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Not yet recruiting NCT06993285

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

No phase Interventional Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Protologic and LAnguage adaptation rehabilitation.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other 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

Primary outcome measures

  • Return to communication (YES / NO) during non pharmacological intervention [Time frame: From enrollment to the end of non pharmacological intervention at 34 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CentralHNF — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT06993285 · Central Hospital, Nancy France · Fondation Médéric Alzheimer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗