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New treatment option for Frontotemporal Dementia (FTD)
Official title [18F]ACI-19626 PET in TDP-43 Proteinopathies
ClinicalTrials.gov ID: NCT06891716
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70. Healthy volunteers may be eligible.
You may be able to join if
- for all Participants:
- Subject is able to provide written informed consent (IC), which must be obtained before any assessment is performed.
- Female people must not be of childbearing potential, or if they are of childbearing potential to agree to use reliable contraception method(s) and...
- Male people with their partners of childbearing potential must commit to the use of a barrier method of contraception during the study and until 90...
- Male people must commit to not donate sperm during the study and until 90 days after the last PET scan.
You likely can't join if
- for All Participants:
- 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...
- Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective...
- Pregnant or lactating.
See the full eligibility criteria
Who can join
- for all Participants:
- Subject is able to provide written informed consent (IC), which must be obtained before any assessment is performed.
- Female people 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. people without...
- Male people 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 people 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.
- For people 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...
- 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 for Participants with TDP-43 proteinopathies:
- Males and females aged ≥ 40 years.
- people diagnosed with any of the following: GRN, C9Orf72 or other mutation carriers with the CDR® plus NACC FTLD-GS of ≥ 0.5; sporadic probable behavioral FTD per International consensus criteria or primary progressive...
- Confirmed genetic status for the people with genetic FTD, FTD-MND or ALS (e.g. GRN, C9orf72 or other mutations)
- For sporadic FTD / FTD-MND people: 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.
What rules you out
- for All Participants:
- 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...
- Pregnant or lactating.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- 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...
- 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...
- Anaemia (for people 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 people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.