Corticobasal Syndrome(CBS)NCT06870838
Neuroinflammation in FTLD
An observational study of Corticobasal Syndrome(CBS) and Primary Progressive Aphasia(PPA), run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
The goal of this observational study is to investigate the role of neuroinflammation in frontotemporal lobar degeneration (FTLD). The main aims of this study are: 1. To elucidate the role and timing of neuroinflammation in FTLD by using a combination of clinical measures, 7T MRI, and CSF biomarkers; 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corticobasal Syndrome(CBS), Primary Progressive Aphasia(PPA), Progressive Supranuclear Palsy(PSP)
- What is being tested?
- 7T MRI scan, CSF and Blood withdrawal
- How many people
- 110 participants
- Where
- 2 sitesNetherlands
- Study dates
- 25 Jul 2023to Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with probable FTLD-tau (n =25) are defined as a clinical diagnosis of PSP, CBS, or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation. In patients with CBS or nfvPPA, CSF analyses and genetic screening will be used to rule out underlying AD pathology or having a pathogenetic variant causing FTLD-TDP pathology. Patients with probable FTLD-TDP (n=25) are indicated by either a clinical diagnosis of svPPA, FTLD-ALS or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 HRE. At-risk individuals (n=50) will be recruited through our ongoing FTD-RisC project. These individuals have no clinical signs of an FTLD phenotype, but have a first degree relative with genetic FTLD. These subjects have 50% risk to carry one of the genetic variants. Through anonymous genetic screening, this group will be divided into presymptomatic mutation carriers and healthy individuals. If necessary for age-matching, 10 healthy controls will be included.
Who may be able to join
- Ability to undergo MRI scanning
- For probable FTLD-tau: a clinical diagnosis of PSP, CBS or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation
- For probable FTLD-TDP: a clinical diagnosis of svPPA or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 repeat expansion
- For presymptomatic mutation carriers: a MAPT mutation, GRN mutation or a C9orf72 mutation without clinical sign of a FTLD spectrum phenotype (CDR 0) For control subjects: no known neurological or psychiatric disorder
- For controls: no known neurological or psychiatric disorder
Who cannot join
- Other neurological or psychiatric disorder that may affect cognitive functions, such as a brain tumour, multiple sclerosis or drug or alcohol abuse or use of psycho-active medications
- CSF profile (β-amyloid, p-tau, t-tau) suggestive of AD pathology
- Clinical dementia Rating Scale (CDR) score >1
- Contra-indication to undergo MRI
- Contra-indication to undergo lumbar puncture
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden
Erasmus MC
Rotterdam, 3015GE
About this study
Official title: Neuroinflammation in Frontotemporal Lobar Degeneration - a Multimodal Biomarker Study
The goal of this observational study is to investigate the role of neuroinflammation in frontotemporal lobar degeneration (FTLD). The main aims of this study are:
- To elucidate the role and timing of neuroinflammation in FTLD by using a combination of clinical measures, 7T MRI, and CSF biomarkers;
- To differentiate FTLD-TDP and FTLD-tau during life using biomarkers for neuroinflammation;
- To identify biomarkers to predict and monitor disease progression in FTLD;
Secondary aim:
- To explore the role of brain clearance in the disease process of FTLD.
Participants will undergo 7T MRI scans, blood and CSF collection, clinical, neurological, and neuropsychological evaluation.
Read the detailed description
At baseline, the study will involve the following procedures: clinical assessment including neurological and neuropsychological investigation, blood sampling, and a voluntarily lumbar puncture on the first day at the Erasmus MC University Medical Center, (EMC) and two sessions of 7T MRI scanning on the second day at the Leiden University Medical Center (LUMC). After one year, clinical assessment and blood analyses will be repeated in the EMC to assess disease progression. The aim is to include 25 patients with probable or definite FTLD-tau, 25 patients with probable or definite FTLD-TDP, 50 healthy individuals with 50% risk to carry a mutation in MAPT or GRN, or the C9orf72 HRE. If necessary for age matching, 10 additional healthy subjects without increased risk of FTLD will be included.
- Conditions
- Corticobasal Syndrome(CBS), Primary Progressive Aphasia(PPA), Progressive Supranuclear Palsy(PSP), Behavioral Variant Frontotemporal Dementia (bvFTD), Frontotemporal Lobar Degeneration (FTLD)
- Being tested
- 7T MRI scan, CSF, Blood withdrawal, Neuropsychological assessment, Clinical measures
- Keywords
- Frontotemporal lobar degeneration, Iron accumulation, 7T-MRI, Neurodegeneration, Neuroinflammation, QSM, CSF, Blood, MRS, dMRS
- Medical subject headings
- Corticobasal Degeneration, Aphasia, Primary Progressive, Supranuclear Palsy, Progressive, Frontotemporal Lobar Degeneration, Nerve Degeneration, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRI scanDiagnostic test
MRI-scanning of the brain using a 7T MRI scanner
CSFDiagnostic test
CSF collection via lumbar puncture
Blood withdrawalDiagnostic test
Blood is collected by doing a blood withdrawal
Neuropsychological assessmentDiagnostic test
Tests for memory, language, attention, executive functions, praxis, social cognition, visuoconstructive skills
Clinical measuresDiagnostic test
Medical history, neurological assessment, neuropsychiatric inventory
| Study group | Role | What they receive |
|---|---|---|
| Patients with probable FTLD-tau | clinical diagnosis of PSP, CBS, or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation Receives: Diagnostic Test: 7T MRI scan; Diagnostic Test: CSF; Diagnostic Test: Blood withdrawal; Diagnostic Test: Neuropsychological assessment; Diagnostic Test: Clinical measures | |
| Patients with probable FTLD-TDP | a clinical diagnosis of svPPA, FTLD-ALS or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 HRE Receives: Diagnostic Test: 7T MRI scan; Diagnostic Test: CSF; Diagnostic Test: Blood withdrawal; Diagnostic Test: Neuropsychological assessment; Diagnostic Test: Clinical measures | |
| At-risk individuals | Healthy individuals with a first degree relative with a MAPT or GRN mutation or C9orf72 HRE. These subjects therefore all have a 50% risk to carry one of these genetic variants and develop FTLD later in life. Receives: Diagnostic Test: 7T MRI scan; Diagnostic Test: CSF; Diagnostic Test: Blood withdrawal; Diagnostic Test: Neuropsychological assessment; Diagnostic Test: Clinical measures | |
| Healthy controls | Healthy individuals without increased risk to develop FTLD Receives: Diagnostic Test: 7T MRI scan; Diagnostic Test: CSF; Diagnostic Test: Blood withdrawal; Diagnostic Test: Neuropsychological assessment; Diagnostic Test: Clinical measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR Spectroscopy in the lateral anterior cingulate cortex
MR Spectroscopy data analysis in a single volume of interest in the lateral anterior cingulate cortex to assess changes in metabolites related to neurodegeneration and neuroinflammation. The analysis in LCModel will give us metabolite concentrations for total N-acetyl-aspertate (tNAA), glutamate (Glu), myo-inositol (mI), and total choline compound (tCho).
Measured: At baseline
Diffusion weighted MR spectroscopy in the lateral anterior cingulate cortex
Diffusion weighted MR Spectroscopy data analysis in a single volume of interest in the lateral anterior cingulate cortex to assess changes in the apparent diffusion coefficients of specific metabolites related to neurodegeneration and neuroinflammation. The analysis done in LCModel will give us metabolite apparent diffusion coefficients for total N-acetyl-aspertate (tNAA), glutamate (Glu), myo-inositol (mI), and total choline compound (tCho).
Measured: At baseline
Quantitative susceptibility mapping for iron localization and quantification
Cross-sectional MR analysis to determine iron accumulation in the brain. The analysis will be performed with the SEPIA toolbox to obtain quantitative susceptibility values in various brain regions.
Measured: At baseline
Neurodegeneration biomarkers in blood
Biomarkers for neurodegeneration (neurofilament light chain (NFL), total tau) in blood.
Measured: At baseline
Neurodegeneration biomarkers in CSF
Biomarkers for neurodegeneration (neurofilament light chain (NFL), total tau) in CSF.
Measured: At baseline
Neuroinflammation biomarkers in CSF
Biomarkers for neuroinflammation (YKL-40, TREM-1, TREM-2, IL-1, IL-6, TNF-α, GFAP, CHIT1) in CSF.
Measured: At baseline
Iron accumulation biomarkers in blood
Biomarkers for iron accumulation ( ferritin, and iron) in blood.
Measured: At baseline
Iron acccumulation biomarkers in CSF
Biomarkers for iron accumulation (transferritin, ferritin, and iron) in CSF.
Measured: At baseline
Secondary outcomes (4)
Clinical and neuropsycological evaluation: Clinical dementia rating scale
Cognitive and neuropsychological assessments for clinical dementia rating scale (CDR) to assess the cognitive functioning of the participant. The CDR is a combination score including multiple neuropsychological functioning on multiple domains (memory, language, attention, executive function, praxis, social cognition, and visuoconstructive skills) and clinical evaluation. A score of 0 means not impaired or no symptoms, a score of 0.5 means prodromal, and a score of 1 and higher (up to 3) reflects a symptomatic individual.
Measured: At baseline and 1 year follow-up
Clinical and neuropsycological evaluation: Montreal Cognitive Assessment
Cognitive and neuropsychological assessments for Montreal Cognitive Assessment (MoCA) to assess the cognitive functioning of the participant. A total score of 30 can be obtained. A higher score reflects a better performance. The cut-off point for a normal score is 26. A score lower than 26 reflects impairments or one or more cognitive domains.
Measured: At baseline and 1 year follow-up
Clinical evaluation: Parkinson's Disease Rating Score
Neurological examination for Unified Parkinson's Disease rating score (UPDRS). The score will be between 0 and 260, with a lower score indicating no symptoms and a total score of 260 indicating all symptoms.
Measured: At baseline and 1 year follow-up
Clinical evaluation: Neuropsychiatric assessment
Neuropsychiatric examination with the neuropsychiatric inventory (NPI) to assess psychiatric symptoms. The NPI has a total score range of [0, 144], with a higher score indicating more neuropsychiatric symptoms. A NPI score higher than 0 indicates the presence of one or more symptoms, a score of 4 or higher indicates moderate symptoms.
Measured: At baseline and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start25 Jul 2023
- Primary completion1 Aug 2025
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corticobasal Syndrome(CBS)Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, Matthias van Osch, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870838
- Sponsor's protocol ID
- P21.090
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prinse FAM, van der Weerd L, van Swieten JC, Ronen I, Seelaar H, Hirschler L, Najac C, Dopper EGP. Investigating the role of neuroinflammation and brain clearance in frontotemporal lobar degeneration using 7T MRI and fluid biomarkers: protocol for a cross-sectional study in a tertiary care setting. BMJ Open. 2025 Aug 3;15(8):e102668. doi: 10.1136/bmjopen-2025-102668.
PubMed 40754329
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation in Frontotemporal Lobar Degeneration - a Multimodal Biomarker Study
- ClinicalTrials.gov ID
- NCT06870838
- Acronym / sponsor ID
- P21.090
- Conditions
- Corticobasal Syndrome(CBS), Primary Progressive Aphasia(PPA), Progressive Supranuclear Palsy(PSP), Behavioral Variant Frontotemporal Dementia (bvFTD), Frontotemporal Lobar Degeneration (FTLD)
- Keywords
- Frontotemporal lobar degeneration, Iron accumulation, 7T-MRI, Neurodegeneration, Neuroinflammation, QSM, CSF, Blood
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Mar 2025 (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 goal of this observational study is to investigate the role of neuroinflammation in frontotemporal lobar degeneration (FTLD). The main aims of this study are:
- To elucidate the role and timing of neuroinflammation in FTLD by using a combination of clinical measures, 7T MRI, and CSF biomarkers;
- To differentiate FTLD-TDP and FTLD-tau during life using biomarkers for neuroinflammation;
- To identify biomarkers to predict and monitor disease progression in FTLD;
Secondary aim:
- To explore the role of brain clearance in the disease process of FTLD.
Participants will undergo 7T MRI scans, blood and CSF collection, clinical, neurological, and neuropsychological evaluation.
Detailed description
At baseline, the study will involve the following procedures: clinical assessment including neurological and neuropsychological investigation, blood sampling, and a voluntarily lumbar puncture on the first day at the Erasmus MC University Medical Center, (EMC) and two sessions of 7T MRI scanning on the second day at the Leiden University Medical Center (LUMC). After one year, clinical assessment and blood analyses will be repeated in the EMC to assess disease progression. The aim is to include 25 patients with probable or definite FTLD-tau, 25 patients with probable or definite FTLD-TDP, 50 healthy individuals with 50% risk to carry a mutation in MAPT or GRN, or the C9orf72 HRE. If necessary for age matching, 10 additional healthy subjects without increased risk of FTLD will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with probable FTLD-tau | – | Diagnostic Test: 7T MRI scan, Diagnostic Test: CSF, Diagnostic Test: Blood withdrawal, Diagnostic Test: Neuropsychological assessment, Diagnostic Test: Clinical measuresclinical diagnosis of PSP, CBS, or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation |
| Patients with probable FTLD-TDP | – | Diagnostic Test: 7T MRI scan, Diagnostic Test: CSF, Diagnostic Test: Blood withdrawal, Diagnostic Test: Neuropsychological assessment, Diagnostic Test: Clinical measuresa clinical diagnosis of svPPA, FTLD-ALS or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 HRE |
| At-risk individuals | – | Diagnostic Test: 7T MRI scan, Diagnostic Test: CSF, Diagnostic Test: Blood withdrawal, Diagnostic Test: Neuropsychological assessment, Diagnostic Test: Clinical measuresHealthy individuals with a first degree relative with a MAPT or GRN mutation or C9orf72 HRE. These subjects therefore all have a 50% risk to carry one of these genetic variants and develop FTLD later in life. |
| Healthy controls | – | Diagnostic Test: 7T MRI scan, Diagnostic Test: CSF, Diagnostic Test: Blood withdrawal, Diagnostic Test: Neuropsychological assessment, Diagnostic Test: Clinical measuresHealthy individuals without increased risk to develop FTLD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with probable FTLD-tau (n =25) are defined as a clinical diagnosis of PSP, CBS, or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation. In patients with CBS or nfvPPA, CSF analyses and genetic screening will be used to rule out underlying AD pathology or having a pathogenetic variant causing FTLD-TDP pathology. Patients with probable FTLD-TDP (n=25) are indicated by either a clinical diagnosis of svPPA, FTLD-ALS or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 HRE. At-risk individuals (n=50) will be recruited through our ongoing FTD-RisC project. These individuals have no clinical signs of an FTLD phenotype, but have a first degree relative with genetic FTLD. These subjects have 50% risk to carry one of the genetic variants. Through anonymous genetic screening, this group will be divided into presymptomatic mutation carriers and healthy individuals. If necessary for age-matching, 10 healthy controls will be included.
Key inclusion criteria (5 listed)
- Ability to undergo MRI scanning
- For probable FTLD-tau: a clinical diagnosis of PSP, CBS or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation
- For probable FTLD-TDP: a clinical diagnosis of svPPA or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 repeat expansion
- For presymptomatic mutation carriers: a MAPT mutation, GRN mutation or a C9orf72 mutation without clinical sign of a FTLD spectrum phenotype (CDR 0) For control subjects: no known neurological or psychiatric disorder
- For controls: no known neurological or psychiatric disorder
Key exclusion criteria (5 listed)
- Other neurological or psychiatric disorder that may affect cognitive functions, such as a brain tumour, multiple sclerosis or drug or alcohol abuse or use of psycho-active medications
- CSF profile (β-amyloid, p-tau, t-tau) suggestive of AD pathology
- Clinical dementia Rating Scale (CDR) score >1
- Contra-indication to undergo MRI
- Contra-indication to undergo lumbar puncture
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 |
|---|---|---|
| 7T MRI scanMRI-scanning of the brain using a 7T MRI scanner | Diagnostic test | At-risk individuals, Healthy controls, Patients with probable FTLD-TDP, Patients with probable FTLD-tau |
| CSFCSF collection via lumbar puncture | Diagnostic test | At-risk individuals, Healthy controls, Patients with probable FTLD-TDP, Patients with probable FTLD-tau |
| Blood withdrawalBlood is collected by doing a blood withdrawal | Diagnostic test | At-risk individuals, Healthy controls, Patients with probable FTLD-TDP, Patients with probable FTLD-tau |
| Neuropsychological assessmentTests for memory, language, attention, executive functions, praxis, social cognition, visuoconstructive skills | Diagnostic test | At-risk individuals, Healthy controls, Patients with probable FTLD-TDP, Patients with probable FTLD-tau |
| Clinical measuresMedical history, neurological assessment, neuropsychiatric inventory | Diagnostic test | At-risk individuals, Healthy controls, Patients with probable FTLD-TDP, Patients with probable FTLD-tau |
Primary outcome
MR Spectroscopy in the lateral anterior cingulate cortex
Time frame: At baseline
MR Spectroscopy data analysis in a single volume of interest in the lateral anterior cingulate cortex to assess changes in metabolites related to neurodegeneration and neuroinflammation. The analysis in LCModel will give us metabolite concentrations for total N-acetyl-aspertate (tNAA), glutamate (Glu), myo-inositol (mI), and total choline compound (tCho).
Diffusion weighted MR spectroscopy in the lateral anterior cingulate cortex
Time frame: At baseline
Diffusion weighted MR Spectroscopy data analysis in a single volume of interest in the lateral anterior cingulate cortex to assess changes in the apparent diffusion coefficients of specific metabolites related to neurodegeneration and neuroinflammation. The analysis done in LCModel will give us metabolite apparent diffusion coefficients for total N-acetyl-aspertate (tNAA), glutamate (Glu), myo-inositol (mI), and total choline compound (tCho).
Quantitative susceptibility mapping for iron localization and quantification
Time frame: At baseline
Cross-sectional MR analysis to determine iron accumulation in the brain. The analysis will be performed with the SEPIA toolbox to obtain quantitative susceptibility values in various brain regions.
Neurodegeneration biomarkers in blood
Time frame: At baseline
Biomarkers for neurodegeneration (neurofilament light chain (NFL), total tau) in blood.
Neurodegeneration biomarkers in CSF
Time frame: At baseline
Biomarkers for neurodegeneration (neurofilament light chain (NFL), total tau) in CSF.
Neuroinflammation biomarkers in CSF
Time frame: At baseline
Biomarkers for neuroinflammation (YKL-40, TREM-1, TREM-2, IL-1, IL-6, TNF-α, GFAP, CHIT1) in CSF.
Iron accumulation biomarkers in blood
Time frame: At baseline
Biomarkers for iron accumulation ( ferritin, and iron) in blood.
Iron acccumulation biomarkers in CSF
Time frame: At baseline
Biomarkers for iron accumulation (transferritin, ferritin, and iron) in CSF.
4 secondary outcomes
Clinical and neuropsycological evaluation: Clinical dementia rating scale
Time frame: At baseline and 1 year follow-up
Clinical and neuropsycological evaluation: Montreal Cognitive Assessment
Time frame: At baseline and 1 year follow-up
Clinical evaluation: Parkinson's Disease Rating Score
Time frame: At baseline and 1 year follow-up
Clinical evaluation: Neuropsychiatric assessment
Time frame: At baseline and 1 year follow-up
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 11 Sep 2025.
- Derived from this study: PubMed 40754329Prinse FAM, van der Weerd L, van Swieten JC, Ronen I, Seelaar H, Hirschler L, Najac C, Dopper EGP. Investigating the role of neuroinflammation and brain clearance in frontotemporal lobar degeneration using 7T MRI and fluid biomarkers: protocol for a cross-sectional study in a tertiary care setting. BMJ Open. 2025 Aug 3;15(8):e102668. doi: 10.1136/bmjopen-2025-102668.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corticobasal Syndrome(CBS) and Primary Progressive Aphasia(PPA), run by Leiden University Medical Center at 2 sites in Netherlands.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. 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 Netherlands. 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?
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?
MR Spectroscopy in the lateral anterior cingulate cortex (time frame: At baseline). The study lists 8 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 NCT06870838, which also lists 1 linked publication.
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 11 Sep 2025.