Executive DysfunctionsEXEPANCT05311969
Prevalence of Impaired Executive Functions
A study testing cognitive evaluations and non cognitive evaluations in people with Executive Dysfunctions, run by Fondation Korian pour le Bien Vieillir at 8 sites in France.
Trial summary
The evaluation of executive functions, as well as the means of stimulating and preserving them, are at the heart of the challenges for maintaining a level of functional autonomy in the elderly, but also during the loss of this functional autonomy and when entering a situation of dependence and/or dementia. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Executive Dysfunctions
- What is being tested?
- cognitive evaluations and non cognitive evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesFrance
- Study dates
- 11 Apr 2022to 30 Jul 2023
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Permanent resident in Nursing Home or in temporary accommodation for more than 3 months
- speak and understand the French language
- Mini Mental State Examination (MMSE) between 7 and 24 dating from 8 maximum days
- Compulsorily affiliated with a social security scheme
- Agree to participate in the study in agreement with the trusted person (if applicable)
- co-signatures of the Consent Form between the investigator and the participant or the person of trust (if applicable)
Who cannot join
- Refusal to sign the consent form
- Resident in a specialized unit for behavioral disorders (Cognitive Behavioral Unit (CBU), Reinforced Accommodation Unit (RAU), Disoriented Elderly Unit (DEU), Centers of Natural Activities Drawn from Useful Occupations (NADUO) et cetera)
- Communication difficulties, sensory and/or motor deficits
- Medical contraindication in relation to a psychological state that could be altered due to participation in the study
- Resident at end of life (life expectancy < 3 months)
- Resident under legal protection
- Participation within 48 hours prior to inclusion in another research
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
KORIAN La Côte Sauvage
Ars-en-Ré, 17590
Korian Villa Louisa
Bordeaux, 33000
Korian Villa Evora
Chartres, 28000
Korian Le Catelli
L'Huisserie, 53970
Korian Doubs Rivage
Montbéliard, 25200
Korian Bois Robillard
Nantes, 44300
Korian Le Baron
Orléans, 45000
Korian Les Arcades
Paris, 75012
About this study
Official title: Prevalence of Impaired Executive Functions in Institutionalized Elderly
The evaluation of executive functions, as well as the means of stimulating and preserving them, are at the heart of the challenges for maintaining a level of functional autonomy in the elderly, but also during the loss of this functional autonomy and when entering a situation of dependence and/or dementia. Research that has demonstrated the preponderant role of executive functions on functional abilities are examples of this. Components such as planning, organization, initiation, mental flexibility appear to be strongly correlated with the effective performance of complex activities of daily living. In addition, the capacities for autonomy were found to be significantly reduced, and significantly with the severity of the executive deficits. In addition, if these data have since contributed to determining a level of impairment of the executive processes specific to an early loss of autonomy, they are so in the context of early diagnosis of dementia and validation of a detection tool, early loss of autonomy. The scientific advances of the last five years contribute to a better understanding of the impact of executive disorders, but on the other hand, the diversity of the explanatory phenomena of these disorders considerably complicates their nosology within neuro-evolutionary pathologies. Ultimately, an analysis of executive function disorders must take into account cognitive and behavioral aspects, that is to say, beyond performance on tests identified as involving executive functions, behavioral disorders, emotional status and level of autonomy in activities of daily living. In the state of our knowledge, the consideration of executive functions represents a strategic point at the crossroads of the evaluation of the act of care and treatment. Establishing data on the prevalence of alterations in the executive functions of residents, exploring the possibilities of evaluation with a battery of tests little used in this context and linking "executive" profiles and clinical situations seems to us a relevant and interesting first step. However essential to provide a beginning of answer to these questions. This study being an exploratory study. The results of this study will constitute new prevalence data in the population of residents of nursing homes. The aim here is to establish data on the prevalence of alterations in the executive functions of residents, to explore the possibilities of evaluation with a battery of tests little used in this context and to relate the profiles "executives" and clinical situations. This in order to develop a methodology to draw up a general assessment, and to make comparisons of the different profiles, inter/intra pathologies and stages of evolution. Thus, a more in-depth knowledge of the specific profiles of Nursing Home residents will also lead to the reflection of pharmacological and non-pharmacological therapeutic strategies. Finally, it will ultimately be a question of presenting an inventory of the situation of Nursing Home to alert public policies. The main objective is to study the prevalence of impaired executive functions in nursing home residents. The secondary objectives are to explore the feasibility of carrying out executive function tests and to examine the coorelationbetween the levels of impairment of executive functions and the clinical and functional characteristics of residents.
Read the detailed description
Participants will be recruited by the investigating doctor and the healthcare team. Participants must meet the defined inclusion criteria The steps:
- Screening Pre-selection of participants potentially eligible for the study (inclusion/non-inclusion criteria) and collection of data from medical records and the healthcare database. The information can be collected by the nursing coordinator of the Nursing home. The diagnosis will be determined by the investigating physician of each center and the inclusion criteria checked.
- Pre-inclusion-inclusion visit
- Confirmation of eligibility criteria for participants selected for the screening phase
- Delivery of Consent forms for reading, for explanation of the study methods (procedure, context, objective, constraints), and to answer any questions. If the participant agrees to participate in the study. The consent forms must be signed and dated before any act carried out within the framework of the research. A time of reflection can be granted before the signature. The evaluation of global cognitive functioning with the Mini Mental State Examination will be carried out. Each potentially eligible participant will be given an information note on the conduct of the study followed by an informed consent form that he and the investigator will need to sign before the start of the study. The course of the study for the participant will consist of 4 visits with the psychologist and/or the doctor: Pre-inclusion consultation, Visit 0: during which the participant will take a questionnaire carried out by the psychologist to assess overall cognitive functioning, and the inclusion consultation by the on-site investigator doctor to check whether the participant corresponds to all study criteria. Following this visit, the participant may choose to participate in the research by signing the consent form. The visits will take place as follows, spread over 14 to a maximum of 65 days from Pré-inclusion
- Visits
Visit 1. (20 to 45 minutes, up to 15 days after Visit 0). This visit will allow to do:
- a clinical assessment with the investigating doctor,
- a behavioral assessment by the nursing staff or the psychologist.
- four cognitive tests for a total duration of approximately 15 minutes carried out by the psychologist.
- Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 1.
Visit 2. (About 25 minutes, 7 to 10 days after visit Visit 1). This visit will allow you to:
- an evaluation of executive functions by the neuropsychologist with four new cognitive tests:
- Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 2.
Visit 3. (About 30 minutes, 7 to 10 days after visit Visit 2). This visit will allow you to:
- a final evaluation of executive functions by the neuropsychologist with four new cognitive tests:
- Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 3.
- Conditions
- Executive Dysfunctions
- Being tested
- cognitive evaluations and non cognitive evaluations
- Keywords
- executive functions, nursing home, resident, dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive evaluations and non cognitive evaluationsOther
Cognitive evaluations with executive functions evaluations :
- Mini Mental State Examination
- Stroop Victoria Test
- Hayling test
- Frontal Assessment Battery test mental flexibility:
- Trial Making Test (TMT) A and B
- Connection test
- Alphaflex test
- Verbal and visuospatial working memory
- Wechsler Adult Intelligence Scale (WAIS) span
- Visuo-spatial span
- Visuo-spatial span simplified version
- Month Of the Year Backwards (MOTYB) Planning
- Tinker Toy test
- Clock Test
Non-cognitive evaluations:
The Katz Autonomy Scale Neuropsychiatric Inventory version Care team Geriatric Depression Scale 15-item version Apathy inventory
| Study group | Role | What they receive |
|---|---|---|
| groups/cohort | Experimental | participants will perform the various neuropsychological tests provided for in the protocol Receives: Other: cognitive evaluations and non cognitive evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of executive functions impairment
Measured: 12 months
Secondary outcomes (3)
Rate of passed tests
ability of nursing home residents to pass tests provided for in the protocol to evaluate executive functions
Measured: 12 months
Correlation between executive functions impairment and percentage of dependence residents Correlation between executive functions impairment and percentage of residents with
Measured: 12 months
Correlation between executive functions impairment and behavioral disorders
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start11 Apr 2022
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Executive DysfunctionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Korian pour le Bien Vieillir
- Sponsor type
- University, hospital or other
- Collaborators
- Gerontopôle des Pays de la Loire
- Responsible party
- Sponsor
- Investigators
- Gilles BERRUT, Study director, Gerontopôle des Pays de la LoireLeila LAIFA-MARY, Principal investigator, KorianPriscilla CLOT-FAYBESSE, Principal investigator, Korian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311969
- Sponsor's protocol ID
- EXEPA
- Acronym
- EXEPA
- Status last verified
- Oct 2023
- First submitted
- 11 Mar 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.
PubMed 10945922Belleville S, Rouleau N, Van der Linden M. Use of the Hayling task to measure inhibition of prepotent responses in normal aging and Alzheimer's disease. Brain Cogn. 2006 Nov;62(2):113-9. doi: 10.1016/j.bandc.2006.04.006. Epub 2006 Jun 6.
PubMed 16757076Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
PubMed 7991117Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.
PubMed 11113214Fisk JE, Sharp CA. Age-related impairment in executive functioning: updating, inhibition, shifting, and access. J Clin Exp Neuropsychol. 2004 Oct;26(7):874-90. doi: 10.1080/13803390490510680.
PubMed 15742539KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
PubMed 14044222Makino T, Umegaki H, Suzuki Y, Yanagawa M, Nonogaki Z, Nakashima H, Kuzuya M. Relationship between small cerebral white matter lesions and cognitive function in patients with Alzheimer's disease and amnestic mild cognitive impairment. Geriatr Gerontol Int. 2014 Oct;14(4):819-26. doi: 10.1111/ggi.12176. Epub 2013 Nov 12.
PubMed 24215176Blanco Martin E, Ugarriza Serrano I, Elcoroaristizabal Martin X, Galdos Alcelay L, Molano Salazar A, Bereincua Gandarias R, Ingles Borda S, Uterga Valiente JM, Indakoetxea Juanbeltz MB, Moraza Lopez J, Barandiaran Amillano M, Fernandez-Martinez M. Dysexecutive syndrome in amnesic mild cognitive impairment: a multicenter study. BMC Neurol. 2016 Jun 4;16:88. doi: 10.1186/s12883-016-0607-2.
PubMed 27260328Perry RJ, Hodges JR. Differentiating frontal and temporal variant frontotemporal dementia from Alzheimer's disease. Neurology. 2000 Jun 27;54(12):2277-84. doi: 10.1212/wnl.54.12.2277.
PubMed 10881252Robert PH, Clairet S, Benoit M, Koutaich J, Bertogliati C, Tible O, Caci H, Borg M, Brocker P, Bedoucha P. The apathy inventory: assessment of apathy and awareness in Alzheimer's disease, Parkinson's disease and mild cognitive impairment. Int J Geriatr Psychiatry. 2002 Dec;17(12):1099-105. doi: 10.1002/gps.755.
PubMed 12461757Roussel M, Lhommee E, Narme P, Czernecki V, Gall DL, Krystkowiak P, Diouf M, Godefroy O; GREFEX study group. Dysexecutive syndrome in Parkinson's disease: the GREFEX study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2017 Sep;24(5):496-507. doi: 10.1080/13825585.2016.1226248. Epub 2016 Sep 1.
PubMed 27585478Salthouse TA, Toth J, Daniels K, Parks C, Pak R, Wolbrette M, Hocking KJ. Effects of aging on efficiency of task switching in a variant of the trail making test. Neuropsychology. 2000 Jan;14(1):102-11.
PubMed 10674802Stuss DT. Functions of the frontal lobes: relation to executive functions. J Int Neuropsychol Soc. 2011 Sep;17(5):759-65. doi: 10.1017/S1355617711000695. Epub 2011 May 24.
PubMed 21729406Stuss DT, Alexander MP, Shallice T, Picton TW, Binns MA, Macdonald R, Borowiec A, Katz DI. Multiple frontal systems controlling response speed. Neuropsychologia. 2005;43(3):396-417. doi: 10.1016/j.neuropsychologia.2004.06.010.
PubMed 15707616Tomaszewski Farias S, Cahn-Weiner DA, Harvey DJ, Reed BR, Mungas D, Kramer JH, Chui H. Longitudinal changes in memory and executive functioning are associated with longitudinal change in instrumental activities of daily living in older adults. Clin Neuropsychol. 2009 Apr;23(3):446-61. doi: 10.1080/13854040802360558. Epub 2008 Sep 23.
PubMed 18821181
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Impaired Executive Functions in Institutionalized Elderly
- ClinicalTrials.gov ID
- NCT05311969
- Acronym / sponsor ID
- EXEPA / EXEPA
- Conditions
- Executive Dysfunctions
- Keywords
- executive functions, nursing home, resident, dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fondation Korian pour le Bien VieillirUniversity, hospital or other
- Collaborators
- Gerontopôle des Pays de la Loire
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- 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 evaluation of executive functions, as well as the means of stimulating and preserving them, are at the heart of the challenges for maintaining a level of functional autonomy in the elderly, but also during the loss of this functional autonomy and when entering a situation of dependence and/or dementia. Research that has demonstrated the preponderant role of executive functions on functional abilities are examples of this. Components such as planning, organization, initiation, mental flexibility appear to be strongly correlated with the effective performance of complex activities of daily living. In addition, the capacities for autonomy were found to be significantly reduced, and significantly with the severity of the executive deficits. In addition, if these data have since contributed to determining a level of impairment of the executive processes specific to an early loss of autonomy, they are so in the context of early diagnosis of dementia and validation of a detection tool, early loss of autonomy. The scientific advances of the last five years contribute to a better understanding of the impact of executive disorders, but on the other hand, the diversity of the explanatory phenomena of these disorders considerably complicates their nosology within neuro-evolutionary pathologies. Ultimately, an analysis of executive function disorders must take into account cognitive and behavioral aspects, that is to say, beyond performance on tests identified as involving executive functions, behavioral disorders, emotional status and level of autonomy in activities of daily living. In the state of our knowledge, the consideration of executive functions represents a strategic point at the crossroads of the evaluation of the act of care and treatment. Establishing data on the prevalence of alterations in the executive functions of residents, exploring the possibilities of evaluation with a battery of tests little used in this context and linking "executive" profiles and clinical situations seems to us a relevant and interesting first step. However essential to provide a beginning of answer to these questions. This study being an exploratory study. The results of this study will constitute new prevalence data in the population of residents of nursing homes. The aim here is to establish data on the prevalence of alterations in the executive functions of residents, to explore the possibilities of evaluation with a battery of tests little used in this context and to relate the profiles "executives" and clinical situations. This in order to develop a methodology to draw up a general assessment, and to make comparisons of the different profiles, inter/intra pathologies and stages of evolution. Thus, a more in-depth knowledge of the specific profiles of Nursing Home residents will also lead to the reflection of pharmacological and non-pharmacological therapeutic strategies. Finally, it will ultimately be a question of presenting an inventory of the situation of Nursing Home to alert public policies. The main objective is to study the prevalence of impaired executive functions in nursing home residents. The secondary objectives are to explore the feasibility of carrying out executive function tests and to examine the coorelationbetween the levels of impairment of executive functions and the clinical and functional characteristics of residents.
Detailed description
Participants will be recruited by the investigating doctor and the healthcare team. Participants must meet the defined inclusion criteria The steps:
- Screening Pre-selection of participants potentially eligible for the study (inclusion/non-inclusion criteria) and collection of data from medical records and the healthcare database. The information can be collected by the nursing coordinator of the Nursing home. The diagnosis will be determined by the investigating physician of each center and the inclusion criteria checked.
- Pre-inclusion-inclusion visit
- Confirmation of eligibility criteria for participants selected for the screening phase
- Delivery of Consent forms for reading, for explanation of the study methods (procedure, context, objective, constraints), and to answer any questions. If the participant agrees to participate in the study. The consent forms must be signed and dated before any act carried out within the framework of the research. A time of reflection can be granted before the signature. The evaluation of global cognitive functioning with the Mini Mental State Examination will be carried out. Each potentially eligible participant will be given an information note on the conduct of the study followed by an informed consent form that he and the investigator will need to sign before the start of the study. The course of the study for the participant will consist of 4 visits with the psychologist and/or the doctor: Pre-inclusion consultation, Visit 0: during which the participant will take a questionnaire carried out by the psychologist to assess overall cognitive functioning, and the inclusion consultation by the on-site investigator doctor to check whether the participant corresponds to all study criteria. Following this visit, the participant may choose to participate in the research by signing the consent form. The visits will take place as follows, spread over 14 to a maximum of 65 days from Pré-inclusion
- Visits
Visit 1. (20 to 45 minutes, up to 15 days after Visit 0). This visit will allow to do:
- a clinical assessment with the investigating doctor,
- a behavioral assessment by the nursing staff or the psychologist.
- four cognitive tests for a total duration of approximately 15 minutes carried out by the psychologist.
- Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 1.
Visit 2. (About 25 minutes, 7 to 10 days after visit Visit 1). This visit will allow you to:
- an evaluation of executive functions by the neuropsychologist with four new cognitive tests:
- Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 2.
Visit 3. (About 30 minutes, 7 to 10 days after visit Visit 2). This visit will allow you to:
- a final evaluation of executive functions by the neuropsychologist with four new cognitive tests:
- Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 3.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| groups/cohort | Experimental | Other: cognitive evaluations and non cognitive evaluationsparticipants will perform the various neuropsychological tests provided for in the protocol |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Permanent resident in Nursing Home or in temporary accommodation for more than 3 months
- speak and understand the French language
- Mini Mental State Examination (MMSE) between 7 and 24 dating from 8 maximum days
- Compulsorily affiliated with a social security scheme
- Agree to participate in the study in agreement with the trusted person (if applicable)
Key exclusion criteria (7 listed)
- Refusal to sign the consent form
- Resident in a specialized unit for behavioral disorders (Cognitive Behavioral Unit (CBU), Reinforced Accommodation Unit (RAU), Disoriented Elderly Unit (DEU), Centers of Natural Activities Drawn from Useful Occupations (NADUO) et cetera)
- Communication difficulties, sensory and/or motor deficits
- Medical contraindication in relation to a psychological state that could be altered due to participation in the study
- Resident at end of life (life expectancy < 3 months)
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 |
|---|---|---|
| cognitive evaluations and non cognitive evaluationsCognitive evaluations with executive functions evaluations : * Mini Mental State Examination * Stroop Victoria Test * Hayling test * Frontal Assessment Battery test mental flexibility: * Trial Making Test (TMT) A and B * Connection test * Alphaflex test * Verbal and visuospatial working memory * Wechsler Adult Intelligence Scale (WAIS) span * Visuo-spatial span * Visuo-spatial span simplified version * Month Of the Year Backwards (MOTYB) Planning * Tinker Toy test * Clock Test Non-cognitive evaluations: The Katz Autonomy Scale Neuropsychiatric Inventory version Care team Geriatric Depression Scale 15-item version Apathy inventory | Other | groups/cohort |
Primary outcome
Prevalence of executive functions impairment
Time frame: 12 months
3 secondary outcomes
Rate of passed tests
Time frame: 12 months
Correlation between executive functions impairment and percentage of dependence residents Correlation between executive functions impairment and percentage of residents with
Time frame: 12 months
Correlation between executive functions impairment and behavioral disorders
Time frame: 12 months
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 27 Oct 2023.
- Background: PubMed 10945922Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.
- Background: PubMed 16757076Belleville S, Rouleau N, Van der Linden M. Use of the Hayling task to measure inhibition of prepotent responses in normal aging and Alzheimer's disease. Brain Cogn. 2006 Nov;62(2):113-9. doi: 10.1016/j.bandc.2006.04.006. Epub 2006 Jun 6.
- Background: PubMed 7991117Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
- Background: PubMed 11113214Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.
- Background: PubMed 15742539Fisk JE, Sharp CA. Age-related impairment in executive functioning: updating, inhibition, shifting, and access. J Clin Exp Neuropsychol. 2004 Oct;26(7):874-90. doi: 10.1080/13803390490510680.
- Background: PubMed 14044222KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
- Background: PubMed 24215176Makino T, Umegaki H, Suzuki Y, Yanagawa M, Nonogaki Z, Nakashima H, Kuzuya M. Relationship between small cerebral white matter lesions and cognitive function in patients with Alzheimer's disease and amnestic mild cognitive impairment. Geriatr Gerontol Int. 2014 Oct;14(4):819-26. doi: 10.1111/ggi.12176. Epub 2013 Nov 12.
- Background: PubMed 27260328Blanco Martin E, Ugarriza Serrano I, Elcoroaristizabal Martin X, Galdos Alcelay L, Molano Salazar A, Bereincua Gandarias R, Ingles Borda S, Uterga Valiente JM, Indakoetxea Juanbeltz MB, Moraza Lopez J, Barandiaran Amillano M, Fernandez-Martinez M. Dysexecutive syndrome in amnesic mild cognitive impairment: a multicenter study. BMC Neurol. 2016 Jun 4;16:88. doi: 10.1186/s12883-016-0607-2.
- Background: PubMed 10881252Perry RJ, Hodges JR. Differentiating frontal and temporal variant frontotemporal dementia from Alzheimer's disease. Neurology. 2000 Jun 27;54(12):2277-84. doi: 10.1212/wnl.54.12.2277.
- Background: PubMed 12461757Robert PH, Clairet S, Benoit M, Koutaich J, Bertogliati C, Tible O, Caci H, Borg M, Brocker P, Bedoucha P. The apathy inventory: assessment of apathy and awareness in Alzheimer's disease, Parkinson's disease and mild cognitive impairment. Int J Geriatr Psychiatry. 2002 Dec;17(12):1099-105. doi: 10.1002/gps.755.
- Background: PubMed 27585478Roussel M, Lhommee E, Narme P, Czernecki V, Gall DL, Krystkowiak P, Diouf M, Godefroy O; GREFEX study group. Dysexecutive syndrome in Parkinson's disease: the GREFEX study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2017 Sep;24(5):496-507. doi: 10.1080/13825585.2016.1226248. Epub 2016 Sep 1.
- Background: PubMed 10674802Salthouse TA, Toth J, Daniels K, Parks C, Pak R, Wolbrette M, Hocking KJ. Effects of aging on efficiency of task switching in a variant of the trail making test. Neuropsychology. 2000 Jan;14(1):102-11.
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.
Gilles BERRUT study director
Gerontopôle des Pays de la Loire
Leila LAIFA-MARY principal investigator
Korian
Priscilla CLOT-FAYBESSE principal investigator
Korian
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive evaluations and non cognitive evaluations in people with Executive Dysfunctions, run by Fondation Korian pour le Bien Vieillir at 8 sites 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 7 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Prevalence of executive functions impairment (time frame: 12 months). 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 NCT05311969, which also lists 18 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 27 Oct 2023.