DAPHNE Scale Validation in Frontotemporal Lobar Degeneration

NCT ID: NCT02889601

Last Updated: 2017-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Frontotemporal Lobar Degeneration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fronto-temporal lobar degeneration

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

Psycho-behavioural assessment

Intervention Type OTHER

DAPHNE Scale

Control

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

Psycho-behavioural assessment

Intervention Type OTHER

DAPHNE Scale

Interventions

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Psycho-behavioural assessment

DAPHNE Scale

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC12_0463

Identifier Type: -

Identifier Source: org_study_id

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