NCT06321380

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

February 5, 2024

Last Update Submit

March 18, 2024

Conditions

Keywords

Working memoryAlzheimer diseaseVascular dementiaMixed dementiaComplex span task

Outcome Measures

Primary Outcomes (3)

  • 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).

    15 minutes

  • Processing performance in the Working memory task

    Percentage of correct response in the spatial part of working memory task

    15 minutes

  • Reaction time

    Reaction time for each distractor (in ms) in the spatial part of working memory task

    30 minutes

Secondary Outcomes (20)

  • Mini-Mental State Examination (MMSE)

    15 minutes

  • Digit span forward WAIS IV (digit number)

    5 minutes

  • Digit span forward WAIS IV (standard note)

    5 minutes

  • Digit span backward WAIS IV (digit number)

    5 minutes

  • Digit span backward WAIS IV (standard note)

    5 minutes

  • +15 more secondary outcomes

Study Arms (4)

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 \[BRIEF-A\]).

Behavioral: Complex span taskDiagnostic 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 \[BRIEF-A\]).

Behavioral: Complex span taskDiagnostic 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 \[BRIEF-A\]).

Behavioral: Complex span taskDiagnostic 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.

Behavioral: Complex span taskDiagnostic Test: Clinical neurospychological assessement

Interventions

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.

Also known as: Working memory task
Alzheimer diseaseControl groupMixed dementiaVascular dementia

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 .

Alzheimer diseaseMixed dementiaVascular dementia

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)

Control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (27)

  • 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.

    PMID: 29557069BACKGROUND
  • Belleville 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.

    PMID: 17605579BACKGROUND
  • Camos 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.

    PMID: 29542133BACKGROUND
  • Conway 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.

    PMID: 16523997BACKGROUND
  • Inasaridze 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.

    PMID: 20543458BACKGROUND
  • Zheng 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.

    PMID: 34675799BACKGROUND
  • Baddeley 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.

    PMID: 11459742BACKGROUND
  • Belleville 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.

    PMID: 8868277BACKGROUND
  • Foley 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.

    PMID: 24787541BACKGROUND
  • Folstein 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.

    PMID: 1202204BACKGROUND
  • Gagnon 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.

    PMID: 21090897BACKGROUND
  • Jahn H. Memory loss in Alzheimer's disease. Dialogues Clin Neurosci. 2013 Dec;15(4):445-54. doi: 10.31887/DCNS.2013.15.4/hjahn.

    PMID: 24459411BACKGROUND
  • Jellinger 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.

    PMID: 21504129BACKGROUND
  • KATZ 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.

    PMID: 14044222BACKGROUND
  • Korczyn 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.

    PMID: 22575403BACKGROUND
  • Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

    PMID: 5349366BACKGROUND
  • McGuinness B, Barrett SL, Craig D, Lawson J, Passmore AP. Executive functioning in Alzheimer's disease and vascular dementia. Int J Geriatr Psychiatry. 2010 Jun;25(6):562-8. doi: 10.1002/gps.2375.

    PMID: 19810010BACKGROUND
  • O'Brien JT, Thomas A. Vascular dementia. Lancet. 2015 Oct 24;386(10004):1698-706. doi: 10.1016/S0140-6736(15)00463-8.

    PMID: 26595643BACKGROUND
  • Raoux N, Le Goff M, Auriacombe S, Dartigues JF, Amieva H. [Semantic and letter fluency tasks: normative data in an elderly population of 70 years old and over from the PAQUID cohort]. Rev Neurol (Paris). 2010 Jun-Jul;166(6-7):594-605. doi: 10.1016/j.neurol.2010.01.012. Epub 2010 Mar 16. French.

    PMID: 20236672BACKGROUND
  • Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. doi: 10.1016/S0887-6177(03)00039-8.

    PMID: 15010086BACKGROUND
  • Vandenberghe M, Michiels J, Vanderaspoilden V, Claes T, Fery P. [Creation and normalisation of a verbal episodic memory task in elderly adults: "GERIA-12"]. Rev Neurol (Paris). 2015 Dec;171(12):853-65. doi: 10.1016/j.neurol.2015.08.001. Epub 2015 Nov 10. French.

    PMID: 26563664BACKGROUND
  • Vergauwe E, Ricker TJ, Langerock N, Cowan N. What do people typically do between list items? The nature of attention-based mnemonic activities depends on task context. J Exp Psychol Learn Mem Cogn. 2019 May;45(5):779-794. doi: 10.1037/xlm0000625. Epub 2018 Jul 19.

    PMID: 30024250BACKGROUND
  • Roy, A., Fournet, N., Le Gall, D., Roulin, J. L. BRIEF. Inventaire d'évaluation comportementale des fonctions exécutive - Adaptation française. Hogrèfe France Editions (2014).

    BACKGROUND
  • Logie, R., Camos, V., & Cowan, N. Working memory: State of the science. Oxford University Press. (2020).

    BACKGROUND
  • Grober E., & Buschke H. . Genuine memory deficits in dementia. Developmental Neuropsychology,(1987) 5, 13-36.

    BACKGROUND
  • Craik, F. I. M., & Tulving, E. Depth of processing and the retention of words in episodic memory. Journal of Experimental Psychology (1975). General, 104, 268-294.

    BACKGROUND
  • Bayard, S., Erkes, J., & Moroni, C. (2009). Test du Stroop Victoria-Adaptation Francophone. CPCN-LR, Gignac.

    BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementia, VascularMixed Dementias

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Benoit Lemaire

    Laboratoire de Psychologie et NeuroCognition

    STUDY CHAIR
  • Sophie Portrat

    Laboratoire de Psychologie et NeuroCognition

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

March 20, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share