ADvanced ALzheimer Disease and Effects of Protologic and LAnguage Rehabilitation Tools in Nursing Home (ADALPA)

NCT ID: NCT06993285

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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return to communication verbally or non-verbally of patients with severe Alzheimer disease

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.

Group Type OTHER

Protologic and LAnguage adaptation rehabilitation

Intervention Type OTHER

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

Interventions

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Protologic and LAnguage adaptation rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Laure JOLY

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laure JOLY, Professor

Role: STUDY_DIRECTOR

Central Hospital, Nancy, France

Clotilde Caillet-Gipeaux

Role: PRINCIPAL_INVESTIGATOR

Locations

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CentralHNF

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Central Contacts

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Laure JOLY, Professor

Role: CONTACT

+33383153307

Clotilde Caillet-Gipeaux

Role: CONTACT

+33611889619

Related Links

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https://lnkd.in/eeZ2jbgU

The aims of this project are to improve verbal and non-verbal communication among residents of nursing homes living with advanced Alzheimer's disease and to enable them interaction and communication.

Other Identifiers

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Fondation Médéric Alzheimer

Identifier Type: OTHER

Identifier Source: secondary_id

Central Hospital, Nancy France

Identifier Type: -

Identifier Source: org_study_id

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