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Digital Cognitive Remote Training in Alzheimer's Disease (MA-EIAD) (DCRT-AD)

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control - Cognitive training in a practitioner's office one time per week
Experimental group 1 - Cognitive training in a practitioner's office one time per week and cognitive distance training one time per week
Experimental group 2 - Cognitive training in a practitioner's office one time per week and cognitive distance training four times per week
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease focused on measuring Cognitive training, Distance training, Alzheimer's disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 years old or more
  • native French speaker
  • Diagnosis of Alzheimer's disease according DMS-V criteria
  • early to moderate stage of the disease (MMSE > 15)
  • psychotropic drug treatment without change for three months at least
  • signed informed consent
  • being affiliated to a social security

Exclusion Criteria:

  • not corrected visual or auditory deficit
  • motor deficits preventing experimental tests execution
  • ongoing participation in cognitive training or stimulation for more than three months
  • not having a computer at the place of residence
  • refusal of participation
  • being under guardianship

Sites / Locations

  • Service de Neuropsychologie - Hôpital Neurologique, Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

Experimental group 1

Experimental group 2

Arm Description

Moderate frequency cognitive distance training

High frequency cognitive distance training

Outcomes

Primary Outcome Measures

Influence of the training on experimental tasks
To evaluate benefits of cognitive training the scores of four experimental tasks will be combined. Stop Signal - inhibition score range 0 to 24, the higher values indicating better outcomes Updating Span - range 0 to 12, the higher values indicating better outcomes Letter-Number Pairs - flexibility score range 0 to 33, the higher values indicating better outcomes Operating Span - range 0 to 8, the higher values indicating better outcomes
Influence of the training on neuropsychological tests
To evaluate benefits of cognitive training the scores of five neuropsychological tests will be combined. Verbal Fluency - for letter P and animals, 0 to no limits; the higher values indicating better outcomes Trial Making Test A and B - reaction time in ms - the higher values indicating worse outcomes; number of errors - the higher values indicating better outcomes Logical Stories (MEM IV) - immediate memory score (0 to 53); - delayed memory score (0 to 50); - recognition score (0 to 30); the higher values indicating better outcomes. Mini mental State Examination (MMSE) - score from 0 to 30 (higher values indicating better outcomes) Verbal span (Wechsler Adult Intelligence Scale) - forward from 0 to 9 and backward from 0 to 8, the higher values indicating better outcomes
Influence of the training on global quality of life
To evaluate benefits of cognitive training scores of 6 questionnaires will be combined. Geriatric Depression Scale-0 to 30 (lower values indicating better outcomes) Questionnaire of Cognitive Complaint-0 to 10, higher values indicating worse outcomes Instrumental Activities of Daily Living-8 to 31, higher values indicating lower outcomes Pittsburgh Sleep Quality Index-0 (no difficulty) to 3(severe difficulty). Total score (summed)=0 to 21 (higher values indicating worse outcomes) SF-12 (questionnaire of quality of life) Motivational Scale for Older Adults-6 subscales of activities: Health; Related to biological needs ; Related to relationships with others; Related to religion; Related to leisure; Related to Information; For each subscales 4 motivation scores : 1) Extrinsic (0 to 21); 2) Amotivation (0 to 21); 3) Extrinsic - non self-detremined (0 to 21); 4) Intrinsic (0 to 21) The higher values indicating the higher level of each type of motivation/amotivation.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2019
Last Updated
February 16, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04010175
Brief Title
Digital Cognitive Remote Training in Alzheimer's Disease (MA-EIAD)
Acronym
DCRT-AD
Official Title
Cognitive Training in Early to Moderate Stages Alzheimer's Disease Patients: Contribution of Digital Remote Training
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment stopped for thesis defense. It was not possible to extend the period of inclusion to achieve the patient objective
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cerebral functioning changes with age in order to respond to the impacts of different external and internal factors on the brain, and more generally on the human body. Scaffolding Theory of Aging and Cognition proposes that during life the brain develops specific neural networks to handle with cognitive activities. When these networks are impaired due to factors that damage brain structure and/or brain functioning, the brain adapts and elaborates new networks to cope with this situation. A cognitive reserve built throughout life and an appropriated care such as for example cognitive training, are in the centre of this model because they are involved in building these networks. In general, studies exploring cognitive training in normal aging and in patients suffering from neurodegenerative disease such as Alzheimer's disease have shown some benefits of the training on cognitive functioning. It has been shown not only that the cognitive training improves older adults' cognition, but also that these effects last for a long time and positively influence older people everyday activities. In fact, the benefits from memory training were observed 5 years after the end of the training and those of reasoning and of speed of processing even after 10 years. In addition, majority of the participants declared to notice improvement of their everyday life. Concerning Alzheimer's disease, several studies have observed positive results of cognitive training although there are some controversies about its' effects. Numerous studies point out that for cognitive training being the most efficient, the intervention has to take place as early as possible, preferentially in a premorbid stage of the disease and that it is important to propose trainings that minimize the withdrawal. In this sense, the importance of using computer based training was put forward because it allows the elaboration of multiple exercises with playful aspect and more importantly it can adapt on line the difficulty of the exercises to the patient's performance. However, if it is commonly admitted that computer based training has an important role in physician's, psychologist's or speech therapist's office less is known about the efficiency of this type of training performed at distance, at the patient's place of residence. It seems probable that to propose distance training as an additional training to that performed in a practitioner's office would increase training benefits. To investigators knowledge this was not investigated in a systematic way with Alzheimer's disease patients. The more important advantages of a such additional training are: (1) reduction of patients' travelling, (2) increased flexibility of training scheduling and (3) increased frequency of training sessions per week. Thus, in the present study investigators will examine in a systematic way, whether the distance training, as an additional training to this performed in practitioner's office, brings incremental short- and long-term benefits coming from cognitive training in mild to moderate Alzheimer's disease patients. Investigators second objective is to determine what would be the best frequency per week of such an additional training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Cognitive training, Distance training, Alzheimer's disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Moderate frequency cognitive distance training
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
High frequency cognitive distance training
Intervention Type
Behavioral
Intervention Name(s)
Control - Cognitive training in a practitioner's office one time per week
Intervention Description
Participant will perform 1-hour cognitive computer based training one time per week in a practitioner's office during 4 months (16 weeks of training = 16 hours of training). This training will include 10 short tasks of increasing difficulty. Performance of these tasks involve cognitive functions such as: executive functions, reasoning, auditive, visual and visuo-spatial memory, speed of processing, short-term memory and working memory. Thus the training aims to exercise all these cognitive functions.
Intervention Type
Behavioral
Intervention Name(s)
Experimental group 1 - Cognitive training in a practitioner's office one time per week and cognitive distance training one time per week
Intervention Description
Participant will perform 1-hour cognitive computer based training one time per week in a practitioner's office and one time per week cognitive distance training in her/his place of residence, during 4 months (16 weeks of training = 32 hours of training).
Intervention Type
Behavioral
Intervention Name(s)
Experimental group 2 - Cognitive training in a practitioner's office one time per week and cognitive distance training four times per week
Intervention Description
Participant will perform 1-hour cognitive computer based training one time per week in a practitioner's office and four times per week cognitive distance training in her/his place of residence during 4 months (16 weeks of training = 80 hours of training).
Primary Outcome Measure Information:
Title
Influence of the training on experimental tasks
Description
To evaluate benefits of cognitive training the scores of four experimental tasks will be combined. Stop Signal - inhibition score range 0 to 24, the higher values indicating better outcomes Updating Span - range 0 to 12, the higher values indicating better outcomes Letter-Number Pairs - flexibility score range 0 to 33, the higher values indicating better outcomes Operating Span - range 0 to 8, the higher values indicating better outcomes
Time Frame
8 months
Title
Influence of the training on neuropsychological tests
Description
To evaluate benefits of cognitive training the scores of five neuropsychological tests will be combined. Verbal Fluency - for letter P and animals, 0 to no limits; the higher values indicating better outcomes Trial Making Test A and B - reaction time in ms - the higher values indicating worse outcomes; number of errors - the higher values indicating better outcomes Logical Stories (MEM IV) - immediate memory score (0 to 53); - delayed memory score (0 to 50); - recognition score (0 to 30); the higher values indicating better outcomes. Mini mental State Examination (MMSE) - score from 0 to 30 (higher values indicating better outcomes) Verbal span (Wechsler Adult Intelligence Scale) - forward from 0 to 9 and backward from 0 to 8, the higher values indicating better outcomes
Time Frame
8 months
Title
Influence of the training on global quality of life
Description
To evaluate benefits of cognitive training scores of 6 questionnaires will be combined. Geriatric Depression Scale-0 to 30 (lower values indicating better outcomes) Questionnaire of Cognitive Complaint-0 to 10, higher values indicating worse outcomes Instrumental Activities of Daily Living-8 to 31, higher values indicating lower outcomes Pittsburgh Sleep Quality Index-0 (no difficulty) to 3(severe difficulty). Total score (summed)=0 to 21 (higher values indicating worse outcomes) SF-12 (questionnaire of quality of life) Motivational Scale for Older Adults-6 subscales of activities: Health; Related to biological needs ; Related to relationships with others; Related to religion; Related to leisure; Related to Information; For each subscales 4 motivation scores : 1) Extrinsic (0 to 21); 2) Amotivation (0 to 21); 3) Extrinsic - non self-detremined (0 to 21); 4) Intrinsic (0 to 21) The higher values indicating the higher level of each type of motivation/amotivation.
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 years old or more native French speaker Diagnosis of Alzheimer's disease according DMS-V criteria early to moderate stage of the disease (MMSE > 15) psychotropic drug treatment without change for three months at least signed informed consent being affiliated to a social security Exclusion Criteria: not corrected visual or auditory deficit motor deficits preventing experimental tests execution ongoing participation in cognitive training or stimulation for more than three months not having a computer at the place of residence refusal of participation being under guardianship
Facility Information:
Facility Name
Service de Neuropsychologie - Hôpital Neurologique, Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35725247
Citation
Dimachki S, Tarpin-Bernard F, Croisile B, Chainay H. Study design and protocol of a low to high intensity computer-based cognitive training at home in supplement to standard care in patients with AD. BMJ Open. 2022 Jun 20;12(6):e050993. doi: 10.1136/bmjopen-2021-050993.
Results Reference
derived

Learn more about this trial

Digital Cognitive Remote Training in Alzheimer's Disease (MA-EIAD)

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