Clinical trial NCT06993285: ADvanced ALzheimer Disease and Effects of Protologic and LAnguage Rehabilitation Tools in Nursing Home (ADALPA)
Official title: ADvanced ALzheimer Disease and Effects of Protologic and LAnguage Rehabilitation Tools (a Non-pharmacological Intervention) in Nursing Home.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: severe Alzheimer disease
non pharmacological intervention
protologic rehabilitation
speech therapist
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Background:

During Alzheimer's disease when cognitive disorders become too severe, language and communication are no longer present and/or mobilizable, and as a consequence there is a frequent discontinuation of Care and morever speech therapy rehabilitation. On this very specific subject of return to communication of patients suffering from very advanced Alzheimer's disease with cessation of communication, no data is currently avalable in the scientific literature to identify and define a "threshold for return to communication".

Objectives :

This study aims at obtaining a return to communication verbally (V) or non-verbally (NV), of patients living in nursing home suffering from severe neurocognitive disorders during Alzheimer disease using evaluation grids of V and NV communication.

Secondary objectives are the evaluation of recovery of a relationship with objects, quality of relashionship between patients and caregivers and family members , reduction in behavioral signs ( NPI-ES, EPADE survey), improved nutrition.

Method :

9 patients over 60 years old with major neurocognitive disorders at an advanced stage, presenting behavioral disorders, no longer communicating, interacting and having little or no relationship with objects, with stereotyped behavior or apathy living in 3 nursing home will be recruted during 36 months.

Each patient will receive a maximum of 34 weeks of Protologic and LAnguage adaptation rehabilitation by a speech therapist at a rate of one or two speech therapy sessions per week, for a total of 30 sessions maximum. All sessions are filmed and at posteriori analysed with the help of ELAN© software.

Attended results : The benefits of this research will be to objectivize an improvement in the cognitive state of patients, with a possible return to communication. Moreover, this study will provide a better understanding of neurocognitive disorders and their evolution after a Non-Pharmacological Intervention. The existence of improvements will also enable a change in the way caregivers and relatives look at these patients at an advanced stage, especially as at present, follow-up is generally discontinued as soon as language and communication are no longer present and can not be mobilized.


Eligibility criteria: Inclusion Criteria:

* subject aged ≥60 years
* living in nursing home
* presenting a neurocognitive disorder at an advanced stage
* MMSE \<10
* NPI ES : presence of apathy and/or indifference and/or aberrant motor behavior
* subject having received oral information and representative having received complete information on the organization of the research and not having objected to the participation of the patient and to the exploitation of data
* Subject or representative having consented to the fixation, reproduction and exploitation of the audiovisual recording.

Exclusion Criteria:

* Delirium
* psychiatric disorder (diagnosed severe depressive disorder, diagnosed schizophrenia)
* Personnes benefiting from another non-pharmacological intervention or included in another research protocol
* subject deprived of liberty by a judicial or administrative decision

Primary outcomes:
measure: Return to communication (YES / NO) during non pharmacological intervention
timeFrame: From enrollment to the end of non pharmacological intervention at 34 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CentralHNF
Study officials:
affiliation: Central Hospital, Nancy, France
name: Laure JOLY, Professor
role: STUDY_DIRECTOR
name: Clotilde Caillet-Gipeaux
role: PRINCIPAL_INVESTIGATOR
References: