Early Phase 1 Motor Neurone Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

All participants must meet these criteria:

• People who are able to give written consent before any study assessments begin.
• Women who are not able to become pregnant, or who agree to use reliable contraception and not donate eggs for 30 days after the PET scan (pregnancy testing will be required for those without documented proof of non-childbearing status).
• Men whose partners could become pregnant must agree to use barrier contraception during the study and for 90 days after the last PET scan.
• Men must agree not to donate sperm during the study and for 90 days after the last PET scan.
• People who are willing and able to follow the study procedures.
• People who are able to lie still in a scanner for up to 90 minutes (or up to 120 minutes with a break if needed), without moving in a way that would affect the scan images.
• For those having an arterial line placed: people who have adequate blood circulation in the hand and whose blood clotting tests are within acceptable ranges.

Healthy volunteers must also meet these criteria:

• Men and women aged between 40 and 70 years.
• People who are in good health with no significant findings on physical or neurological examination at the start of the study and at the time of the imaging visit.
• People with no family history of TDP-43-related brain diseases, including frontotemporal dementia (FTD), ALS, or other early-onset neurological conditions linked to dementia or movement problems.
• People with no personal history of significant neurological or psychiatric conditions.
• People with no signs of brain degeneration or other neurological abnormalities on a brain MRI scan taken either at screening or within the past 6 months.
• People who score 26 or higher on a standard memory and thinking test called the Montreal Cognitive Assessment (MoCA).
• People who show no signs of problems with thinking or behaviour, as assessed by the study doctor.

People with TDP-43-related brain diseases must also meet these criteria:

• Men and women aged 40 years or older.
• People diagnosed with one of the following conditions: a genetic mutation (such as GRN or C9orf72) linked to frontotemporal dementia with a disease severity rating of 0.5 or above on a recognised scale; a non-genetic (sporadic) form of behavioural frontotemporal dementia or primary progressive aphasia, with or without signs of motor neuron disease; ALS meeting recognised diagnostic criteria of probable or possible ALS; or other neurodegenerative diseases such as Alzheimer's disease or a condition suspected to involve a particular protein called TDP-43.
• People with a genetic form of FTD or ALS must have confirmed genetic test results.
• People with non-genetic FTD must have a brain MRI consistent with an FTD diagnosis, with no evidence of another condition that could better explain their symptoms.

Who may not be able to join:

All participants are excluded if they meet any of these criteria:

• People with a current or past history of alcohol or drug misuse in the last 2 years.
• People with significantly abnormal laboratory test results or an unstable medical condition.
• People with a known allergy or sensitivity to the imaging agent used in this study ([18F]ACI-19626) or any of its ingredients.
• People whose participation in other research or medical procedures in the past year has already resulted in radiation exposure at or above the acceptable yearly limit.
• People who are pregnant or breastfeeding.
• People with significant ongoing disease affecting the digestive system, heart, liver, kidneys, blood, hormone system, immune system, lungs, or other organs.
• People with veins that are not suitable for repeated blood draws.
• People with certain medical implants not certified as safe for MRI (such as pacemakers, defibrillators, insulin pumps, cochlear implants, metal fragments in the eye, nerve stimulators, or brain aneurysm clips), or people with a history of claustrophobia in MRI scanners.
• People who have taken blood-thinning medications (such as warfarin, heparin, or similar drugs) within 2 weeks of a planned arterial line procedure.
• People with clinically significant anaemia, as assessed by the study doctor (applies to those undergoing arterial cannulation).
• People with blood clotting disorders.
• People who have lost or donated more than 500 mL of blood in the four months before the study visits (applies to those undergoing arterial cannulation).
• People who have taken an experimental drug within the last 30 days or within 5 half-lives of that drug (whichever is longer) before screening, unless there is documented evidence they received only a placebo.

People with TDP-43-related brain diseases are also excluded if:

• They have previously taken part in a clinical trial of a disease-modifying treatment that could affect TDP-43 protein or its processing (such as gene therapy), unless documented evidence confirms they received only a placebo.
• Their brain MRI shows evidence of a different condition that is not consistent with TDP-43-related disease and could explain their symptoms.
• They carry a genetic mutation known not to be associated with TDP-43 abnormalities, such as SOD1 or FUS mutations.

Important: Always verify eligibility with the trial site directly before applying.