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Completed

NCT Number: NCT02889601

DAPHNE Scale Validation in Frontotemporal Lobar Degeneration

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.

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Key information

Conditions

Frontotemporal Lobar Degeneration Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies TDP-43 Proteinopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Minor patient

Treatment and study plan

Psycho-behavioural assessment

Other

DAPHNE Scale

Primary outcomes

  1. Internal validation of DAPHNE Score

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: DAPHNE

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Sep 5, 2016
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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