NCT04606953

Brief Summary

Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia but do not meet the criteria for dementia. Cognitive rehabilitation makes it possible to compensate, at least in part, for cognitive deficits with the ultimate goal of reducing their impact in everyday life. The objective of the research is to evaluate the short- and long-term effectiveness and generalization of an attention and working memory training program (APT-II) on cognition and ecological activities in MCI patients with a randomized controlled trial. Thirty MCI patients will be randomly assigned between a "cognitive training with APT-II" condition and a control (routine care) condition. The intervention will consist of an 8-week individual cognitive training program (2 sessions/week), training different attentional components and working memory. This has the advantage of insisting on the transfer of the acquired knowledge in sessions to daily activities. To evaluate the effectiveness of the treatment, cognitive and functional follow-up measures (including a virtual reality task) are administered at several time intervals. This project should contribute to better management of cognitive disorders by offering a new standardized rehabilitation tool in French to clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.5 years

First QC Date

July 16, 2020

Last Update Submit

September 28, 2021

Conditions

Keywords

mild cognitive impairmentAlzheimer's diseasememory impairmentworking memory trainingcognitive rehabilitationAging

Outcome Measures

Primary Outcomes (20)

  • Mini Mental State MMSE

    The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.

    Prior the program

  • Mini Mental State MMSE

    The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.

    Immediately after the program

  • Mini Mental State MMSE

    The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.

    3 months follow-up

  • Mini Mental State MMSE

    The mini-mental state (MMS) or mini-mental state examination (MMSE) or Folstein test is a test for the evaluation of global cognitive functions. This test is used for diagnostic purposes when there is a suspicion of dementia and cognitive disorders. It evaluates temporospatial orientation, memory, attention, language and praxies. Folstein, Folstein and McHugh, 1975; Greco version.

    6 months follow-up

  • Digit span

    The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001

    Prior the program

  • Digit span

    The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001

    Immediately after the program

  • Digit span

    The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001

    3 months follow-up

  • Digit span

    The Digit span task is a test evaluating the phonological loop and executive control capabilities of the working memory. The test consists of hearing a series of numbers orally by the examiner and must repeat the same series in the same order or in reverse. This test measures the limited capabilities of a specialized verbal short-term memory system described by Baddeley and Hitch (1974). WAIS-III Weschler,2000 and MEM-III Weschler 2001

    6 months follow-up

  • PASAT (Naegele and Mazza, 2004)

    PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.

    Prior the program

  • PASAT (Naegele and Mazza, 2004)

    PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.

    Immediately after the program

  • PASAT (Naegele and Mazza, 2004)

    PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.

    3 months follow-up

  • PASAT (Naegele and Mazza, 2004)

    PASAT is a test that evaluates information processing skills, sustained attention, and shared attention. The individual hears numbers in succession with an interval of 4 seconds. He must add the last digit heard to the last given without losing his attention.

    6 months follow-up

  • Brown Peterson's Paradigm (Peterson and Peterson, 1959)

    Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.

    Prior the program

  • Brown Peterson's Paradigm (Peterson and Peterson, 1959)

    Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.

    Immediately after the program

  • Brown Peterson's Paradigm (Peterson and Peterson, 1959)

    Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.

    3 months follow-up

  • Brown Peterson's Paradigm (Peterson and Peterson, 1959)

    Experimental technique to study forgetting in short-term memory and also used as a measure of the central administrator of working memory. The task is to present the subjects with sequences of three consonants. After the presentation of each sequence, the subject is asked to either perform an immediate recall of the consonants or to perform a countdown task from 30 seconds, 20 seconds or 10 seconds. At the end of this count, the subject must give the series again starting from 3 consonants.

    6 months follow-up

  • Virtual reality memory task

    A developed virtual reality task was also administered to the participants to allow a more ecological analysis of episodic memory and divided attention.

    Prior the program

  • Virtual reality memory task

    A developed virtual reality task was also administered to the participants to allow a more ecological analysis of episodic memory and divided attention.

    Immediately after the program

  • Continious Performance task CPT

    CPT is a task of sustained and selective attention on the computer. The task consists of clicking on the space bar of the computer when a letter is presented on the screen except for the letter "X". The person should not click if they see the letter "X" presented. This test takes several minutes.

    Prior the program

  • Continious Performance task CPT

    CPT is a task of sustained and selective attention on the computer. The task consists of clicking on the space bar of the computer when a letter is presented on the screen except for the letter "X". The person should not click if they see the letter "X" presented. This test takes several minutes.

    Immediately after the program

Secondary Outcomes (12)

  • Cognitive Failure Questionnaire

    Prior the program

  • Cognitive Failure Questionnaire

    Immediately after the program

  • Cognitive Failure Questionnaire

    3 months follow-up

  • Cognitive Failure Questionnaire

    6 months follow-up

  • Bravo's Scale

    Prior the program

  • +7 more secondary outcomes

Study Arms (2)

Attention Process Training (APT-II)

EXPERIMENTAL

Patients in the experimental group receive the APT-II training program (Attention Process Training) individually with a psychologist for 8 weeks (2 sessions/week). The exercises target different attentional components and working memory in the auditory-visual modalities. They are of increasing difficulty while being adapted to each patient's profile in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains towards the most problematic daily activities in order to reduce the impact of the patients' cognitive problems in their daily lives.

Behavioral: Attention Process Training (APT-II)

Standard care

NO INTERVENTION

Patients in the control group receive standard routine care.

Interventions

The exercises target different attentional components and working memory in the auditory-visual modalities. They are of increasing difficulty while being adapted to the profile of each patient in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains to the most problematic daily activities in order to reduce the impact of cognitive disorders in patients' daily life.

Attention Process Training (APT-II)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MCI criteria according to Petersen 2004
  • years and over
  • Native French-speaking or bilingual participant living in the Paris region
  • Normal or corrected vision and hearing
  • Presence of episodic memory and/or attention and/or working memory impairment as evidenced by substandard performance on neuropsychological test(s) evaluating these processes (-1.5 deviations from the norms)

You may not qualify if:

  • Presence of dementia
  • Significant impact of cognitive impairment on activities of daily living requiring external assistance or institutionalization
  • Stroke or brain injury
  • Presence of moderate to severe psychiatric disorders
  • Ethylism
  • General anesthesia in the last six months
  • Treatment directly impacting cognition
  • Patient with significant depression (cut off GDS \> 10)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SABA

Paris, 75020, France

Location

Related Publications (14)

  • Baddeley A, Logie R, Bressi S, Della Sala S, Spinnler H. Dementia and working memory. Q J Exp Psychol A. 1986 Nov;38(4):603-18. doi: 10.1080/14640748608401616. No abstract available.

    PMID: 3809575BACKGROUND
  • Barker-Collo SL, Feigin VL, Lawes CM, Parag V, Senior H, Rodgers A. Reducing attention deficits after stroke using attention process training: a randomized controlled trial. Stroke. 2009 Oct;40(10):3293-8. doi: 10.1161/STROKEAHA.109.558239. Epub 2009 Jul 23.

    PMID: 19628801BACKGROUND
  • Belleville S, Boller B. Comprendre le stade compensatoire de la maladie d'Alzheimer et agir pour promouvoir la cognition et la plasticite cerebrale. Can J Exp Psychol. 2016 Dec;70(4):288-294. doi: 10.1037/cep0000087.

    PMID: 27936842BACKGROUND
  • Blanchet S, McCormick L, Belleville S, Gely-Nargeot MC, Joanette Y. [Mild cognitive impairments in the elderly: a critical review]. Rev Neurol (Paris). 2002 Jan;158(1):29-39. French.

    PMID: 11938320BACKGROUND
  • Kim H, Chey J, Lee S. Effects of multicomponent training of cognitive control on cognitive function and brain activation in older adults. Neurosci Res. 2017 Nov;124:8-15. doi: 10.1016/j.neures.2017.05.004. Epub 2017 Jun 1.

    PMID: 28577979BACKGROUND
  • Palmese CA, Raskin SA. The rehabilitation of attention in individuals with mild traumatic brain injury, using the APT-II programme. Brain Inj. 2000 Jun;14(6):535-48. doi: 10.1080/026990500120448.

    PMID: 10887887BACKGROUND
  • Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.

    PMID: 10190820BACKGROUND
  • Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Author response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Aug 21;91(8):373-374. doi: 10.1212/WNL.0000000000006042. No abstract available.

    PMID: 30126885BACKGROUND
  • Plancher G, Gyselinck V, Piolino P. The Integration of Realistic Episodic Memories Relies on Different Working Memory Processes: Evidence from Virtual Navigation. Front Psychol. 2018 Jan 30;9:47. doi: 10.3389/fpsyg.2018.00047. eCollection 2018.

    PMID: 29441037BACKGROUND
  • Saba M, Blanchet S. [Working memory training in normal and pathological aging: neurocognitive gains and generalization]. Geriatr Psychol Neuropsychiatr Vieil. 2020 Jun 1;18(2):187-195. doi: 10.1684/pnv.2020.0860. French.

    PMID: 32554350BACKGROUND
  • Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.

    PMID: 30103334BACKGROUND
  • Telonio A, Blanchet S, Maganaris CN, Baltzopoulos V, Villeneuve S, McFadyen BJ. The division of visual attention affects the transition point from level walking to stair descent in healthy, active older adults. Exp Gerontol. 2014 Feb;50:26-33. doi: 10.1016/j.exger.2013.11.007. Epub 2013 Nov 27.

    PMID: 24291246BACKGROUND
  • Murray LL, Keeton RJ, Karcher L. Treating attention in mild aphasia: evaluation of attention process training-II. J Commun Disord. 2006 Jan-Feb;39(1):37-61. doi: 10.1016/j.jcomdis.2005.06.001. Epub 2005 Jul 21.

    PMID: 16039661BACKGROUND
  • Unsworth N, Fukuda K, Awh E, Vogel EK. Working memory and fluid intelligence: capacity, attention control, and secondary memory retrieval. Cogn Psychol. 2014 Jun;71:1-26. doi: 10.1016/j.cogpsych.2014.01.003. Epub 2014 Feb 14.

    PMID: 24531497BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseMemory Disorders

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sophie SB Blanchet, Ph.D

    University of Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this single-blind, randomized controlled trial, the follow-up action evaluator is in a blind condition. The evaluator does not know the group to which the participants belong.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In this single-blind, randomized controlled trial, patients are randomly assigned to either a "cognitive training" experimental group (n=15) or a "standard care" control group (n=15).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of these and Associate professor

Study Record Dates

First Submitted

July 16, 2020

First Posted

October 28, 2020

Study Start

February 1, 2019

Primary Completion

July 30, 2021

Study Completion

September 27, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations