Behavioral Variant of Frontotemporal Disorder (bvFTD)NCT06059313
Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders
An observational study of Behavioral Variant of Frontotemporal Disorder (bvFTD) and Phenocopy Frontotemporal Dementia (phFTD), run by Nantes University Hospital at 1 site in France.
Trial summary
Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral Variant of Frontotemporal Disorder (bvFTD), Phenocopy Frontotemporal Dementia (phFTD), Frontal Variant of Alzheimer Disease
- What is being tested?
- Submission of the NEO-PI-3 questionnaire and Submission of the Interpersonal Reactivity Index questionnaire (IRI)
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2023to 14 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted among eligible patients with bvFTD, fvAD, phFTD, followed to Memory Resource and Research Centre at Nantes university Hospital CMRR or referred to the department for a neuropsychological assessment (bipolar disorder). It will prospectively enroll 120 participants.
Who may be able to join
- Patients with behavioral variant of frontotemporal disorder (bvFTD) according to Rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phFTD) who fulfill criteria for possible bvFTD and have no imaging abnormalities or patients with frontal variant of Alzheimer disease according to Ossenkopele criteria (2022), or patient with bipolar disorder according to CIM 10 criteria
- Score for Mini-mental state examination ≥ 18
- Patient with caregiver who has who has known him/her in the 10 years preceding the disease onset.
- Patient and caregiver consents (no opposition)
Who cannot join
- Patient with no caregiver
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes
Claire Bretonnière, PH, 02 40 16 54 22, claire.boutoleaubretonniere@chu-nantes.fr
About this study
Official title: Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders
Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Symptoms vary both quantitatively and qualitatively from disease to another and from person to person. It cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility.
The study will assess the relationship between premorbid profile using NEO-PI 3 inventory and cognitive and behavioral/psychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvFTD), phenocopy frontotemporal dementia (phFTD), frontal variant of Alzheimer disease, bipolar disorder characterized with frontal damages.
- Conditions
- Behavioral Variant of Frontotemporal Disorder (bvFTD), Phenocopy Frontotemporal Dementia (phFTD), Frontal Variant of Alzheimer Disease, Bipolar Disorder
- Being tested
- Submission of the NEO-PI-3 questionnaire, Submission of the Interpersonal Reactivity Index questionnaire (IRI)
- Keywords
- bvFTD, fvAD, phFTD, bipolar disorder,personality
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submission of the NEO-PI-3 questionnaireOther
The questionnaire contains 240 statements. For each statement, the patient chooses the answer that best corresponds to their choice (FD: strongly disagree - D: disagree - N: neutral - A: agree - FA: strongly agree).
Submission of the Interpersonal Reactivity Index questionnaire (IRI)Other
The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral variant of frontotemporal disorder (bvFTD) | A group of participants who fulfill Rascovsky criteria (2011) for behavioural variant Frontotemporal Dementia Receives: Other: Submission of the NEO-PI-3 questionnaire; Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI) | |
| Phenocopy frontotemporal dementia (phFTD) | A group of participants who fulfill who fulfill Rascovsky criteria (2011) for possible behavioural variant Frontotemporal Dementia and have no imaging abnormalities. Receives: Other: Submission of the NEO-PI-3 questionnaire; Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI) | |
| Frontal variant of Alzheimer disease | A group of participants who fulfill Ossenkopele criteria (2022) Receives: Other: Submission of the NEO-PI-3 questionnaire; Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI) | |
| Bipolar disorder | A group of participants who fulfill CIM 10 criteria Receives: Other: Submission of the NEO-PI-3 questionnaire; Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premorbid personality traits
Premorbid personality traits will be assessed by the NEO- NEO Personality Inventory-3 (NEO-PI-3). The NEO PI-3 measures the five major domains of personality: Neuroticism, Extraversion, Openness to experience, Conscientiousness and Agreeableness. Each domain is defined by 6 facets. NEOPI-3 includes 240 items and responses are made on a 5-point Likert -type scale ranging from strongly Disagree to strongly agree. The NEOPI 3 will be completed by a caregiver who has known the patient in the 10 years preceding the disease onset.
Measured: Baseline
Secondary outcomes (1)
Interpersonal Reactivity Index (IRI)
IRI is a 28-item questionnaire measuring 4 aspects of empathy : perspective-taking, fantasy, empathic concern, personal distress. Each answer is rated from 1 (does not describe me well) to 5 (describes me very well).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start14 Dec 2023
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Variant of Frontotemporal Disorder (bvFTD)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059313
- Sponsor's protocol ID
- RC23_0343
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders
- ClinicalTrials.gov ID
- NCT06059313
- Acronym / sponsor ID
- RC23_0343
- Conditions
- Behavioral Variant of Frontotemporal Disorder (bvFTD), Phenocopy Frontotemporal Dementia (phFTD), Frontal Variant of Alzheimer Disease, Bipolar Disorder
- Keywords
- bvFTD, fvAD, phFTD, bipolar disorder,personality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- 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.
Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Symptoms vary both quantitatively and qualitatively from disease to another and from person to person. It cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility.
The study will assess the relationship between premorbid profile using NEO-PI 3 inventory and cognitive and behavioral/psychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvFTD), phenocopy frontotemporal dementia (phFTD), frontal variant of Alzheimer disease, bipolar disorder characterized with frontal damages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Behavioral variant of frontotemporal disorder (bvFTD) | – | Other: Submission of the NEO-PI-3 questionnaire, Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)A group of participants who fulfill Rascovsky criteria (2011) for behavioural variant Frontotemporal Dementia |
| Phenocopy frontotemporal dementia (phFTD) | – | Other: Submission of the NEO-PI-3 questionnaire, Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)A group of participants who fulfill who fulfill Rascovsky criteria (2011) for possible behavioural variant Frontotemporal Dementia and have no imaging abnormalities. |
| Frontal variant of Alzheimer disease | – | Other: Submission of the NEO-PI-3 questionnaire, Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)A group of participants who fulfill Ossenkopele criteria (2022) |
| Bipolar disorder | – | Other: Submission of the NEO-PI-3 questionnaire, Other: Submission of the Interpersonal Reactivity Index questionnaire (IRI)A group of participants who fulfill CIM 10 criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted among eligible patients with bvFTD, fvAD, phFTD, followed to Memory Resource and Research Centre at Nantes university Hospital CMRR or referred to the department for a neuropsychological assessment (bipolar disorder). It will prospectively enroll 120 participants.
Key inclusion criteria (4 listed)
- Patients with behavioral variant of frontotemporal disorder (bvFTD) according to Rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phFTD) who fulfill criteria for possible bvFTD and have no imaging abnormalities or patients with frontal variant of Alzheimer disease according to Ossenkopele criteria (2022), or patient with bipolar disorder according to CIM 10 criteria
- Score for Mini-mental state examination ≥ 18
- Patient with caregiver who has who has known him/her in the 10 years preceding the disease onset.
- Patient and caregiver consents (no opposition)
Key exclusion criteria (2 listed)
- Patient with no caregiver
- Pregnant or breast feeding women
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 |
|---|---|---|
| Submission of the NEO-PI-3 questionnaireThe questionnaire contains 240 statements. For each statement, the patient chooses the answer that best corresponds to their choice (FD: strongly disagree - D: disagree - N: neutral - A: agree - FA: strongly agree). | Other | Behavioral variant of frontotemporal disorder (bvFTD), Bipolar disorder, Frontal variant of Alzheimer disease, Phenocopy frontotemporal dementia (phFTD) |
| Submission of the Interpersonal Reactivity Index questionnaire (IRI)The test assesses two cognitive and two affective components of empathy that influence each other and affect attitudes and behaviors toward others. | Other | Behavioral variant of frontotemporal disorder (bvFTD), Bipolar disorder, Frontal variant of Alzheimer disease, Phenocopy frontotemporal dementia (phFTD) |
Primary outcome
Premorbid personality traits
Time frame: Baseline
Premorbid personality traits will be assessed by the NEO- NEO Personality Inventory-3 (NEO-PI-3). The NEO PI-3 measures the five major domains of personality: Neuroticism, Extraversion, Openness to experience, Conscientiousness and Agreeableness. Each domain is defined by 6 facets. NEOPI-3 includes 240 items and responses are made on a 5-point Likert -type scale ranging from strongly Disagree to strongly agree. The NEOPI 3 will be completed by a caregiver who has known the patient in the 10 years preceding the disease onset.
1 secondary outcome
Interpersonal Reactivity Index (IRI)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Behavioral Variant of Frontotemporal Disorder (bvFTD)
Recruiting
A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach
Bipolar Disorder, Frontotemporal Dementia, Behavioral Variant
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.
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 Behavioral Variant of Frontotemporal Disorder (bvFTD) and Phenocopy Frontotemporal Dementia (phFTD), 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire BOUTOLEAU-BRETONNIERE, PH (33 2 40 16 54 22, claire.boutoleaubretonniere@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premorbid personality traits (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 29 Jun 2026.