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

ADvanced ALzheimer Disease and Effects of Protologic and LAnguage Rehabilitation Tools (a Non-pharmacological Intervention) in Nursing Home.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06993285
Acronym
ADALPA
Enrollment
9
Registered
2025-05-28
Start date
2025-06-30
Completion date
2028-12-31
Last updated
2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

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

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.

Interventions

OTHERProtologic 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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Return to communication (YES / NO) during non pharmacological interventionFrom enrollment to the end of non pharmacological intervention at 34 weeksThe 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).

Countries

France

Contacts

Primary ContactLaure JOLY, Professor
l.joly@chru-nancy.fr+33383153307
Backup ContactClotilde Caillet-Gipeaux
clotilde.caillet@orange.fr+33611889619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026