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CompletedNCT03606798DLFTUpdated Mar 31, 2022

Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.

An interventional study of 3 Home visits made by a psychologist in Frontotemporal Lobar Degeneration, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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

02

Conditions studied

  • Frontotemporal Lobar Degeneration

Keywords

  • Frontotemporal Lobar Degeneration
  • Behavioral disorders
03

In context

Frontotemporal Lobar Degeneration

44 studies on the registry are indexed under Frontotemporal Lobar Degeneration; 12 are open to participants now.

This study's enrollment of 38 is below the median of 72 across 21 interventional studies indexed under Frontotemporal Lobar Degeneration.

Browse Frontotemporal Lobar Degeneration studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Multidisciplinary and personalized care

    Personalized care and proposals bring by a team of experts : neurologists ; geriatrician ; psychologist.

    Other: 3 Home visits made by a psychologist

  • No intervention
    Reference care

    Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration.

Interventions

  • Other3 Home visits made by a psychologist

    Patient and caregiver interviews with a psychologist at home

06

What researchers measure

Primary outcomes

  1. Neuropsychiatric Inventory (NPI)

    Assessment of neuropsychiatric symptomatology

    Time frame: 6 months

Secondary outcomes

  1. Neuropsychiatric Inventory (NPI)

    Assessment of neuropsychiatric symptomatology

    Time frame: 12 months

  2. Mini Mental State Examination

    Time frame: 6 months and 12 months

  3. Frontal Behavioral Inventory

    Time frame: 6 months and 12 months

  4. Frontal Assessment Battery

    Time frame: 6 months and 12 months

  5. Geriatric Depression Scale Score ( From 0 to 30)

    Score : 0 - 5 : normal Score : 5 - 9 : light depression Score : 10 - 30 : severe depression

    Time frame: 6 months and 12 months

  6. Sense of Competence Questionnaire (SCQ)

    Time frame: 6 months and 12 months

  7. Quality of Life Questionnaire (QoL-AD)

    Time frame: 6 months and 12 months

  8. 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

    Time frame: 6 months and 12 months

07

Study locations

1 site
  • Bordeaux University Hospital
    Bordeaux, 33079, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03606798
Responsible party
Sponsor
First posted
Jul 31, 2018
Start date
Jun 21, 2018
Primary completion
Oct 6, 2021
Completion
Oct 6, 2021
Last update
Mar 31, 2022

Study contacts

Jean-François DARTIGUES
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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