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

NCT ID: NCT04010175

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2022-01-25

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

Group Type: ACTIVE_COMPARATOR

Control - Cognitive training in a practitioner's office one time per week

Intervention Type: BEHAVIORAL

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 group 1

Moderate frequency cognitive distance training

Group Type: EXPERIMENTAL

Experimental group 1 - Cognitive training in a practitioner's office one time per week and cognitive distance training one time per week

Intervention Type: BEHAVIORAL

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 group 2

High frequency cognitive distance training

Group Type: EXPERIMENTAL

Experimental group 2 - Cognitive training in a practitioner's office one time per week and cognitive distance training four times per week

Intervention Type: BEHAVIORAL

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Neuropsychologie - Hôpital Neurologique, Hospices Civils de Lyon

Bron, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35725247 (View on PubMed)

Other Identifiers

69HCL18_0881

Identifier Type: -

Identifier Source: org_study_id