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NCT06993285Not yet recruiting

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.

Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
9 (estimated)
First submitted
19 May 2025
Start date
1 Jun 2025
Primary completion date
30 Jun 2028
Lead sponsor
Central Hospital, Nancy, France
NCT number
NCT06993285

What you commit to

  • Study type: Interventional
  • Planned participants: 9
  • From 1 Jun 2025 to the primary completion date, 30 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • psychiatric disorder (diagnosed severe depressive disorder, diagnosed schizophrenia)

Other

  • Delirium
  • Personnes benefiting from another non-pharmacological intervention or included in another research protocol
  • subject deprived of liberty by a judicial or administrative decision

Who the study is looking for

  • 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.

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CentralHNF
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.