DAPHNE Scale Validation in Frontotemporal Lobar Degeneration

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02889601
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Actual Duration (Months): 34.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frontotemporal Lobar Degeneration	Other: Psycho-behavioural assessment

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 89 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Psycho-behavioral Disorders in Frontotemporal Lobar Degeneration: Validation of a Quantification and Follow-up Scale
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 31, 2013
• Actual Study Completion Date: Dec 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
Fronto-temporal lobar degeneration DAPHNE score building and internal validation through Fronto-temporal lobar degeneration patients.	Other: Psycho-behavioural assessment; DAPHNE Scale
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; DAPHNE Scale

Outcome Measures

Primary Outcome Measures

1. Internal validation of DAPHNE Score [Baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Mini-Mental State Examination ≥ 18

2. Consent

Exclusion Criteria:

• Minor patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France	44000

Sponsors and Collaborators

• Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT02889601
• Other Study ID Numbers: RC12_0463
• First Posted: Sep 5, 2016
• Last Update Posted: Aug 21, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Frontotemporal Lobar Degeneration

Study Results

No Results Posted as of Aug 21, 2017