Frontotemporal Lobar DegenerationDAPHNENCT02889601
DAPHNE Scale Validation in Frontotemporal Lobar Degeneration
An observational study of Frontotemporal Lobar Degeneration, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Frontotemporal Lobar Degeneration
- What is being tested?
- Psycho-behavioural assessment
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Frontotemporal lobar degeneration according Neary (1998) and Raskowsky (2011) diagnostic criteria.
Who may be able to join
- 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.
Show all 9Show fewer
- criteria.
- Mini-Mental State Examination ≥ 18
- Consent
Who cannot join
- Minor patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psycho-behavioral Disorders in Frontotemporal Lobar Degeneration: Validation of a Quantification and Follow-up Scale
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.
Read the 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.
- Conditions
- Frontotemporal Lobar Degeneration
- Being tested
- Psycho-behavioural assessment
- Medical subject headings
- Frontotemporal Lobar Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-behavioural assessmentOther
DAPHNE Scale
| Study group | Role | What they receive |
|---|---|---|
| Fronto-temporal lobar degeneration | DAPHNE score building and internal validation through Fronto-temporal lobar degeneration patients. Receives: Other: Psycho-behavioural assessment | |
| Control | External validation of DAPHNE score among patients with Alzheimer's disease, progressive supranuclear palsy and bipolar disorder with cognitive disorders. Receives: Other: Psycho-behavioural assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal validation of DAPHNE Score
Face validity - Structural validity - Convergent Validity - Known-groups validity - Responses consistency - Reliability
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startFeb 2013
- Primary completion31 Dec 2013
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal Lobar DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889601
- Sponsor's protocol ID
- RC12_0463
- Acronym
- DAPHNE
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho-behavioral Disorders in Frontotemporal Lobar Degeneration: Validation of a Quantification and Follow-up Scale
- ClinicalTrials.gov ID
- NCT02889601
- Acronym / sponsor ID
- DAPHNE / RC12_0463
- Conditions
- Frontotemporal Lobar Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fronto-temporal lobar degeneration | – | Other: Psycho-behavioural assessmentDAPHNE score building and internal validation through Fronto-temporal lobar degeneration patients. |
| Control | – | Other: Psycho-behavioural assessmentExternal validation of DAPHNE score among patients with Alzheimer's disease, progressive supranuclear palsy and bipolar disorder with cognitive disorders. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Frontotemporal lobar degeneration according Neary (1998) and Raskowsky (2011) diagnostic criteria.
Key inclusion criteria (9 listed)
- Patients with FTD according Neary (1998) and Raskowsky (2011) diagnostic criteria.
- Mini-Mental State Examination ≥ 18
- Consent
- Patients with Alzheimer's disease (MacKahn, 2011), patients with supranuclear palsy (Litvan, 1996) and patients with bipolar disorder with cognitive disorders.
- criteria.
Key exclusion criteria (1 listed)
- Minor patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-behavioural assessmentDAPHNE Scale | Other | Control, Fronto-temporal lobar degeneration |
Primary outcome
Internal validation of DAPHNE Score
Time frame: Baseline
Face validity - Structural validity - Convergent Validity - Known-groups validity - Responses consistency - Reliability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
Related trials for Frontotemporal Lobar Degeneration
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Enrolling by invitationPhase 2
Alzheimer's Tau Platform: Regimen A - AADvac1
Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frontotemporal Lobar Degeneration, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal validation of DAPHNE Score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.