Frontotemporal Lobar DegenerationDLFTNCT03606798
Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
A study testing 3 Home visits made by a psychologist in people with Frontotemporal Lobar Degeneration, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Fronto-Temporal Lobar Degeneration (FTLD) refers to 3 categories of neurodegenerative diseases generally occurring between 55 and 65 years: Fronto-Temporal Dementia(FTD), Primary Progressive Aphasia (PPA), Semantic Dementia (SD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Lobar Degeneration
- What is being tested?
- 3 Home visits made by a psychologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2018to 6 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients
- Fronto-Temporal Lobar Degeneration diagnoses
- Men or women aged 18 and over
- Caregiver
- Spouse, brother, sister, child living at patient's home and can provide the medical team of reliable information on the status of their parent.
Who cannot join
- Patient
- Patient institutionalized
- Pregnant or breast-feeding woman
- Psychotic syndrome
- Severe and unstable general medical condition
- Patient bedridden
Show all 10Show fewer
- Caregiver
- Persons under legal protection
- Severe and unstable general medical condition
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Fronto-Temporal Lobar Degeneration (FTLD) refers to 3 categories of neurodegenerative diseases generally occurring between 55 and 65 years: Fronto-Temporal Dementia(FTD), Primary Progressive Aphasia (PPA), Semantic Dementia (SD). Clinical expression is substantially variable among individuals, but in most cases, behavioural disorders and personality changes are prominent. FTLD is poorly known by general public including health care professionals. Currently, the French health system does not meet the needs and expectations of patients and their families
Read the detailed description
Patients with FTLD and their caregivers need to be recognized and supported through specific and tailored made actions provided by expert teams. The main objective of our study is to evaluate the effectiveness of a 6-month personalized multidisciplinary care provided to the dyad FTLD patient and caregiver on patient's behavioural disorders. The secondary objectives are to assess the impact of this program on patient's cognitive deterioration, functional autonomy and behavioral problems, as well as caregiver's depressive symptomatology and sense of competence
- Conditions
- Frontotemporal Lobar Degeneration
- Being tested
- 3 Home visits made by a psychologist
- Keywords
- Frontotemporal Lobar Degeneration, Behavioral disorders
- Medical subject headings
- Frontotemporal Lobar Degeneration, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Home visits made by a psychologistOther
Patient and caregiver interviews with a psychologist at home
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary and personalized care | Experimental | Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist. Receives: Other: 3 Home visits made by a psychologist |
| Reference care | No intervention | Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory (NPI)
Assessment of neuropsychiatric symptomatology
Measured: 6 months
Secondary outcomes (8)
Neuropsychiatric Inventory (NPI)
Assessment of neuropsychiatric symptomatology
Measured: 12 months
Mini Mental State Examination
Measured: 6 months and 12 months
Frontal Behavioral Inventory
Measured: 6 months and 12 months
Frontal Assessment Battery
Measured: 6 months and 12 months
Geriatric Depression Scale Score ( From 0 to 30)
Score : 0 - 5 : normal Score : 5 - 9 : light depression Score : 10 - 30 : severe depression
Measured: 6 months and 12 months
Sense of Competence Questionnaire (SCQ)
Measured: 6 months and 12 months
Quality of Life Questionnaire (QoL-AD)
Measured: 6 months and 12 months
Hierarchical scale of internality for elderly people (EHIPA) score ( From 0 to 22)
The score varies from 0 to 22. A high score corresponding to an important internality
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start21 Jun 2018
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal Lobar DegenerationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François DARTIGUES, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606798
- Sponsor's protocol ID
- CHUBX2015/06
- Acronym
- DLFT
- Status last verified
- Mar 2022
- First submitted
- 20 Jul 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
- ClinicalTrials.gov ID
- NCT03606798
- Acronym / sponsor ID
- DLFT / CHUBX2015/06
- Conditions
- Frontotemporal Lobar Degeneration
- Keywords
- Frontotemporal Lobar Degeneration, Behavioral disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 31 Jul 2018 (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.
Fronto-Temporal Lobar Degeneration (FTLD) refers to 3 categories of neurodegenerative diseases generally occurring between 55 and 65 years: Fronto-Temporal Dementia(FTD), Primary Progressive Aphasia (PPA), Semantic Dementia (SD). Clinical expression is substantially variable among individuals, but in most cases, behavioural disorders and personality changes are prominent. FTLD is poorly known by general public including health care professionals. Currently, the French health system does not meet the needs and expectations of patients and their families
Detailed description
Patients with FTLD and their caregivers need to be recognized and supported through specific and tailored made actions provided by expert teams. The main objective of our study is to evaluate the effectiveness of a 6-month personalized multidisciplinary care provided to the dyad FTLD patient and caregiver on patient's behavioural disorders. The secondary objectives are to assess the impact of this program on patient's cognitive deterioration, functional autonomy and behavioral problems, as well as caregiver's depressive symptomatology and sense of competence
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary and personalized care | Experimental | Other: 3 Home visits made by a psychologistPersonalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist. |
| Reference care | No intervention | –Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients
- Fronto-Temporal Lobar Degeneration diagnoses
- Men or women aged 18 and over
- Caregiver
- Spouse, brother, sister, child living at patient's home and can provide the medical team of reliable information on the status of their parent.
Key exclusion criteria (10 listed)
- Patient
- Patient institutionalized
- Pregnant or breast-feeding woman
- Psychotic syndrome
- Severe and unstable general medical condition
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 |
|---|---|---|
| 3 Home visits made by a psychologistPatient and caregiver interviews with a psychologist at home | Other | Multidisciplinary and personalized care |
Primary outcome
Neuropsychiatric Inventory (NPI)
Time frame: 6 months
Assessment of neuropsychiatric symptomatology
8 secondary outcomes
Neuropsychiatric Inventory (NPI)
Time frame: 12 months
Mini Mental State Examination
Time frame: 6 months and 12 months
Frontal Behavioral Inventory
Time frame: 6 months and 12 months
Frontal Assessment Battery
Time frame: 6 months and 12 months
Geriatric Depression Scale Score ( From 0 to 30)
Time frame: 6 months and 12 months
Sense of Competence Questionnaire (SCQ)
Time frame: 6 months and 12 months
Quality of Life Questionnaire (QoL-AD)
Time frame: 6 months and 12 months
Hierarchical scale of internality for elderly people (EHIPA) score ( From 0 to 22)
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-François DARTIGUES principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 Home visits made by a psychologist in people with Frontotemporal Lobar Degeneration, run by University Hospital, Bordeaux 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 31 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory (NPI) (time frame: 6 months). 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 Mar 2022.