Clinical trial: ARIADE : Augmented Reality for Improving Autonomy in Dementia (NCT04742465)

Eligibility criteria:
Inclusion Criteria:

          -  Existence of a probable Alzheimer's disease (AD) according to the NIAA criteria
             (McKhann et al., 2011) with a Mini Mental State Examination (MMSE) greater than or
             equal to 20 (threshold defined in order not to include certain participants whose
             comprehension problems would not be compatible with the ARIADE project) OR Existence
             of an Alzheimer-type Mild Cognitive Impairment (MCI) according to the criteria of
             Albert et al. (2011)

          -  Adult person

          -  Affiliation to a social security scheme

          -  Free, informed and signed written consent The diagnosis of dementia or MCI of the
             probable Alzheimer type will be made by the medical and paramedical team of the
             Memory, Resources and Research Center (CMRR) of the Rennes University Hospital
             (Department of Dr Serge Belliard). The proposal for voluntary participation in the
             ARIADE project will be made by one of the project's clinical investigators to CMRR
             patients who have already expressed their interest in participating in a clinical
             research project (list already updated by the CMRR team) and to members of the
             Association Bistrot Mémoire de Rennes, partner of the ARIADE project, after validation
             of the inclusion and non-inclusion criteria by the CMRR team at Rennes University
             Hospital.

        Exclusion Criteria:

          -  Clinical history of neurological event in the central nervous system

          -  Untreated anxiety-depressive syndrome with a sub-score A (anxiety) or D (depression)
             on the HADS questionnaire, i.e. Hospital Anxiety and Depression Scale, greater than or
             equal to 11

          -  Moderate or greater deafness (loss of at least 40dB from the "good" ear) or an
             asymmetry of more than 10dB between the left and right ear on tone audiometry

          -  Insufficient corrected visual acuity (decree of August 31, 2010 for driving a light
             vehicle) (incompatibility if binocular visual acuity is less than 5 / 10th OR if the
             acuity of one eye is less than 1 / 10th and the acuity of the other eye is less than 5
             / 10th)

          -  Severe comprehension disorder, preventing the understanding of the instructions

          -  Severe behavioral disorder, not allowing participation in the experiment (DSM-V)

          -  Acute decompensated pathology (example: heart failure)

          -  Lack of social security

          -  Safeguarding effective justice

          -  Severe balance disorders noted when performing a Timed Up and Go Test with a risk of
             falling noted by the assessor or an inability to perform a 6-minute walk test.

          -  Non-French speaking person

          -  Pregnant or breastfeeding woman

        The existence of a simple curatorship, a reinforced curatorship or a tutorship will not
        constitute a criterion for non-inclusion. Indeed, people with a neurocognitive disorder
        under legal protection are those who probably present the most loss of autonomy and loss of
        social participation and inclusion in the city, in connection with the disease and / or
        with isolation. social and family. These are therefore the people most in need of
        technological aids that we are going to offer. It therefore seems illogical to exclude them
        insofar as they will represent the sub-part of this population that will need them the most
        and will probably derive great benefit from them, with minimal risks in this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment