- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03606798
Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration. (DLFT)
March 30, 2022 updated by: University Hospital, Bordeaux
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bordeaux, France, 33079
- Bordeaux University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
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.
Exclusion criteria :
Patient
- Patient institutionalized
- Pregnant or breast-feeding woman
- Psychotic syndrome
- Severe and unstable general medical condition
- Patient bedridden
Caregiver
- Persons under legal protection
- Severe and unstable general medical condition
- Pregnant or breast-feeding woman
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multidisciplinary and personalized care
Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist.
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Patient and caregiver interviews with a psychologist at home
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No Intervention: Reference care
Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychiatric Inventory (NPI)
Time Frame: 6 months
|
Assessment of neuropsychiatric symptomatology
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychiatric Inventory (NPI)
Time Frame: 12 months
|
Assessment of neuropsychiatric symptomatology
|
12 months
|
Mini Mental State Examination
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
|
Frontal Behavioral Inventory
Time Frame: 6 months and 12 months
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6 months and 12 months
|
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Frontal Assessment Battery
Time Frame: 6 months and 12 months
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6 months and 12 months
|
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Geriatric Depression Scale Score ( From 0 to 30)
Time Frame: 6 months and 12 months
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Score : 0 - 5 : normal Score : 5 - 9 : light depression Score : 10 - 30 : severe depression
|
6 months and 12 months
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Sense of Competence Questionnaire (SCQ)
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
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Quality of Life Questionnaire (QoL-AD)
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
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Hierarchical scale of internality for elderly people (EHIPA) score ( From 0 to 22)
Time Frame: 6 months and 12 months
|
The score varies from 0 to 22.
A high score corresponding to an important internality
|
6 months and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-François DARTIGUES, University Hospital, Bordeaux
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2018
Primary Completion (Actual)
October 6, 2021
Study Completion (Actual)
October 6, 2021
Study Registration Dates
First Submitted
July 20, 2018
First Submitted That Met QC Criteria
July 20, 2018
First Posted (Actual)
July 31, 2018
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 30, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX2015/06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frontotemporal Lobar Degeneration
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Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedTauopathies | Frontotemporal Dementia (FTD) | Frontotemporal Lobar Degeneration (FTLD)United States
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