Phase 2 Motor Neurone Disease Trial, Recruiting

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

Who might be able to join this trial:

General requirements for all participants:

• A person must be able to understand and sign the consent and privacy forms before any study procedures begin
• Women who cannot become pregnant must have had a sterilisation procedure (such as removal of the uterus, fallopian tubes, or ovaries) at least 26 weeks before the screening visit, or must have had no menstrual periods for at least 2 years with hormone levels confirming menopause
• Women who could become pregnant, and all men, must agree to abstain from sexual intercourse or use an approved form of contraception during the study and for a set period afterwards (90 days for men, 6 months for women)
• Male participants must agree not to donate sperm for 90 days after the first study visit
• Women must not be pregnant, breastfeeding, or nursing at any point during the study
• Women who could become pregnant must have a negative pregnancy test at both the screening visit and the check-in visit
• Kidney function must be above a certain level, as measured by a standard blood test (eGFR greater than 45 mL/min/1.73m²)
• A blood inflammation marker called C-reactive protein must be at or below 10 mg/dL
• Participants must be willing and able to follow all study rules and attend all required visits

For people with ALS (Motor Neurone Disease):

• Adults aged 18 to 80 at the screening visit
• A diagnosis of sporadic or familial ALS that meets recognised medical diagnostic standards (modified El Escorial criteria), at any level of diagnostic certainty from "possible" to "definite"
• Lung capacity (FVC) must be at least 50%, or the person must be able to lie flat for up to 90 minutes — lung test results from the past 6 months may be accepted at the doctor's discretion
• Any changes to ALS medications in the 30 days before the screening visit must be discussed with the study medical team

For people with Alzheimer's disease (AD):

• Adults aged 40 to 80 at the screening visit
• A clinical diagnosis of early-stage Alzheimer's-type dementia, supported by specific brain scan (PET) results or biological markers in blood or spinal fluid, consistent with 2018 research guidelines
• A score of more than 20 on the MMSE memory and thinking test at screening
• Any changes to Alzheimer's medications in the 30 days before the screening visit must be discussed with the study medical team

For people with Multiple Sclerosis (MS):

• Adults aged 18 to 70 at the screening visit
• Any changes to MS medications in the 30 days before the screening visit must be discussed with the study medical team

For relapsing-remitting MS (RRMS):

• A diagnosis of RRMS based on 2017 McDonald diagnostic criteria
• If not newly diagnosed, at least one documented relapse in the past 24 months
• For those with "active disease": at least one area of active inflammation visible on a special type of MRI brain or spinal cord scan at screening
• For those with "disease in remission": no active inflammation on MRI, and stable symptoms for at least 3 months before the first study visit
• A disability score (EDSS) between 2.0 and 5.5 at screening

For progressive MS (PPMS or SPMS):

• A diagnosis of primary or secondary progressive MS based on 2017 McDonald criteria
• A disability score (EDSS) between 3.0 and 6.5 at screening
• No relapses in the 6 months before the study
• Stable neurological symptoms for at least 30 days before the first study visit
• Documented evidence of increasing disability over the past 24 months that was not caused by a relapse

For people with Parkinson's disease (PD):

• Adults aged 55 to 80 at the screening visit
• A confirmed diagnosis of typical, idiopathic (no known cause) Parkinson's disease based on UK Parkinson's Society Brain Bank criteria
• Any changes to Parkinson's medications in the 30 days before the screening visit must be discussed with the study medical team

Who may not be able to join:

General exclusions for all participants:

• Body weight over 120 kg
• A significant past or current medical condition affecting the blood, kidneys, hormones, lungs, heart, digestive system, liver, mental health, immune system, or allergies that the doctor believes could interfere with the study drug or put the person at unacceptable risk
• A history of recurring kidney or liver cancer
• A pacemaker, defibrillator, or any non-removable metal implant in the body that is not safe for MRI scans
• Being unable to lie still in a PET/CT or PET/MRI scanner for up to 90 minutes at a time
• Abnormal blood or urine test results at screening or check-in that the doctor considers clinically significant, including liver enzyme levels (AST or ALT) more than three times the upper limit of normal
• A recent acute illness considered significant by the doctor, within 10 days before the screening visit
• A history of alcohol or drug misuse within the past 2 years, or use of cannabis products within 10 days before the first study visit
• A positive drug, marijuana, or nicotine test at screening or check-in
• Having received any vaccine within 28 days before screening
• Having taken part in another clinical drug study within 30 days, or within 5 half-lives of that drug (whichever is longer), before the first study visit
• Having taken corticosteroid medicines (such as prednisone or methylprednisolone) within 30 days before the start of the study
• Having taken certain anti-inflammatory medicines (NSAIDs, including carboxylic acids, enolic acids, or COX-II inhibitors) within 14 days before the first study visit
• Having donated or lost more than 450 mL of blood within 30 days before screening
• MRI scan findings that could interfere with imaging results, such as significant blood vessel disease in the brain, infection, tumours, fluid build-up in the brain, or other abnormalities unrelated to the condition being studied
• Metal implants or medical devices that could interfere with CT scan image quality
• The doctor has reason to believe the person may not be able to complete all required study visits
• Any finding that, in the opinion of the doctor and medical team, could put the person's safety at risk during the trial

For people with MS:

• Signs or test results suggesting a different condition called neuromyelitis optica (NMO) spectrum disorder or MOG-associated encephalomyelitis, including the presence of certain antibodies in the blood
• A diagnosis of progressive multifocal leukoencephalopathy (PML), a serious brain condition

For people with Parkinson's disease:

• A form of parkinsonism that is caused by another condition, is classified as atypical, or has a known genetic cause

For healthy volunteers (if applicable):

• A clinically relevant finding on physical examination at screening
• A family history of neurological disease that could affect how brain scan images are interpreted
• A personal history of any brain or nervous system disorder, or brain injury, that could cause abnormalities on imaging scans

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