Frontotemporal Lobar DegenerationPredict-PGRNNCT04014673
Natural History Characterization in Symptomatic and Asymptomatic Progranuline Gene Mutation Carriers
A study testing Behavioral : Characterization in people with Frontotemporal Lobar Degeneration, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The purpose of this study is to investigate whether cognitive deficits, structural and functional changes can be detected before symptom onset in presymptomatic progranuline mutation carriers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Lobar Degeneration
- What is being tested?
- Behavioral : Characterization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jan 2010to 6 Oct 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Signed informed consent for genetic and clinical study
- To be carrier of a PGRN mutation - Diagnosis criteria of FTD
- To be affiliated to the social security scheme
- Age ≥ 18
- To be first degree relative of a person carrying a PGRN mutation or first degree relative of FTD deceased patient whose PGRN mutation as been identified in the family
- Signed informed consent for genetic and clinical study
- To be affiliated to the social security scheme
Who cannot join
- Presence of one exclusion criteria from Diagnosis criteria of FTD. - Participation to another therapeutic trial. - Contra-indication to perform a brain MRI and/or PET-FDG
- Inability to lie one hour without moving
- Breastfeeding and pregnant women
- Presence of another intercurrent neurological pathology (vascular cerebral accident, tumor, etc.....)
- Presence of neurological or neurodegenerative disease
- Clinical proven signs of FTD, language disorder, praxis disorder, mnemic, of parkinson's syndrome or amyotrophic lateral sclerosis
Show all 10Show fewer
- Contra-indication to perform a brain MRI and/or PET-FDG
- Inability to lie one hour without moving
- Breastfeeding and pregnant women
- Severe vascular lesion , tumor or infectious brain imaging if an MRI was done previously
Trial locations and contacts
2 sites in 1 country.
France2 sites
Groupe Hospitalier Pitié-Salpêtrière - Charles Foix
Paris, 75013
Pitié Salpetriere Hospital
Paris, 75013
About this study
The purpose of this study is to investigate whether cognitive deficits, structural and functional changes can be detected before symptom onset in presymptomatic progranuline mutation carriers. The main objectives of the project are to identify novel cognitive, brain imaging markers and peripheral biomarkers for early diagnosis of FTLD, and to follow disease progression.
Read the detailed description
The project focuses on the progranulin (PGRN) gene mutation, one of the most frequent genetic forms of frontotemporal dementias (FTD, or frontotemporal lobar degeneration, FTLD). FTD is the second commonest cause of degenerative dementia in presenium after Alzheimer's disease. Behavioral and cognitive impairments progressively lead to dementia. Two major pathological subtypes are now defined in FTD, FTD-TDP and FTD-TAU.
FTD is difficult to detect at an early stage, and no clinical, biological or imaging features can predict the underlying pathology in living patients. Therapeutic perspectives have emerged against tau aggregation, PGRN deficit and C9orf72 expansion. Presymptomatic carriers of genetic FTD would benefit, before onset of symptoms, from these therapeutics that would delay or prevent the disease. At this step, it becomes crucial to develop markers to know how many years before symptoms, the pathological process begins, to treat the patients at the earliest stage of the disease. Markers are also needed to predict the pathology (FTD-TDP/FTD-tau) in patients that will be eligible for trials targeting specific pathological lesion. The main objectives of the project are to identify novel cognitive, brain imaging markers and peripheral biomarkers for early diagnosis of FTLD, and to follow disease progression. Ninety participants including 8 patients and 82 'at-risk' individuals will be recruited and evaluated by clinical partners of the project (Paris, Lille, Rouen, Toulouse, Saint-Etienne, Marseille, Nantes). 'At-risk individuals' are the first- degree relatives of PGRN patients, who have a high a risk (50%) to carry the mutation.
Brain structural changes will be evaluated by voxel-based morphometry (SPM12 software) to assess global brain atrophy in one with the evaluation of atypical shape patterns such as cortical thickness (Freesurfer software) and the study of the cortical sulci (BrainVISA/Morphologist software).
Fluoro Deoxy DGlucose-Positron Emission Tomography (FDG-PET) will allow the identification of brain metabolic markers. Then voxel-based methods using Statistical Parametric Mapping software will be applied to compare different groups or analyze correlations between brain metabolism and cognitive deficits.
The identification of peripheral biomarkers of disease onset and disease progression will take advantage from RNA sequencing, in order to study gene expression and RNA splicing alterations in lymphocytes of patients and 'at risk individuals'.
- Conditions
- Frontotemporal Lobar Degeneration
- Being tested
- Behavioral : Characterization
- Keywords
- Frontotemporal Dementia,, biomarkers,, brain Imaging PET
- Medical subject headings
- Frontotemporal Lobar Degeneration, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral : CharacterizationBehavioural
Behavioral scales and neuropsychological tests; MRI, SPECT/PET
| Study group | Role | What they receive |
|---|---|---|
| Patients with a PGRN gene mutation | Other | Symptomatic patients with a PGRN gene mutation Receives: Behavioral: Behavioral : Characterization |
| Presymptomatic individuals | Other | Asymptomatic 'At-risk' individuals with a PGRN gene mutation Receives: Behavioral: Behavioral : Characterization |
| healthy volunteers | Other | 'At-risk' individuals without a PGRN gene mutation Receives: Behavioral: Behavioral : Characterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change of Frontal Assessment Battery score (/18)
Executive functions changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Trail Making Test B-A time (seconds)
Cognitive flexibility changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Ekman's faces test score (/35)
Emotional assessment changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Faux-pas test score (/35)
Social cognition changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Digit span score
Short-term memory changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Free and Cued Selective Reminding test, total recall score (/48)
Long-term memory changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Boston Naming test score (/34)
Language changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Gestural Praxis battery score (/168)
Gestural praxis changes over time (rate of change in neuropsychological test)
Measured: at baseline 0 Months,at 42 Months, at 72 Months
Rate of change of Neuropsychiatric Inventory score (/144)
Behavioral changes over time (rate of change in neuropsychological questionnaire)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Rate of change of Apathy Evaluation Scale score (/42)
Apathy changes over time (rate of change in neuropsychological questionnaire)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Change in MRI morphological criteria (brain atrophy by voxel-based morphometry)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Change in cerebral metabolism by PET (metabolic markers by Fluoro-DeoxyDGlucose-Positron Emission Tomography (FDG-PET))
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Secondary outcomes (2)
Correlations between cognitive and behavioral scores, MRI morphological criteria, cerebral metabolism by FDG-PET and transcriptome analysis in presymptomatic subjects and in symptomatic patients at early disease stage
Voxel-based methods using Statistical Parametric Mapping software will be applied to compare different groups or analyze correlations between brain atrophy/metabolism and cognitive deficits.
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Differences in transcriptome analysis between symptomatic patients, asymptomatic carriers and controls.
Study gene expression and RNA splicing alterations in lymphocytes (RNA sequencing)
Measured: at baseline 0 Months,at 42 Months,at 72 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start19 Jan 2010
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frontotemporal Lobar DegenerationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LE BER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014673
- Sponsor's protocol ID
- P071229
- Acronym
- Predict-PGRN
- Status last verified
- Dec 2024
- First submitted
- 15 Apr 2019
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caroppo P, Habert MO, Durrleman S, Funkiewiez A, Perlbarg V, Hahn V, Bertin H, Gaubert M, Routier A, Hannequin D, Deramecourt V, Pasquier F, Rivaud-Pechoux S, Vercelletto M, Edouart G, Valabregue R, Lejeune P, Didic M, Corvol JC, Benali H, Lehericy S, Dubois B, Colliot O, Brice A, Le Ber I; Predict-PGRN study group. Lateral Temporal Lobe: An Early Imaging Marker of the Presymptomatic GRN Disease? J Alzheimers Dis. 2015;47(3):751-9. doi: 10.3233/JAD-150270.
PubMed 26401709Saracino D, Sellami L, Boniface H, Houot M, Pelegrini-Issac M, Funkiewiez A, Rinaldi D, Locatelli M, Azuar C, Causse-Lemercier V, Jaillard A, Pasquier F, Chastan M, Wallon D, Hitzel A, Pariente J, Pallardy A, Boutoleau-Bretonniere C, Guedj E, Didic M, Migliaccio R, Kas A, Habert MO, Le Ber I; Predict-PGRN. Brain Metabolic Profile in Presymptomatic GRN Carriers Throughout a 5-Year Follow-up. Neurology. 2023 Jan 24;100(4):e396-e407. doi: 10.1212/WNL.0000000000201439. Epub 2022 Oct 18.
PubMed 36257714Saracino D, Dorgham K, Camuzat A, Rinaldi D, Rametti-Lacroux A, Houot M, Clot F, Martin-Hardy P, Jornea L, Azuar C, Migliaccio R, Pasquier F, Couratier P, Auriacombe S, Sauvee M, Boutoleau-Bretonniere C, Pariente J, Didic M, Hannequin D, Wallon D; French Research Network on FTD/FTD-ALS; PREV-DEMALS and Predict-PGRN study groups; Colliot O, Dubois B, Brice A, Levy R, Forlani S, Le Ber I. Plasma NfL levels and longitudinal change rates in C9orf72 and GRN-associated diseases: from tailored references to clinical applications. J Neurol Neurosurg Psychiatry. 2021 Dec;92(12):1278-1288. doi: 10.1136/jnnp-2021-326914. Epub 2021 Aug 4.
PubMed 34349004
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Characterization in Symptomatic and Asymptomatic Progranuline Gene Mutation Carriers
- ClinicalTrials.gov ID
- NCT04014673
- Acronym / sponsor ID
- Predict-PGRN / P071229
- Conditions
- Frontotemporal Lobar Degeneration
- Keywords
- Frontotemporal Dementia,, biomarkers,, brain Imaging PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jan 2010 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 10 Jul 2019 (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.
The purpose of this study is to investigate whether cognitive deficits, structural and functional changes can be detected before symptom onset in presymptomatic progranuline mutation carriers. The main objectives of the project are to identify novel cognitive, brain imaging markers and peripheral biomarkers for early diagnosis of FTLD, and to follow disease progression.
Detailed description
The project focuses on the progranulin (PGRN) gene mutation, one of the most frequent genetic forms of frontotemporal dementias (FTD, or frontotemporal lobar degeneration, FTLD). FTD is the second commonest cause of degenerative dementia in presenium after Alzheimer's disease. Behavioral and cognitive impairments progressively lead to dementia. Two major pathological subtypes are now defined in FTD, FTD-TDP and FTD-TAU.
FTD is difficult to detect at an early stage, and no clinical, biological or imaging features can predict the underlying pathology in living patients. Therapeutic perspectives have emerged against tau aggregation, PGRN deficit and C9orf72 expansion. Presymptomatic carriers of genetic FTD would benefit, before onset of symptoms, from these therapeutics that would delay or prevent the disease. At this step, it becomes crucial to develop markers to know how many years before symptoms, the pathological process begins, to treat the patients at the earliest stage of the disease. Markers are also needed to predict the pathology (FTD-TDP/FTD-tau) in patients that will be eligible for trials targeting specific pathological lesion. The main objectives of the project are to identify novel cognitive, brain imaging markers and peripheral biomarkers for early diagnosis of FTLD, and to follow disease progression. Ninety participants including 8 patients and 82 'at-risk' individuals will be recruited and evaluated by clinical partners of the project (Paris, Lille, Rouen, Toulouse, Saint-Etienne, Marseille, Nantes). 'At-risk individuals' are the first- degree relatives of PGRN patients, who have a high a risk (50%) to carry the mutation.
Brain structural changes will be evaluated by voxel-based morphometry (SPM12 software) to assess global brain atrophy in one with the evaluation of atypical shape patterns such as cortical thickness (Freesurfer software) and the study of the cortical sulci (BrainVISA/Morphologist software).
Fluoro Deoxy DGlucose-Positron Emission Tomography (FDG-PET) will allow the identification of brain metabolic markers. Then voxel-based methods using Statistical Parametric Mapping software will be applied to compare different groups or analyze correlations between brain metabolism and cognitive deficits.
The identification of peripheral biomarkers of disease onset and disease progression will take advantage from RNA sequencing, in order to study gene expression and RNA splicing alterations in lymphocytes of patients and 'at risk individuals'.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with a PGRN gene mutation | Other | Behavioral: Behavioral : CharacterizationSymptomatic patients with a PGRN gene mutation |
| Presymptomatic individuals | Other | Behavioral: Behavioral : CharacterizationAsymptomatic 'At-risk' individuals with a PGRN gene mutation |
| healthy volunteers | Other | Behavioral: Behavioral : Characterization'At-risk' individuals without a PGRN gene mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18
- Signed informed consent for genetic and clinical study
- To be carrier of a PGRN mutation - Diagnosis criteria of FTD
- To be affiliated to the social security scheme
- Age ≥ 18
Key exclusion criteria (10 listed)
- Presence of one exclusion criteria from Diagnosis criteria of FTD. - Participation to another therapeutic trial. - Contra-indication to perform a brain MRI and/or PET-FDG
- Inability to lie one hour without moving
- Breastfeeding and pregnant women
- Presence of another intercurrent neurological pathology (vascular cerebral accident, tumor, etc.....)
- Presence of neurological or neurodegenerative disease
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 |
|---|---|---|
| Behavioral : CharacterizationBehavioral scales and neuropsychological tests; MRI, SPECT/PET | Behavioural | Patients with a PGRN gene mutation, Presymptomatic individuals, healthy volunteers |
Primary outcome
Rate of change of Frontal Assessment Battery score (/18)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Executive functions changes over time (rate of change in neuropsychological test)
Rate of change of Trail Making Test B-A time (seconds)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Cognitive flexibility changes over time (rate of change in neuropsychological test)
Rate of change of Ekman's faces test score (/35)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Emotional assessment changes over time (rate of change in neuropsychological test)
Rate of change of Faux-pas test score (/35)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Social cognition changes over time (rate of change in neuropsychological test)
Rate of change of Digit span score
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Short-term memory changes over time (rate of change in neuropsychological test)
Rate of change of Free and Cued Selective Reminding test, total recall score (/48)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Long-term memory changes over time (rate of change in neuropsychological test)
Rate of change of Boston Naming test score (/34)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Language changes over time (rate of change in neuropsychological test)
Rate of change of Gestural Praxis battery score (/168)
Time frame: at baseline 0 Months,at 42 Months, at 72 Months
Gestural praxis changes over time (rate of change in neuropsychological test)
Rate of change of Neuropsychiatric Inventory score (/144)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Behavioral changes over time (rate of change in neuropsychological questionnaire)
Rate of change of Apathy Evaluation Scale score (/42)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Apathy changes over time (rate of change in neuropsychological questionnaire)
Change in MRI morphological criteria (brain atrophy by voxel-based morphometry)
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Change in cerebral metabolism by PET (metabolic markers by Fluoro-DeoxyDGlucose-Positron Emission Tomography (FDG-PET))
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
2 secondary outcomes
Correlations between cognitive and behavioral scores, MRI morphological criteria, cerebral metabolism by FDG-PET and transcriptome analysis in presymptomatic subjects and in symptomatic patients at early disease stage
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
Differences in transcriptome analysis between symptomatic patients, asymptomatic carriers and controls.
Time frame: at baseline 0 Months,at 42 Months,at 72 Months
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 24 Dec 2024.
- Background: PubMed 26401709Caroppo P, Habert MO, Durrleman S, Funkiewiez A, Perlbarg V, Hahn V, Bertin H, Gaubert M, Routier A, Hannequin D, Deramecourt V, Pasquier F, Rivaud-Pechoux S, Vercelletto M, Edouart G, Valabregue R, Lejeune P, Didic M, Corvol JC, Benali H, Lehericy S, Dubois B, Colliot O, Brice A, Le Ber I; Predict-PGRN study group. Lateral Temporal Lobe: An Early Imaging Marker of the Presymptomatic GRN Disease? J Alzheimers Dis. 2015;47(3):751-9. doi: 10.3233/JAD-150270.
- Results publication: PubMed 36257714Saracino D, Sellami L, Boniface H, Houot M, Pelegrini-Issac M, Funkiewiez A, Rinaldi D, Locatelli M, Azuar C, Causse-Lemercier V, Jaillard A, Pasquier F, Chastan M, Wallon D, Hitzel A, Pariente J, Pallardy A, Boutoleau-Bretonniere C, Guedj E, Didic M, Migliaccio R, Kas A, Habert MO, Le Ber I; Predict-PGRN. Brain Metabolic Profile in Presymptomatic GRN Carriers Throughout a 5-Year Follow-up. Neurology. 2023 Jan 24;100(4):e396-e407. doi: 10.1212/WNL.0000000000201439. Epub 2022 Oct 18.
- Derived from this study: PubMed 34349004Saracino D, Dorgham K, Camuzat A, Rinaldi D, Rametti-Lacroux A, Houot M, Clot F, Martin-Hardy P, Jornea L, Azuar C, Migliaccio R, Pasquier F, Couratier P, Auriacombe S, Sauvee M, Boutoleau-Bretonniere C, Pariente J, Didic M, Hannequin D, Wallon D; French Research Network on FTD/FTD-ALS; PREV-DEMALS and Predict-PGRN study groups; Colliot O, Dubois B, Brice A, Levy R, Forlani S, Le Ber I. Plasma NfL levels and longitudinal change rates in C9orf72 and GRN-associated diseases: from tailored references to clinical applications. J Neurol Neurosurg Psychiatry. 2021 Dec;92(12):1278-1288. doi: 10.1136/jnnp-2021-326914. Epub 2021 Aug 4.
- Individual participant dataSharing planned: No
Related trials for Frontotemporal Lobar Degeneration
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
PSP - Progressive Supranuclear Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
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.
Isabelle LE BER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral : Characterization in people with Frontotemporal Lobar Degeneration, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 8 inclusion and 10 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 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Rate of change of Frontal Assessment Battery score (/18) (time frame: at baseline 0 Months,at 42 Months,at 72 Months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014673, which also lists 3 linked publications.
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 24 Dec 2024.