NCT02889601

Brief Summary

Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a quantification and follow-up scale specifically dedicated to patients with FTD in current clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyper orality, Negligence and loss of Empathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

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

February 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 24, 2016

Last Update Submit

August 16, 2017

Conditions

Frontotemporal Lobar Degeneration

Outcome Measures

Primary Outcomes (1)

  • Internal validation of DAPHNE Score

    Face validity - Structural validity - Convergent Validity - Known-groups validity - Responses consistency - Reliability

    Baseline

Study Arms (2)

Fronto-temporal lobar degeneration

DAPHNE score building and internal validation through Fronto-temporal lobar degeneration patients.

Other: Psycho-behavioural assessment

Control

External validation of DAPHNE score among patients with Alzheimer's disease, progressive supranuclear palsy and bipolar disorder with cognitive disorders.

Other: Psycho-behavioural assessment

Interventions

Psycho-behavioural assessmentOTHER

DAPHNE Scale

ControlFronto-temporal lobar degeneration

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Frontotemporal lobar degeneration according Neary (1998) and Raskowsky (2011) diagnostic criteria.

You may qualify if:

  • Group 1:
  • Patients with FTD according Neary (1998) and Raskowsky (2011) diagnostic criteria.
  • Mini-Mental State Examination ≥ 18
  • Consent
  • Group 2 Control:
  • Patients with Alzheimer's disease (MacKahn, 2011), patients with supranuclear palsy (Litvan, 1996) and patients with bipolar disorder with cognitive disorders.
  • criteria.
  • Mini-Mental State Examination ≥ 18
  • Consent

You may not qualify if:

  • Minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Frontotemporal Lobar Degeneration

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 5, 2016

Study Start

February 1, 2013

Primary Completion

December 31, 2013

Study Completion

December 31, 2015

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

FR(1)