NCT03606798

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

July 20, 2018

Last Update Submit

March 30, 2022

Conditions

Frontotemporal Lobar Degeneration

Keywords

Frontotemporal Lobar DegenerationBehavioral disorders

Outcome Measures

Primary Outcomes (1)

  • Neuropsychiatric Inventory (NPI)

    Assessment of neuropsychiatric symptomatology

    6 months

Secondary Outcomes (8)

  • Neuropsychiatric Inventory (NPI)

    12 months

  • Mini Mental State Examination

    6 months and 12 months

  • Frontal Behavioral Inventory

    6 months and 12 months

  • Frontal Assessment Battery

    6 months and 12 months

  • Geriatric Depression Scale Score ( From 0 to 30)

    6 months and 12 months

  • +3 more secondary outcomes

Study Arms (2)

Multidisciplinary and personalized care

EXPERIMENTAL

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

Other: 3 Home visits made by a psychologist

Reference care

NO INTERVENTION

Standard clinical evaluations of patient with Frontotemporal Lobar Degeneration.

Interventions

3 Home visits made by a psychologistOTHER

Patient and caregiver interviews with a psychologist at home

Multidisciplinary and personalized care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Bordeaux, 33079, France

Location

MeSH Terms

Conditions

Frontotemporal Lobar DegenerationMental Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive Disorders

Study Officials

  • Jean-François DARTIGUES

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

July 31, 2018

Study Start

June 21, 2018

Primary Completion

October 6, 2021

Study Completion

October 6, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)