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

NCT06993285 | Not Yet Recruiting

• 2 other identifiers: Central Hospital, Nancy FranceFondation Médéric Alzheimer
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

severe Alzheimer disease; non pharmacological intervention; protologic rehabilitation; speech therapist

Outcome Measures

Primary Outcomes (1)

• Return to communication (YES / NO) during non pharmacological intervention

  The main objective is to authenticate a return to communication (YES / NO) during non pharmacological intervention sessions (maximum 30 sessions per patient) in patients for whom no communication existed at time 0 (each patient is his or her own witness). Authenticate according to the elements obtained from the communication observation grids non-verbal (NV) and verbal (V).

  From enrollment to the end of non pharmacological intervention at 34 weeks

Study Arms (1)

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

OTHER

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.

Other: Protologic and LAnguage adaptation rehabilitation

Interventions

Protologic and LAnguage adaptation rehabilitation 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

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CentralHNF

Vandœuvre-lès-Nancy, 54500, France

Location

Related Links

• 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.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Laure JOLY, Professor

  Central Hospital, Nancy, France

  STUDY DIRECTOR

• Clotilde Caillet-Gipeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure JOLY, Professor

CONTACT

+33383153307; l.joly@chru-nancy.fr

Clotilde Caillet-Gipeaux

CONTACT

+33611889619; clotilde.caillet@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2030
• Access Criteria: Data may be transmitted to companies in the group to which the promoter belongs and to its contractual part All data and information concerning the person taking part in the research will remain strictly confidential. Persons with direct access to these data and information in accordance with the legislative and regulatory provisions in force, in particular articles L.1121-3 and R.5121-13 of the French Public Health Code take all necessary precautions to ensure the confidentiality of information relating to the experimental products, the research, the persons taking part in it and the results obtained. In accordance with article R.5121-13 of the French Public Health Code, these persons may, without the sponsor's consent, provide information relating to research only to the Minister for Health, medical public health inspectors, pharmacist public health inspectors, the Director General and inspectors of the French National Agency for the Safety of Medicines and Health Products.

Locations

FR (1)