Alzheimer DiseaseMEMTRAV-COGNCT06321380
Working Memory Functioning in Alzheimer's Disease and Vascular Dementia
An observational study of Alzheimer Disease and Vascular Dementia, run by University Hospital, Grenoble.
Trial summary
The aim of the present study is to investigate potential cognitive mechanisms contributing to working memory impairment in Alzheimer's disease and vascular dementia. The investigators consider a new hypothesis suggesting that difficulties in mobilizing maintenance strategies of information could explain this working… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Vascular Dementia, Mixed Dementias
- What is being tested?
- Complex span task, Clinical neuropsychological assessment and Clinical neurospychological assessement
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Oct 2025
- How long will I take part?
- 1 Day
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The population of this study will consist of patients performing a neuropsychological assessment at Grenoble-Alpes University Hospital. These patients consult because of cognitive disorders. The patients are dividied into these three subgroups according to their medical diagnosis of Alzheimer's disease, vascular dementia, or mixed dementia (diagnostic criteria : Dubois et al. (2021) for Alzheimer's disease; VASCOG diagnostic criteria : Sachdev et al., 2015 for vascular dementia; and diagnostic criteria : DSM-V (APA, 2013) for mixed dementia due to Alzheimer and vascular etiology). The population of this study will also include healthy participants (carers/visitors of patients at the Gerontology centre or volunteers at Gerontology centre).
Who may be able to join
- For patient and control groups: Adults ≥ 65 years of age
- For patient and control groups: Native French speaker
- For patient and control groups: Vision for easy reading
- For patient and control groups: Hearing for easy instruction understanding
- For patient and control groups: Back span ≥ 3 during the "Digit Span Backward" subtest (WAIS-IV)
- For patient and control groups: Formulation of the non-opposition to participate in this study
Show all 14Show fewer
- For patient group only: Consultation in Grenoble University Hospital (Centre de Gérontologie Sud - Gerontology center) for clinical neuropsychological assessment due to suspected cognitive impairment
- For patient group only: Diagnosis of Alzheimer's disease, vascular dementia, or mixed dementia (i.e., Alzheimer's disease and vascular dementia)
- For patient group only: Have undergone a neuropsychological assessment at the day clinic, less than 6 months old.
- For patient group only: Have obtained a medical opinion stating that there is no contraindication to participate in this study and no concurrent pathology that could impair the patient's cognitive abilities.
- For patient group only: Absence of praxis and language disorders thath might prevent the carrying out of the experimental task.
- For patient group only: MMSE score between 18 and 25 included
- For control group only: External visitor/carer of a patient/resident of Grenoble University Hospital or volunteers at Grenoble University Hospital.
- For control group only: MMSE score ≥ 26
Who cannot join
- For patient and control groups: People under guardianship or deprived of their freedom
- For patient and control groups: Diagnosis of severe psychiatric disorders
- For patient and control groups: Suspicion of pathologies related to alcohol dependence
- For patient and control groups: No French social security coverage
- For patient and control groups: Refusal to voluntarily participate in this study
- For patient and control groups: People covered by articles L1121-5 to L1121-8 of the French Public Health Code
- For patient group only: Suspicion of another neurodegenerative disease, such as fronto-temporal dementia, Parkinson's disease, Lewy body disease.
- For patient group only: Clinical neuropsychological assessment did not reveal any cognitive impairment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Working Memory Maintenance Mechanisms in Alzheimer's Disease and Vascular Dementia
The aim of the present study is to investigate potential cognitive mechanisms contributing to working memory impairment in Alzheimer's disease and vascular dementia. The investigators consider a new hypothesis suggesting that difficulties in mobilizing maintenance strategies of information could explain this working memory deficit. More specifically, the investigators assume that patient groups will have difficulties in employing both refreshing and elaborative strategies during a working memory task (i.e., complex span task), as compared to a control group.
Read the detailed description
Working memory is considered as a central hub in human cognition. Good working memory capacities are fundamental for daily life. However, previous research has indicated that patients with Alzheimer's disease or vascular dementia have significant working memory impairment. Currently, there is no consensus on the cognitive mechanisms responsible for this deficit. Prior findings have highlighted that patients with Alzheimer's disease and/or vascular dementia demonstrate specific difficulties in dual-task situations. In this context, the investigators hypothesize that the continuous alternation between maintenance and processing phases involved in working memory could be impaired for these patients. Thus, the aim of the present study is to investigate if patients with Alzheimer's disease and/or vascular dementia can use maintenance strategies of information in working memory, as typically observed in individuals without cognitive impairments.
To this end, the investigators propose a short working memory task in which they manipulate the opportunities to use refreshing strategies and elaborative strategies. The investigators expect that patients with Alzheimer's disease, vascular dementia, or mixed dementia will benefit less than healthy older adults from the increased opportunities to employ refreshing and elaboration. These difficulties could account for the impaired working memory performance associated with these diseases.
In a second step, the investigators formulate distinctive hypotheses between patient sub-groups:
- On the one hand, Alzheimer's disease is characterized by salient impairment of episodic long-term memory. Consequently, the investigators hypothesize that the working memory decline could be related to this deficit in long-term memory. Specifically, patients with Alzheimer's disease would have greater difficulty in implementing elaboration strategies. Thus, these patients' recall performance should benefit less from semantic links between the to-be-remembered items compared to patients with vascular dementia.
- On the other hand, vascular dementia is characterized by a significant impairment of executive functioning. Thus, the investigators hypothesize that the working memory decline could be related to difficulties in implementing refreshing strategies (i.e., voluntary control of attention). Thus, the recall performance of these patients should benefit less from increased free time during the task, compared to patients with Alzheimer's disease.
- Finally, very few studies have been carried out on patients with mixed dementia (from both Alzheimer's disease and vascular dementia). The investigators assume that the recall performance of these patients will benefit less from elaborative opportunities compared to patients with dementia vascular, and less from refreshing opportunities compared to patients with Alzheimer's disease.
- Conditions
- Alzheimer Disease, Vascular Dementia, Mixed Dementias
- Being tested
- Complex span task, Clinical neuropsychological assessment, Clinical neurospychological assessement
- Keywords
- Working memory, Alzheimer disease, Vascular dementia, Mixed dementia, Complex span task
- Medical subject headings
- Alzheimer Disease, Dementia, Vascular, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex span taskBehavioural
Also called Working memory task
The intervention consists in a computerized working memory task. This task follows the design of a complex span task, involving alternation between memorization and processing steps.
For each trial, participants have to memorize French words. These words are sequentially displayed on the screen. Between each word, participants perform a processing task consisting in a spatial location task: They have to determine if a shape is at the top or at the bottom of the screen. After each processing episode, participants have a free time (i.e., available time to maintain information in WM). At the end of each trial, participants perform an orally immediate recall. This experimental task involves several conditions in order to manipulate the opportunities for the spontaneous use of refreshing and elaborative strategies.
Clinical neuropsychological assessmentDiagnostic test
As part of routine care, participants in the patient group undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions. The investigators hypothesize correlations between working memory performance during the experimental task and the results of neuropsychological tests. Thus, the investigators consider the results to several French versions of neuropsychological tests:
- MMSE (Mini-Mental State Examination)
- "Digit Span Backward" subtest (WAIS-IV)
- Stroop Test
- Trail Making Test (TMT)
- Rappel Libre - Rappel Indicé à 16 items or GERIA-12
- Category fluences
- Instrumental Activities of Daily Living and ADL .
Clinical neurospychological assessementDiagnostic test
Participants in the control group undergo 2 tests clinical that evaluate cognitive functioning.
The investigators consider the results to French versions of these neuropsychological tests:
- MMSE (Mini-Mental State Examination; )
- "Digit Span Backward" subtest (WAIS-IV)
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer disease | Alzheimer's disease is define on the basis of the medical diagnostic. As part of routine care, they undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions.
For the study and during the day of medical consultations, each patient will perform a working memory task, lasting approximately 30 minutes.
If the patient is accompanied by a family member, the investigators ask the latter to complete a questionnaire on patient's daily executive functioning (French version of the Behavior rating inventory of executive function [BRIEF-A]). Receives: Behavioral: Complex span task; Diagnostic Test: Clinical neuropsychological assessment | |
| Vascular dementia | Vascular dementia is define on the basis of the medical diagnostic. As part of routine care, they undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions.
For the study and during the day of medical consultations, each patient will perform a working memory task, lasting approximately 30 minutes.
If the patient is accompanied by a family member, the investigators ask the latter to complete a questionnaire on patient's daily executive functioning (French version of the Behavior rating inventory of executive function [BRIEF-A]). Receives: Behavioral: Complex span task; Diagnostic Test: Clinical neuropsychological assessment | |
| Mixed dementia | Mixed dementia (i.e., Alzheimer's disease and vascular dementia) is define on the basis of the medical diagnostic. As part of routine care, they undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions .
For the study and during the day of medical consultations, each patient will perform a working memory task, lasting approximately 30 minutes.
If the patient is accompanied by a family member, the investigators ask the latter to complete a questionnaire on patient's daily executive functioning (French version of the Behavior rating inventory of executive function [BRIEF-A]). Receives: Behavioral: Complex span task; Diagnostic Test: Clinical neuropsychological assessment | |
| Control group | Control group includes healthy older adults (without cognitive impairment). As patient group, control group will perform the working memory task. However, control group does not undergo the clinical neuropsychological assessment. Receives: Behavioral: Complex span task; Diagnostic Test: Clinical neurospychological assessement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory performance in the Working memory task
Percentage of correct immediate recall, computed with strict serial recall criterion (item identity + correct position) and computed with item recall criterion (item identity only).
Measured: 15 minutes
Processing performance in the Working memory task
Percentage of correct response in the spatial part of working memory task
Measured: 15 minutes
Reaction time
Reaction time for each distractor (in ms) in the spatial part of working memory task
Measured: 30 minutes
Secondary outcomes (20)
Mini-Mental State Examination (MMSE)
MMSE is a test evaluate global cognitive functioning Score from 0 to 30 A higher score mean a better cognitive efficiency
Measured: 15 minutes
Digit span forward WAIS IV (digit number)
The participant's span is noted, corresponding to the longest number of sequential digits that can be repeated forward.
Measured: 5 minutes
Digit span forward WAIS IV (standard note)
This scale permitted to obtain a standard note from 0 to 19 A higher score means a better performance
Measured: 5 minutes
Digit span backward WAIS IV (digit number)
The participant's span is noted, corresponding to the longest number of sequential digits that can be repeated backward.
Measured: 5 minutes
Digit span backward WAIS IV (standard note)
This scale permitted to obtain a standard note from 0 to 19 A higher score means a better performance
Measured: 5 minutes
Stroop Test - denomination part
the denomination part of stroop test measures processing speed time is taken, in seconds
Measured: 30 secondes
Stroop Test - minor interference part (Time)
this part of stroop test measures low inhibition process time is taken, in seconds
Measured: 30 secondes
Stroop Test - minor interference part (errors)
this part of stroop test measures low inhibition process number of errors is noted, from 0 to 24
Measured: 30 secondes
Stroop Test - major interference part (time)
this part of stroop test measures strong inhibition process time is taken, in seconds
Measured: 90 secondes
Stroop Test - major interference part (errors)
this part of stroop test measures strong inhibition process number of errors is noted, from 0 to 24
Measured: 90 secondes
Trail Making Test - Part A (time)
This test evaluate motor speed processing Time in seconds
Measured: 2 minutes
Trail Making Test - Part A (errors)
This test evaluates motor speed processing Number of errors is noted
Measured: 2 minutes
Trail Making Test - Part B (time)
This test evaluates mental flexibility Time in seconds
Measured: 5 minutes
Trail Making Test - Part B (errors)
This test evaluates mental flexibility Number of errors is noted
Measured: 5 minutes
Category fluences
Number of correct words is noted
Measured: 5 minutes
Memory evaluation (16-item Free and Cued Recall, or GERIA-12)
These tests evaluate verbal episodic memory Scores are noted for each trail, from 0 to 16 (RL-RI/16) or 0 to 12 (Geria-12) A higher score means a better performance
Measured: 40 minutes
Naming task
This test evaluate the capacity to correctly name a picture Score is noted, from 0 to 40 A higher score means a better performance
Measured: 40 minutes
Behavior rating inventory of executive function
Questionnaire (french version) on patient's daily executive functioning, completed by a relative of the patient, if present Global score from 75 to 225, composing by several composite scores. A higher score means a more severe executive dysfonctionning in daily life
Measured: 10 minutes
Instrumental Activities of Daily Living
Questionnaire completed by a professional (nurse or doctor) with the patient and an accompagniant if present Score from 0 to 8 A higher score mean a better autonomy in daily life
Measured: 5 minutes
Activities of Daily Living
Questionnaire completed by a professional (nurse or doctor) with the patient and an accompagniant if present Score from 0 to 6 A higher score mean a better autonomy in daily life
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, Université Savoie Mont Blanc, Centre National de la Recherche Scientifique, France, Laboratoire de Psychologie et NeuroCognition
- Responsible party
- Sponsor
- Investigators
- Benoit Lemaire, Study chair, Laboratoire de Psychologie et NeuroCognitionSophie Portrat, Study chair, Laboratoire de Psychologie et NeuroCognition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321380
- Sponsor's protocol ID
- 38RC23.0381
- Acronym
- MEMTRAV-COG
- Status last verified
- Mar 2024
- First submitted
- 5 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartsch LM, Singmann H, Oberauer K. The effects of refreshing and elaboration on working memory performance, and their contributions to long-term memory formation. Mem Cognit. 2018 Jul;46(5):796-808. doi: 10.3758/s13421-018-0805-9.
PubMed 29557069Belleville S, Chertkow H, Gauthier S. Working memory and control of attention in persons with Alzheimer's disease and mild cognitive impairment. Neuropsychology. 2007 Jul;21(4):458-69. doi: 10.1037/0894-4105.21.4.458.
PubMed 17605579Camos V, Johnson M, Loaiza V, Portrat S, Souza A, Vergauwe E. What is attentional refreshing in working memory? Ann N Y Acad Sci. 2018 Jul;1424(1):19-32. doi: 10.1111/nyas.13616. Epub 2018 Mar 15.
PubMed 29542133Conway AR, Kane MJ, Bunting MF, Hambrick DZ, Wilhelm O, Engle RW. Working memory span tasks: A methodological review and user's guide. Psychon Bull Rev. 2005 Oct;12(5):769-86. doi: 10.3758/bf03196772.
PubMed 16523997Inasaridze K, Foley JA, Logie RH, Sala SD. Dual task impairments in vascular dementia. Behav Neurol. 2010;22(1-2):45-52. doi: 10.3233/BEN-2009-0252.
PubMed 20543458Zheng C, Zhang RS, Wan T, Zhao JS. Topological Alterations of Working Memory Impairment in Aged Patients With Vascular Dementia. Front Aging Neurosci. 2021 Oct 4;13:741445. doi: 10.3389/fnagi.2021.741445. eCollection 2021.
PubMed 34675799Baddeley AD, Baddeley HA, Bucks RS, Wilcock GK. Attentional control in Alzheimer's disease. Brain. 2001 Aug;124(Pt 8):1492-508. doi: 10.1093/brain/124.8.1492.
PubMed 11459742Belleville S, Peretz I, Malenfant D. Examination of the working memory components in normal aging and in dementia of the Alzheimer type. Neuropsychologia. 1996 Mar;34(3):195-207. doi: 10.1016/0028-3932(95)00097-6.
PubMed 8868277Foley JA, Cocchini G, Logie RH, Della Sala S. No dual-task practice effect in Alzheimer's disease. Memory. 2015;23(4):518-28. doi: 10.1080/09658211.2014.908922. Epub 2014 Apr 30.
PubMed 24787541Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Gagnon LG, Belleville S. Working memory in mild cognitive impairment and Alzheimer's disease: contribution of forgetting and predictive value of complex span tasks. Neuropsychology. 2011 Mar;25(2):226-36. doi: 10.1037/a0020919.
PubMed 21090897Jahn H. Memory loss in Alzheimer's disease. Dialogues Clin Neurosci. 2013 Dec;15(4):445-54. doi: 10.31887/DCNS.2013.15.4/hjahn.
PubMed 24459411Jellinger KA, Attems J. Prevalence and pathology of vascular dementia in the oldest-old. J Alzheimers Dis. 2010;21(4):1283-93. doi: 10.3233/jad-2010-100603.
PubMed 21504129KATZ 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 14044222Korczyn AD, Vakhapova V, Grinberg LT. Vascular dementia. J Neurol Sci. 2012 Nov 15;322(1-2):2-10. doi: 10.1016/j.jns.2012.03.027. Epub 2012 May 8.
PubMed 22575403
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Working Memory Maintenance Mechanisms in Alzheimer's Disease and Vascular Dementia
- ClinicalTrials.gov ID
- NCT06321380
- Acronym / sponsor ID
- MEMTRAV-COG / 38RC23.0381
- Conditions
- Alzheimer Disease, Vascular Dementia, Mixed Dementias
- Keywords
- Working memory, Alzheimer disease, Vascular dementia, Mixed dementia, Complex span task
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps, Université Savoie Mont Blanc, Centre National de la Recherche Scientifique, France, Laboratoire de Psychologie et NeuroCognition
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Mar 2024 (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 aim of the present study is to investigate potential cognitive mechanisms contributing to working memory impairment in Alzheimer's disease and vascular dementia. The investigators consider a new hypothesis suggesting that difficulties in mobilizing maintenance strategies of information could explain this working memory deficit. More specifically, the investigators assume that patient groups will have difficulties in employing both refreshing and elaborative strategies during a working memory task (i.e., complex span task), as compared to a control group.
Detailed description
Working memory is considered as a central hub in human cognition. Good working memory capacities are fundamental for daily life. However, previous research has indicated that patients with Alzheimer's disease or vascular dementia have significant working memory impairment. Currently, there is no consensus on the cognitive mechanisms responsible for this deficit. Prior findings have highlighted that patients with Alzheimer's disease and/or vascular dementia demonstrate specific difficulties in dual-task situations. In this context, the investigators hypothesize that the continuous alternation between maintenance and processing phases involved in working memory could be impaired for these patients. Thus, the aim of the present study is to investigate if patients with Alzheimer's disease and/or vascular dementia can use maintenance strategies of information in working memory, as typically observed in individuals without cognitive impairments.
To this end, the investigators propose a short working memory task in which they manipulate the opportunities to use refreshing strategies and elaborative strategies. The investigators expect that patients with Alzheimer's disease, vascular dementia, or mixed dementia will benefit less than healthy older adults from the increased opportunities to employ refreshing and elaboration. These difficulties could account for the impaired working memory performance associated with these diseases.
In a second step, the investigators formulate distinctive hypotheses between patient sub-groups:
- On the one hand, Alzheimer's disease is characterized by salient impairment of episodic long-term memory. Consequently, the investigators hypothesize that the working memory decline could be related to this deficit in long-term memory. Specifically, patients with Alzheimer's disease would have greater difficulty in implementing elaboration strategies. Thus, these patients' recall performance should benefit less from semantic links between the to-be-remembered items compared to patients with vascular dementia.
- On the other hand, vascular dementia is characterized by a significant impairment of executive functioning. Thus, the investigators hypothesize that the working memory decline could be related to difficulties in implementing refreshing strategies (i.e., voluntary control of attention). Thus, the recall performance of these patients should benefit less from increased free time during the task, compared to patients with Alzheimer's disease.
- Finally, very few studies have been carried out on patients with mixed dementia (from both Alzheimer's disease and vascular dementia). The investigators assume that the recall performance of these patients will benefit less from elaborative opportunities compared to patients with dementia vascular, and less from refreshing opportunities compared to patients with Alzheimer's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease | – | Behavioral: Complex span task, Diagnostic Test: Clinical neuropsychological assessmentAlzheimer's disease is define on the basis of the medical diagnostic. As part of routine care, they undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions. For the study and during the day of medical consultations, each patient will perform a working memory task, lasting approximately 30 minutes. If the patient is accompanied by a family member, the investigators ask the latter to complete a questionnaire on patient's daily executive functioning (French version of the Behavior rating inventory of executive function [BRIEF-A]). |
| Vascular dementia | – | Behavioral: Complex span task, Diagnostic Test: Clinical neuropsychological assessmentVascular dementia is define on the basis of the medical diagnostic. As part of routine care, they undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions. For the study and during the day of medical consultations, each patient will perform a working memory task, lasting approximately 30 minutes. If the patient is accompanied by a family member, the investigators ask the latter to complete a questionnaire on patient's daily executive functioning (French version of the Behavior rating inventory of executive function [BRIEF-A]). |
| Mixed dementia | – | Behavioral: Complex span task, Diagnostic Test: Clinical neuropsychological assessmentMixed dementia (i.e., Alzheimer's disease and vascular dementia) is define on the basis of the medical diagnostic. As part of routine care, they undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions . For the study and during the day of medical consultations, each patient will perform a working memory task, lasting approximately 30 minutes. If the patient is accompanied by a family member, the investigators ask the latter to complete a questionnaire on patient's daily executive functioning (French version of the Behavior rating inventory of executive function [BRIEF-A]). |
| Control group | – | Behavioral: Complex span task, Diagnostic Test: Clinical neurospychological assessementControl group includes healthy older adults (without cognitive impairment). As patient group, control group will perform the working memory task. However, control group does not undergo the clinical neuropsychological assessment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The population of this study will consist of patients performing a neuropsychological assessment at Grenoble-Alpes University Hospital. These patients consult because of cognitive disorders. The patients are dividied into these three subgroups according to their medical diagnosis of Alzheimer's disease, vascular dementia, or mixed dementia (diagnostic criteria : Dubois et al. (2021) for Alzheimer's disease; VASCOG diagnostic criteria : Sachdev et al., 2015 for vascular dementia; and diagnostic criteria : DSM-V (APA, 2013) for mixed dementia due to Alzheimer and vascular etiology). The population of this study will also include healthy participants (carers/visitors of patients at the Gerontology centre or volunteers at Gerontology centre).
Key inclusion criteria (14 listed)
- For patient and control groups: Adults ≥ 65 years of age
- For patient and control groups: Native French speaker
- For patient and control groups: Vision for easy reading
- For patient and control groups: Hearing for easy instruction understanding
- For patient and control groups: Back span ≥ 3 during the "Digit Span Backward" subtest (WAIS-IV)
Key exclusion criteria (8 listed)
- For patient and control groups: People under guardianship or deprived of their freedom
- For patient and control groups: Diagnosis of severe psychiatric disorders
- For patient and control groups: Suspicion of pathologies related to alcohol dependence
- For patient and control groups: No French social security coverage
- For patient and control groups: Refusal to voluntarily participate in this study
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 |
|---|---|---|
| Complex span taskAlso: Working memory taskThe intervention consists in a computerized working memory task. This task follows the design of a complex span task, involving alternation between memorization and processing steps. For each trial, participants have to memorize French words. These words are sequentially displayed on the screen. Between each word, participants perform a processing task consisting in a spatial location task: They have to determine if a shape is at the top or at the bottom of the screen. After each processing episode, participants have a free time (i.e., available time to maintain information in WM). At the end of each trial, participants perform an orally immediate recall. This experimental task involves several conditions in order to manipulate the opportunities for the spontaneous use of refreshing and elaborative strategies. | Behavioural | Alzheimer disease, Control group, Mixed dementia, Vascular dementia |
| Clinical neuropsychological assessmentAs part of routine care, participants in the patient group undergo a standardized clinical neuropsychological assessment that evaluates several cognitive functions. The investigators hypothesize correlations between working memory performance during the experimental task and the results of neuropsychological tests. Thus, the investigators consider the results to several French versions of neuropsychological tests: * MMSE (Mini-Mental State Examination) * "Digit Span Backward" subtest (WAIS-IV) * Stroop Test * Trail Making Test (TMT) * Rappel Libre - Rappel Indicé à 16 items or GERIA-12 * Category fluences * Instrumental Activities of Daily Living and ADL . | Diagnostic test | Alzheimer disease, Mixed dementia, Vascular dementia |
| Clinical neurospychological assessementParticipants in the control group undergo 2 tests clinical that evaluate cognitive functioning. The investigators consider the results to French versions of these neuropsychological tests: * MMSE (Mini-Mental State Examination; ) * "Digit Span Backward" subtest (WAIS-IV) | Diagnostic test | Control group |
Primary outcome
Memory performance in the Working memory task
Time frame: 15 minutes
Percentage of correct immediate recall, computed with strict serial recall criterion (item identity + correct position) and computed with item recall criterion (item identity only).
Processing performance in the Working memory task
Time frame: 15 minutes
Percentage of correct response in the spatial part of working memory task
Reaction time
Time frame: 30 minutes
Reaction time for each distractor (in ms) in the spatial part of working memory task
20 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: 15 minutes
Digit span forward WAIS IV (digit number)
Time frame: 5 minutes
Digit span forward WAIS IV (standard note)
Time frame: 5 minutes
Digit span backward WAIS IV (digit number)
Time frame: 5 minutes
Digit span backward WAIS IV (standard note)
Time frame: 5 minutes
Stroop Test - denomination part
Time frame: 30 secondes
Stroop Test - minor interference part (Time)
Time frame: 30 secondes
Stroop Test - minor interference part (errors)
Time frame: 30 secondes
Stroop Test - major interference part (time)
Time frame: 90 secondes
Stroop Test - major interference part (errors)
Time frame: 90 secondes
Trail Making Test - Part A (time)
Time frame: 2 minutes
Trail Making Test - Part A (errors)
Time frame: 2 minutes
Trail Making Test - Part B (time)
Time frame: 5 minutes
Trail Making Test - Part B (errors)
Time frame: 5 minutes
Category fluences
Time frame: 5 minutes
Memory evaluation (16-item Free and Cued Recall, or GERIA-12)
Time frame: 40 minutes
Naming task
Time frame: 40 minutes
Behavior rating inventory of executive function
Time frame: 10 minutes
Instrumental Activities of Daily Living
Time frame: 5 minutes
Activities of Daily Living
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 29557069Bartsch LM, Singmann H, Oberauer K. The effects of refreshing and elaboration on working memory performance, and their contributions to long-term memory formation. Mem Cognit. 2018 Jul;46(5):796-808. doi: 10.3758/s13421-018-0805-9.
- Background: PubMed 17605579Belleville S, Chertkow H, Gauthier S. Working memory and control of attention in persons with Alzheimer's disease and mild cognitive impairment. Neuropsychology. 2007 Jul;21(4):458-69. doi: 10.1037/0894-4105.21.4.458.
- Background: PubMed 29542133Camos V, Johnson M, Loaiza V, Portrat S, Souza A, Vergauwe E. What is attentional refreshing in working memory? Ann N Y Acad Sci. 2018 Jul;1424(1):19-32. doi: 10.1111/nyas.13616. Epub 2018 Mar 15.
- Background: PubMed 16523997Conway AR, Kane MJ, Bunting MF, Hambrick DZ, Wilhelm O, Engle RW. Working memory span tasks: A methodological review and user's guide. Psychon Bull Rev. 2005 Oct;12(5):769-86. doi: 10.3758/bf03196772.
- Background: PubMed 20543458Inasaridze K, Foley JA, Logie RH, Sala SD. Dual task impairments in vascular dementia. Behav Neurol. 2010;22(1-2):45-52. doi: 10.3233/BEN-2009-0252.
- Background: PubMed 34675799Zheng C, Zhang RS, Wan T, Zhao JS. Topological Alterations of Working Memory Impairment in Aged Patients With Vascular Dementia. Front Aging Neurosci. 2021 Oct 4;13:741445. doi: 10.3389/fnagi.2021.741445. eCollection 2021.
- Background: PubMed 11459742Baddeley AD, Baddeley HA, Bucks RS, Wilcock GK. Attentional control in Alzheimer's disease. Brain. 2001 Aug;124(Pt 8):1492-508. doi: 10.1093/brain/124.8.1492.
- Background: PubMed 8868277Belleville S, Peretz I, Malenfant D. Examination of the working memory components in normal aging and in dementia of the Alzheimer type. Neuropsychologia. 1996 Mar;34(3):195-207. doi: 10.1016/0028-3932(95)00097-6.
- Background: PubMed 24787541Foley JA, Cocchini G, Logie RH, Della Sala S. No dual-task practice effect in Alzheimer's disease. Memory. 2015;23(4):518-28. doi: 10.1080/09658211.2014.908922. Epub 2014 Apr 30.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 21090897Gagnon LG, Belleville S. Working memory in mild cognitive impairment and Alzheimer's disease: contribution of forgetting and predictive value of complex span tasks. Neuropsychology. 2011 Mar;25(2):226-36. doi: 10.1037/a0020919.
- Background: PubMed 24459411Jahn H. Memory loss in Alzheimer's disease. Dialogues Clin Neurosci. 2013 Dec;15(4):445-54. doi: 10.31887/DCNS.2013.15.4/hjahn.
- Individual participant dataSharing planned: No
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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.
Benoit Lemaire study chair
Laboratoire de Psychologie et NeuroCognition
Sophie Portrat study chair
Laboratoire de Psychologie et NeuroCognition
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Vascular Dementia, run by University Hospital, Grenoble.
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 14 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Amelie Bichon (0476728161, abichon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory performance in the Working memory task (time frame: 15 minutes). The study lists 3 primary outcomes in all. 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 NCT06321380, which also lists 27 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 20 Mar 2024.