Clinical trial NCT04113577: COgilus Remediation in Alzheimer Patients (CORA)
Official title: COgilus Remediation in Alzheimer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Satisfaction
Neurocognitive Disorders
Keywords: old people
elderly
minor neurocognitive disorder
major neurocognitive disorder
neurocognitive disorder
mild cogntitive impairment
MCI
alzheimer disease
app
usability
ergonomic
satisfaction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited during their complet or day hospitalisation in geriatric medicine.

Relatives / unformal caregivers are recruited during the hospitalisation of patients in geriatric medicine. Professionnal caregivers are recruited in the acute care geriatric unit or in the day hospitalisation geriatric unit.

Brief summary: This study evaluates the usability of a new tablet PC application to stimulate cognitive functions. Patients hospitalized in a geriatric ward (day or complete hospitalisation) but also their informal and professional caregivers will assess the usability of the application using a structured survey.

Detailed description: Attention span is one of the most frequently and early impaired cognitive functions during aging, especially in neurocognitive disorders such as Alzheimer's disease. Decline of attention span can lead to a cognitive complaint by the patient or his or her relatives, even in the prodromal phase of the disease (DSM V: minor neurocognitive disorder). The current challenge is to develop strategies to prevent the cognitive decline in patients with minor neurocognitive disorder or major cognitive disorder with slight impairment, and thus to limit cognitive decline. However, to date, no strategy has shown clear effectiveness in preventing cognitive decline in patients with neurocognitive disorder.

Interestingly, the integration of perceptual skills are modified in patients with neurocognitive disorders, and in particular visuomotor skills (from early stages). Measurements of evoked potientials during visual stimulation in patients with minor neurocognitive disorder have shown a preservation of sensory responses but a decrease in cognitive responses. Based on this observation, a US team had recently tested the effectiveness of computer-based visual cognitive exercises performed regularly for 8 weeks in patients free of major neurocognitive disorder. They had reported an improvement in information processing speed and walking performance. These results suggest that regular cognitive stimulation exercises using tablet PC visual exercices could improve attention span and in particular the information processing speed in patient with minor or early major neurocognitive disorder.

In particular, Cogilus, a cross-platform tablet PC application (Android, iOS, Microsoft) has recently been developed for this purpose. The Cogilus project, is designed for health professionals who support patients with neurological syndromes including cognitive or attentional dysfunctions. The application is also open to carers and family members, who will be able to support the patient in using the application (based on the exercices proposed by professionals).

The finale objective of the Cogilus project is to assess the impact of the regular use of Cogilus on patient with minor or early major neurocognitive disorder. Considering the specific needs in usability for this population, the first step to devoloppe such technology is to assess the usability of the application in patients but also in unformal and professional cargivers.

Eligibility criteria: Inclusion Criteria:

* no opposition to be part of the study
* patients:
* over 65 years old
* to be hospitalised in geriatric medicine department of Angers University Hospital
* mild cognitive impairment (winblad criterion) or minor neurocognitive disorder du to alzheimer disease or early major neurocognitive disorder du to alzheimer disease (DSM V and NINCDS-ADRDA criterion)
* unformal cargivers and health profesionnals:
* over 18 years old

Exclusion Criteria:

* depression (geriatric depression scale 15 items: over 10/15)
* delirum (assessed with the confusion assessment methode)
* to be under legal protection

Primary outcomes:
measure: Usability regarding the Cogilus app
timeFrame: after 30 minutes of test of the app
Secondary outcomes:
measure: Satisfaction regarding the Cogilus app
timeFrame: after 30 minutes of test of the app
measure: Global ergonomics regarding the Cogilus app
timeFrame: after 30 minutes of test of the app
measure: Ergonomics regarding the exercices proposed in the Cogilus app
timeFrame: after 30 minutes of test of the app
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: Angers University Hospital
name: Cedric ANNWEILER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: