DAPHNE Scale Validation in Frontotemporal Lobar Degeneration

Frontotemporal Lobar Degeneration Clinical Trial

— DAPHNE  

Official title:

Psycho-behavioral Disorders in Frontotemporal Lobar Degeneration: Validation of a Quantification and Follow-up Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889601
• Other study ID #: RC12_0463
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: August 16, 2017
• Start date: February 2013
• Est. completion date: December 31, 2015

Study information

• Verified date: August 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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, Hyperorality, Negligence and loss of Empathy. This study aims to validate this scale. This validation will include methodological steps required to develop a new clinical tool, by studying internal consistency, loyalty, and concurrent validity in comparison with validated existing tools. Complementarily, sensitivity and specificity will be assessed via a control population including patients with Alzheimer's disease, , progressive supranuclear palsy and bipolar disorder with cognitive disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Group 1:

1. Patients with FTD according Neary (1998) and Raskowsky (2011) diagnostic criteria.

2. Mini-Mental State Examination = 18

3. Consent

Group 2 Control:

1. Patients with Alzheimer's disease (MacKahn, 2011), patients with supranuclear palsy (Litvan, 1996) and patients with bipolar disorder with cognitive disorders.

criteria.

2. Mini-Mental State Examination = 18

3. Consent

Exclusion Criteria:

• Minor patient

Related Conditions & MeSH terms

• Frontotemporal Lobar Degeneration

Intervention

Other:
• Psycho-behavioural assessment
DAPHNE Scale

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Internal validation of DAPHNE Score	Face validity - Structural validity - Convergent Validity - Known-groups validity - Responses consistency - Reliability	Baseline