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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010175
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Control - Cognitive training in a practitioner's office one time per week Behavioral: Experimental group 1 - Cognitive training in a practitioner's office one time per week and cognitive distance training one time per week Behavioral: Experimental group 2 - Cognitive training in a practitioner's office one time per week and cognitive distance training four times per week Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cognitive Training in Early to Moderate Stages Alzheimer's Disease Patients: Contribution of Digital Remote Training
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : June 28, 2022
Estimated Study Completion Date : June 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group Behavioral: Control - Cognitive training in a practitioner's office one time per week
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.

Experimental: Experimental group 1
Moderate frequency cognitive distance training
Behavioral: Experimental group 1 - Cognitive training in a practitioner's office one time per week and cognitive distance training one time per week
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).

Experimental: Experimental group 2
High frequency cognitive distance training
Behavioral: Experimental group 2 - Cognitive training in a practitioner's office one time per week and cognitive distance training four times per week
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 Measures :
  1. Influence of the training on experimental tasks [ Time Frame: 8 months ]

    To evaluate benefits of cognitive training the scores of four experimental tasks will be combined.

    1. Stop Signal - inhibition score range 0 to 24, the higher values indicating better outcomes
    2. Updating Span - range 0 to 12, the higher values indicating better outcomes
    3. Letter-Number Pairs - flexibility score range 0 to 33, the higher values indicating better outcomes
    4. Operating Span - range 0 to 8, the higher values indicating better outcomes

  2. Influence of the training on neuropsychological tests [ Time Frame: 8 months ]

    To evaluate benefits of cognitive training the scores of five neuropsychological tests will be combined.

    1. Verbal Fluency - for letter P and animals, 0 to no limits; the higher values indicating better outcomes
    2. 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
    3. 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.
    4. Mini mental State Examination (MMSE) - score from 0 to 30 (higher values indicating better outcomes)
    5. Verbal span (Wechsler Adult Intelligence Scale) - forward from 0 to 9 and backward from 0 to 8, the higher values indicating better outcomes

  3. Influence of the training on global quality of life [ Time Frame: 8 months ]

    To evaluate benefits of cognitive training scores of 6 questionnaires will be combined.

    1. Geriatric Depression Scale-0 to 30 (lower values indicating better outcomes)
    2. Questionnaire of Cognitive Complaint-0 to 10, higher values indicating worse outcomes
    3. Instrumental Activities of Daily Living-8 to 31, higher values indicating lower outcomes
    4. Pittsburgh Sleep Quality Index-0 (no difficulty) to 3(severe difficulty). Total score (summed)=0 to 21 (higher values indicating worse outcomes)
    5. SF-12 (questionnaire of quality of life)
    6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010175


Contacts
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Contact: Bernard CROISILE, Dr 04 72 11 80 66 ext +33 bernard.croisile@chu-lyon.fr
Contact: Hanna CHAINAY 04 77 78 43 52 ext +33 hanna.chainay@univ-lyon2.fr

Locations
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France
Service de Neuropsychologie - Hôpital Neurologique, Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Bernard CROISILE, Dr    04 72 11 80 66 ext +33    bernard.croisile@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04010175    
Other Study ID Numbers: 69HCL18_0881
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Cognitive training
Distance training
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders