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New study probes brain inflammation to unlock dementia mysteries

NCT ID NCT06870838

Knowledge-focused Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This observational study looks at how brain inflammation contributes to frontotemporal lobar degeneration (FTLD), a group of disorders that cause dementia. Researchers will use advanced brain scans, blood tests, and spinal fluid analysis in 110 participants to find biomarkers that could help distinguish between different types of FTLD and track disease progression. The study does not test any treatment, but aims to improve understanding and future diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand and diagnose different types of frontotemporal dementia earlier.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve symptoms, and results may take years to influence patient care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

behavioral variant of frontotemporal dementia Corticobasal Degeneration corticobasal syndrome frontotemporal dementia Frontotemporal Lobar Degeneration Nerve Degeneration Neuroinflammatory Diseases primary progressive aphasia progressive non-fluent aphasia progressive supranuclear palsy semantic dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Behavioral variant frontotemporal dementia (BVFTD) Corticobasal syndrome (CBS) Frontotemporal lobar degeneration (FTLD) Primary progressive aphasia(PPA) Progressive supranuclear palsy (PSP)

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, 3015GE, Netherlands

  • Leiden University Medical Center

    Leiden, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.