DAPHNE Scale Validation in Frontotemporal Lobar Degeneration

Completed

• Conditions: Frontotemporal Lobar Degeneration
• Interventions: Other: Psycho-behavioural assessment

• Registration Number: NCT02889601
• Lead Sponsor: Nantes University Hospital

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-12-31
• Study Completion: 2015-12-31
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

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Exclusion Criteria

• Minor patient

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fronto-temporal lobar degeneration	Psycho-behavioural assessment	DAPHNE score building and internal validation through Fronto-temporal lobar degeneration patients.
Control	Psycho-behavioural assessment	External validation of DAPHNE score among patients with Alzheimer's disease, progressive supranuclear palsy and bipolar disorder with cognitive disorders.

Primary Outcome Measures

Name	Time	Method
Internal validation of DAPHNE Score	Baseline	Face validity - Structural validity - Convergent Validity - Known-groups validity - Responses consistency - Reliability

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France