Frontotemporal Dementia (FTD)Early Phase 1NCT06891716
[18F]ACI-19626 PET in TDP-43 Proteinopathies
A Early Phase 1 study testing [18F]ACI-19626 in people with Frontotemporal Dementia (FTD) and Amyotrophic Lateral Sclerosis (ALS), run by AC Immune SA at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 [involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)] using a new positron emission tomography (PET) tracer called… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS), TDP-43 Proteinopathies
- What is being tested?
- [18F]ACI-19626
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jan 2025to Nov 2026
- Phase
- Early Phase 1
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is able to provide written informed consent (IC), which must be obtained before any assessment is performed.
- Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use reliable contraception method(s) and not donate eggs for 30 days after the PET scan. Subjects without documentation of non-childbearing potential will perform serum pregnancy testing at screening and urine pregnancy test before the PET scan. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the PI (e.g., Müllerian agenesis). Women of childbearing potential must commit to remain abstinent (refrain from heterosexual intercourse) or use a reliable form of birth control (e.g. a barrier, hormonal contraception method or intrauterine device), during the study and until 30 days after the last PET scan. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. Women of childbearing potential must commit to not donate ovum during the study and until 30 days after the last PET scan.
- Male subjects with their partners of childbearing potential must commit to the use of a barrier method of contraception during the study and until 90 days after the last PET scan.
- Male subjects must commit to not donate sperm during the study and until 90 days after the last PET scan.
- Willing and able to cooperate with study procedures.
- Ability to tolerate lying in the scanner for up to 90 minutes without excessive movements sufficient to cause significant motion artifact on the PET scans, or if necessary up to 120 minutes with a break.
Show all 20Show fewer
- For subjects receiving arterial cannulation, adequate circulation to the hand for safe placement of arterial line and coagulation (International Normalized Ratio [INR], Prothrombin Time [PT] and Partial Thromboplastin Time [PTT]).
- Additional Inclusion Criteria for Healthy Controls:
- Males and females aged 40-70 years.
- Healthy with no clinically relevant finding on physical and neurological examination at Screening and upon reporting to the clinic for the [18F]ACI-19626 Imaging Visit.
- No family history of TDP-43 proteinopathies, including FTD, ALS, or other early-onset neurological disease associated with dementia and/or movement disorders.
- No personal history of clinically significant neurological and/or psychiatric disorders.
- No evidence of neurodegeneration or other neurological pathology on magnetic resonance imaging (MRI) performed either as part of Screening or on previously acquired MRI scan (within 6 months prior to signing consent).
- Montreal Cognitive Assessment (MoCA) score ≥ 26.
- No cognitive or behavioural impairment as judged by the PI.
- Additional Inclusion Criteria for Participants with TDP-43 proteinopathies:
- Males and females aged ≥ 40 years.
- Subjects diagnosed with any of the following: Symptomatic GRN, C9Orf72 or other mutation carriers with FTD or FTD-MND and CDR® plus NACC FTLD-GS of ≥ 0.5, or asymptomatic GRN, C9Orf72 or other mutation carriers; sporadic probable behavioral FTD per International consensus criteria or primary progressive aphasia, with or without clinical or electrophysiological indications of MND; ALS meeting the El Escorial criteria of probable, possible or definite ALS; Other neurodegenerative diseases, e.g. AD or suspected LATE pathology
- Confirmed genetic status for the subjects with genetic FTD, FTD-MND or ALS (e.g. GRN, C9orf72 or other mutations)
- For sporadic FTD / FTD-MND subjects: brain MRI consistent with a diagnosis of FTD, with no evidence of focal disease to account for the subject's neurological, cognitive or behavioral symptoms.
Who cannot join
- Current or prior history of any alcohol or drug abuse in the past 2 years.
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical condition.
- Known history of hypersensitivity, including hypersensitivity to the active substances used for [18F]ACI-19626 or derivatives, or to any of the associated excipients.
- Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit (including the procedures in this clinical protocol).
- Pregnant or lactating.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
Show all 17Show fewer
- Unsuitable veins for repeated venipuncture.
- Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
- Treatment with any antihemostasis medication (e.g., warfarin, heparin, thrombin inhibitors, Factor Xa inhibitors, streptokinase, urokinase, tissue plasminogen activators) within 2 weeks of the planned arterial cannula placement (if performed) of either the baseline or retest imaging.
- Anaemia (for subjects undergoing arterial cannulation) considered clinically significant by the PI
- Coagulopathies
- Loss or donation of blood over 500 mL within four months prior to study visits for subjects undergoing arterial cannulation
- Subject has received an investigational drug within the last 30 days or 5 half-lives prior to the screening assessments, whichever is longer unless there is documented evidence that the subject was treated with placebo only.
- Additional Exclusion Criteria for Participants with TDP-43 proteinopathies:
- Prior participation in DMT clinical trials which could interfere with the TDP-43 protein itself or its metabolism, including but not limited to gene therapy, unless there is documented evidence that the subject was treated with placebo only.
- MRI scan showing structural evidence of alternative pathology not consistent with TDP-43 proteinopathies which could cause the subject's symptoms.
- Mutations with known absence of TDP-43 pathology, e.g. SOD1 or FUS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Elsmarieke van de Giessen, MD, +31(0)6 19282386, e.m.vandegiessen@amsterdamumc.nl
Elsmarieke van de Giessen, MD
About this study
Official title: Phase 1 Study to Evaluate [18F]ACI-19626 as a Potential PET Radioligand for Imaging TDP-43 Inclusions in the Brain of Patients With Suspected TDP-43 Proteinopathies Compared With Healthy Controls
The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 [involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)] using a new positron emission tomography (PET) tracer called [18F]ACI-19626. Both healthy people and people with (suspected) TDP-43 accumulation will participate to this trial.
The main questions it aims to answer are:
Read more
- whether [18F]ACI-19626 is safe and well tolerated when injected into participants
- whether [18F]ACI-19626 reliably detects abnormal TDP-43 in the brain using PET technique.
- whether there are differences in the amount of this protein between people with diseases related to TDP-43 accumulation in the brain and people without these diseases.
Participants will:
- Visit the clinic to consent to their participation and to ensure they are eligible (physical and neurological examinations, questionnaires, blood and urine tests, ECG and MRI in some cases).
- Visit the clinic to receive the tracer [18F]ACI-19626 intravenously and be scanned in a PET scanner, during which blood will be collected.
- Receive a phone call from the clinic 2 to 4 days after the PET scan to report any symptoms and side-effects that they may be having.
Some of the participants may be asked to come again to the clinic for a second PET scan, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.
Read the detailed description
This trial aims to evaluate the effects (i.e. safety and uptake) of a new radiotracer molecule. Study participants will take part in the study by attending two to three study visits over a period of up to 3 months (from the screening visit up to the last study visit).
The study consists of three parts in which a total of up to 45 participants may be included:
Part 1 may include in total up to 15 participants:
- up to 5 healthy controls (HCs)
- up to 5 symptomatic progranulin gene (GRN) and up to 5 symptomatic chromosome 9 open reading frame 72 (C9orf72) mutation carriers with FTD (including prodromal) either with or without motor neuron disease (MND) characteristics.
If the safety and dosimetry are satisfactory in the first subjects and sufficient data are obtained from this part, Part 2 may be initiated.
Part 2 may include in total up to 30 participants including:
- up to 25 patients with TDP-43 proteinopathies: up to 10 additional mutation carriers (including other mutations than GRN and C9orf72, and/or asymptomatic carriers) with FTD (including prodromal) either with or without MND characteristics; up to 10 sporadic or genetic (excluding mutations with known absence of TDP-43 pathology, e.g. Superoxide Dismutase 1 (SOD1) or fused in sarcoma protein gene (FUS)) ALS; up to 10 suspected TDP-43 related sporadic FTD or FTD-MND; up to 5 patients with other neurodegenerative diseases, e.g. AD or suspected Limbic-Predominant Age-related TDP-43 Encephalopathy (LATE) pathology
- up to 5 additional HVs may also be imaged, if necessary, to enable a better distinction of brain binding in this population compared to the population of subjects with TDP-43 proteinopathies
Part 3 aims to assess test-retest reliability. Up to 5 participants from Part 1 and/or Part 2 will have an additional scan within 1 month after their first scan to determine test-retest reliability.
- Conditions
- Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS), TDP-43 Proteinopathies, Suspected Limbic Predominant Age-related TDP-43 Encephalopathy (LATE), Alzheimer's Disease (AD)
- Being tested
- [18F]ACI-19626
- Medical subject headings
- Frontotemporal Dementia, Amyotrophic Lateral Sclerosis, TDP-43 Proteinopathies, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]ACI-19626Other
[18F]ACI-19626 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of TDP-43 deposits.
| Study group | Role | What they receive |
|---|---|---|
| Participants with suspected TDP-43 proteinopathies | Experimental | The study population will be composed of participants with suspected TDP-43 proteinopathies Receives: Other: [18F]ACI-19626 |
| Healthy controls | Active comparator | The study population will be composed of healthy controls. Receives: Other: [18F]ACI-19626 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs) assessed by severity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Measured: From Informed Consent Signature (screening) to safety phone call after PET scan (i.e. up to 3 months in total)
Number of participants with clinically significant changes in vital signs measurements
Vital signs measurements will be performed after the PET scan is completed and will be compared with measurements performed before the injection of [18F]ACI-19626.
Measured: During PET scan visit (i.e. at Day 0): before [18F]ACI-19626 injection and after the PET scan is completed
Brain uptake of the tracer [18F]ACI-19626
[18F]ACI-19626 brain uptake in relevant regions of interest of the brain will be measured with PET scan and the mean of each group (participants with TDP-proteinopathies and healthy controls) will be calculated.
Measured: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
Assessment of the optimal kinetic model quantification of [18F]ACI-19626 tracer uptake
The selection of the optimal kinetic model will be done based on the Akaike's information criterion
Measured: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
Radiation dosimetry after one [18F]ACI-19626 PET scan
The radiation dose absorbed by relevant vital organs and the total effective dose will be measured, and the mean of scanned participants will be calculated
Measured: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
Secondary outcomes (2)
Assessment of simplified methods to quantify brain uptake of the tracer [18F]ACI-19626
The validity of simplified reference tissue models will be assessed by determining correlation coefficients with corresponding outcome parameters from the optimal tracer full kinetic model
Measured: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
Variability of the tracer brain uptake between two [18F]ACI-19626 PET scans (test/retest)
The repeatability/reliability of the [18F]ACI-19626 brain uptake measures will be assessed by calculating the variability (percentage difference) of the tracer brain uptake between the first and the second [18F]ACI-19626 PET scan for each participant in study Part 3, and the mean will be calculated.
Measured: At the first [18F]ACI-19626 PET scan and the second [18F]ACI-19626 PET scan (i.e. up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start21 Jan 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal Dementia (FTD)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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Immune SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- Elsmarieke van de Giessen, MD, Principal investigator, Amsterdam UMCClinical Lead, Study director, AC Immune SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891716
- Sponsor's protocol ID
- ACI-19626-FTD-2301
- Other IDs
- 2024-513097-21-00
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate [18F]ACI-19626 as a Potential PET Radioligand for Imaging TDP-43 Inclusions in the Brain of Patients With Suspected TDP-43 Proteinopathies Compared With Healthy Controls
- ClinicalTrials.gov ID
- NCT06891716
- Acronym / sponsor ID
- ACI-19626-FTD-2301
- Conditions
- Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS), TDP-43 Proteinopathies, Suspected Limbic Predominant Age-related TDP-43 Encephalopathy (LATE), Alzheimer's Disease (AD)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- AC Immune SAIndustry (pharma, biotech, devices)
- Collaborators
- Amsterdam UMC, location VUmc
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 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 clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 [involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)] using a new positron emission tomography (PET) tracer called [18F]ACI-19626. Both healthy people and people with (suspected) TDP-43 accumulation will participate to this trial.
The main questions it aims to answer are:
- whether [18F]ACI-19626 is safe and well tolerated when injected into participants
- whether [18F]ACI-19626 reliably detects abnormal TDP-43 in the brain using PET technique.
- whether there are differences in the amount of this protein between people with diseases related to TDP-43 accumulation in the brain and people without these diseases.
Participants will:
- Visit the clinic to consent to their participation and to ensure they are eligible (physical and neurological examinations, questionnaires, blood and urine tests, ECG and MRI in some cases).
- Visit the clinic to receive the tracer [18F]ACI-19626 intravenously and be scanned in a PET scanner, during which blood will be collected.
- Receive a phone call from the clinic 2 to 4 days after the PET scan to report any symptoms and side-effects that they may be having.
Some of the participants may be asked to come again to the clinic for a second PET scan, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.
Detailed description
This trial aims to evaluate the effects (i.e. safety and uptake) of a new radiotracer molecule. Study participants will take part in the study by attending two to three study visits over a period of up to 3 months (from the screening visit up to the last study visit).
The study consists of three parts in which a total of up to 45 participants may be included:
Part 1 may include in total up to 15 participants:
- up to 5 healthy controls (HCs)
- up to 5 symptomatic progranulin gene (GRN) and up to 5 symptomatic chromosome 9 open reading frame 72 (C9orf72) mutation carriers with FTD (including prodromal) either with or without motor neuron disease (MND) characteristics.
If the safety and dosimetry are satisfactory in the first subjects and sufficient data are obtained from this part, Part 2 may be initiated.
Part 2 may include in total up to 30 participants including:
- up to 25 patients with TDP-43 proteinopathies: up to 10 additional mutation carriers (including other mutations than GRN and C9orf72, and/or asymptomatic carriers) with FTD (including prodromal) either with or without MND characteristics; up to 10 sporadic or genetic (excluding mutations with known absence of TDP-43 pathology, e.g. Superoxide Dismutase 1 (SOD1) or fused in sarcoma protein gene (FUS)) ALS; up to 10 suspected TDP-43 related sporadic FTD or FTD-MND; up to 5 patients with other neurodegenerative diseases, e.g. AD or suspected Limbic-Predominant Age-related TDP-43 Encephalopathy (LATE) pathology
- up to 5 additional HVs may also be imaged, if necessary, to enable a better distinction of brain binding in this population compared to the population of subjects with TDP-43 proteinopathies
Part 3 aims to assess test-retest reliability. Up to 5 participants from Part 1 and/or Part 2 will have an additional scan within 1 month after their first scan to determine test-retest reliability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with suspected TDP-43 proteinopathies | Experimental | Other: [18F]ACI-19626The study population will be composed of participants with suspected TDP-43 proteinopathies |
| Healthy controls | Active comparator | Other: [18F]ACI-19626The study population will be composed of healthy controls. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject is able to provide written informed consent (IC), which must be obtained before any assessment is performed.
- Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use reliable contraception method(s) and not donate eggs for 30 days after the PET scan. Subjects without documentation of non-childbearing potential will perform serum pregnancy testing at screening and urine pregnancy test before the PET scan. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the PI (e.g., Müllerian agenesis). Women of childbearing potential must commit to remain abstinent (refrain from heterosexual intercourse) or use a reliable form of birth control (e.g. a barrier, hormonal contraception method or intrauterine device), during the study and until 30 days after the last PET scan. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. Women of childbearing potential must commit to not donate ovum during the study and until 30 days after the last PET scan.
- Male subjects with their partners of childbearing potential must commit to the use of a barrier method of contraception during the study and until 90 days after the last PET scan.
- Male subjects must commit to not donate sperm during the study and until 90 days after the last PET scan.
- Willing and able to cooperate with study procedures.
Key exclusion criteria (17 listed)
- Current or prior history of any alcohol or drug abuse in the past 2 years.
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical condition.
- Known history of hypersensitivity, including hypersensitivity to the active substances used for [18F]ACI-19626 or derivatives, or to any of the associated excipients.
- Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit (including the procedures in this clinical protocol).
- Pregnant or lactating.
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 |
|---|---|---|
| [18F]ACI-19626[18F]ACI-19626 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of TDP-43 deposits. | Other | Healthy controls, Participants with suspected TDP-43 proteinopathies |
Primary outcome
Number of participants with Adverse Events (AEs) assessed by severity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Time frame: From Informed Consent Signature (screening) to safety phone call after PET scan (i.e. up to 3 months in total)
Number of participants with clinically significant changes in vital signs measurements
Time frame: During PET scan visit (i.e. at Day 0): before [18F]ACI-19626 injection and after the PET scan is completed
Vital signs measurements will be performed after the PET scan is completed and will be compared with measurements performed before the injection of [18F]ACI-19626.
Brain uptake of the tracer [18F]ACI-19626
Time frame: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
[18F]ACI-19626 brain uptake in relevant regions of interest of the brain will be measured with PET scan and the mean of each group (participants with TDP-proteinopathies and healthy controls) will be calculated.
Assessment of the optimal kinetic model quantification of [18F]ACI-19626 tracer uptake
Time frame: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
The selection of the optimal kinetic model will be done based on the Akaike's information criterion
Radiation dosimetry after one [18F]ACI-19626 PET scan
Time frame: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
The radiation dose absorbed by relevant vital organs and the total effective dose will be measured, and the mean of scanned participants will be calculated
2 secondary outcomes
Assessment of simplified methods to quantify brain uptake of the tracer [18F]ACI-19626
Time frame: At the time of the [18F]ACI-19626 PET scan (i.e. at Day 0): 0-90 minutes after injection
Variability of the tracer brain uptake between two [18F]ACI-19626 PET scans (test/retest)
Time frame: At the first [18F]ACI-19626 PET scan and the second [18F]ACI-19626 PET scan (i.e. up to 1 month)
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Frontotemporal Dementia (FTD)
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.
Elsmarieke van de Giessen, MD principal investigator
Amsterdam UMC
Clinical Lead study director
AC Immune SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]ACI-19626 in people with Frontotemporal Dementia (FTD) and Amyotrophic Lateral Sclerosis (ALS), run by AC Immune SA at 1 site 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 20 inclusion and 17 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 26 Aug 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) assessed by severity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related) (time frame: From Informed Consent Signature (screening) to safety phone call after PET scan (i.e. up to 3 months in total)). The study lists 5 primary outcomes in all. 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 26 Aug 2026.