An interventional study of Protologic and LAnguage adaptation rehabilitation in Alzheimer Disease, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other
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.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 9 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Central Hospital, Nancy, France is the lead sponsor of 796 studies on the registry; 187 are open to participants now.
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Exclusion Criteria:
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
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 (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).
Time frame: From enrollment to the end of non pharmacological intervention at 34 weeks
Plan to share: Yes — Under the responsibility of the promoter or in application of specific legal or regulatory provisions, the categories of persons described below have access to data processed, within the limits of their authorizations with regard to their functions and under conditions that comply with regulations. These categories of persons are bound by professional secrecy under the conditions defined by articles 226-13 and 226-14 of the French penal code. Recipients of indirectly identifying data concerning individuals participating in the research the sponsor and individuals or legal entities acting on its behalf; principal investigators; professionals involved in the research and staff acting under their responsibility or authority (investigator, IRC, CRA, TEC of the investigating center ) staff of companies in the group to which the sponsor belongs and whose participation is necessary for data processing within the framework of the research; healthcare professionals involved
Supporting information: Study protocol, Clinical study report
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.
Start is estimated for Jun 2025; primary completion for Jun 2028, 36 months later.
Of 806 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 36 months is above that.
Counting every sponsor, half of 874 studies reached it within 31 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →