Alzheimer DiseaseADALPANCT06993285
ADvanced ALzheimer Disease and Effects of Protologic and LAnguage Rehabilitation Tools in Nursing Home (ADALPA)
A study testing Protologic and LAnguage adaptation rehabilitation in people with Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Protologic and LAnguage adaptation rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ADvanced ALzheimer Disease and Effects of Protologic and LAnguage Rehabilitation Tools (a Non-pharmacological Intervention) in Nursing Home.
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".
Read more
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
- Being tested
- Protologic and LAnguage adaptation rehabilitation
- Keywords
- severe Alzheimer disease, non pharmacological intervention, protologic rehabilitation, speech therapist
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protologic and LAnguage adaptation rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Protologic and LAnguage adaptation rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of non pharmacological intervention at 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laure JOLY, Central Hospital, Nancy, France
- Investigators
- Laure JOLY, Professor, Study director, Central Hospital, Nancy, FranceClotilde Caillet-Gipeaux, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993285
- Sponsor's protocol ID
- Central Hospital, Nancy France
- Other IDs
- Fondation Médéric Alzheimer
- Acronym
- ADALPA
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADvanced ALzheimer Disease and Effects of Protologic and LAnguage Rehabilitation Tools (a Non-pharmacological Intervention) in Nursing Home.
- ClinicalTrials.gov ID
- NCT06993285
- Acronym / sponsor ID
- ADALPA / Central Hospital, Nancy France
- Conditions
- Alzheimer Disease
- Keywords
- severe Alzheimer disease, non pharmacological intervention, protologic rehabilitation, speech therapist
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| return to communication verbally or non-verbally of patients with severe Alzheimer disease | Other | Other: Protologic and LAnguage adaptation rehabilitation9 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protologic and LAnguage adaptation rehabilitationEach 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 | return to communication verbally or non-verbally of patients with severe Alzheimer disease |
Primary outcome
Return to communication (YES / NO) during non pharmacological intervention
Time frame: From enrollment to the end of non pharmacological intervention at 34 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laure JOLY, Professor study director
Central Hospital, Nancy, France
Clotilde Caillet-Gipeaux principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protologic and LAnguage adaptation rehabilitation in people with Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure JOLY, Professor (+33383153307, l.joly@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to communication (YES / NO) during non pharmacological intervention (time frame: From enrollment to the end of non pharmacological intervention at 34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.