MRI performed in T1-weighted three dimensional sequence
| Study group | Role | What they receive |
|---|---|---|
| PSP (Progressive supranuclear palsy) | Not described Receives: Behavioral: Neuropsychological examination; Other: MRI | |
| FTD (Frontotemporal lobar degenerative) | Not described Receives: Behavioral: Neuropsychological examination; Other: MRI | |
| Alzheimer's disease | Not described Receives: Behavioral: Neuropsychological examination; Other: MRI |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abstract ThinkingStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Richard Levy, MD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100281
- Sponsor's protocol ID
- C09-29
- Status last verified
- Dec 2011
- First submitted
- 7 Apr 2010
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological and Anatomical Study of Concept Formation in Frontal Patients
- ClinicalTrials.gov ID
- NCT01100281
- Acronym / sponsor ID
- C09-29
- Conditions
- Abstract Thinking, Concept Formation
- Keywords
- prefrontal cortex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Apr 2010
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Apr 2010 (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 capacity of concept formation is not well understood, even if a link is supposed with the functioning of the frontal lobes.
Our aim is to better understand the cognitive mechanisms underlying this function and to try to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases involving this region (frontotemporal lobar degeneration and progressive supranuclear palsy).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSP (Progressive supranuclear palsy) | – | Behavioral: Neuropsychological examination, Other: MRI |
| FTD (Frontotemporal lobar degenerative) | – | Behavioral: Neuropsychological examination, Other: MRI |
| Alzheimer's disease | – | Behavioral: Neuropsychological examination, Other: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups including : PSP, FTD, AD
Key inclusion criteria (3 listed)
- informed consent signed
- MMSE> 20
- No contra indication to MRI
Key exclusion criteria (1 listed)
- MMSE<20
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 |
|---|---|---|
| Neuropsychological examinationExamination including especially concept formation | Behavioural | Alzheimer's disease, FTD (Frontotemporal lobar degenerative), PSP (Progressive supranuclear palsy) |
| MRIMRI performed in T1-weighted three dimensional sequence | Other | Alzheimer's disease, FTD (Frontotemporal lobar degenerative), PSP (Progressive supranuclear palsy) |
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 9 Dec 2011.
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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.
Richard Levy, MD study director
Institut National de la Santé Et de la Recherche Médicale, France
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 Abstract Thinking and Concept Formation, run by Institut National de la Santé Et de la Recherche Médicale, 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 3 inclusion and 1 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 9 Dec 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?
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?
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 9 Dec 2011.