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:

Healthy volunteers:

• People who give written agreement to take part before any screening begins, either personally or through a legally authorised representative.
• People who use a highly effective form of contraception, such as implants, injections, combined oral contraceptives, certain IUDs, complete abstinence from heterosexual intercourse during the trial period, or who have a vasectomised partner.
• Men or women aged 18–55 (Part I), 18–40 (Part II), or 40–70 (Part III, split into two age groups: 40–55 and 55–70).
• People who a doctor judges to be in good general health, based on medical history, physical examination, vital signs, blood tests, and urine tests.
• People with no history or current signs of a significant neurological, internal, or psychiatric condition, based on medical and psychological assessment.
• For Parts II and III only: people under 60 with a normal brain MRI, or people aged 60 and over with only minor age-related white matter changes on MRI that fall below a specific threshold (confirm with trial site).

People with Parkinson's disease:

• People aged 45–85.
• People with a clinically confirmed Parkinson's disease diagnosis according to Movement Disorder Society criteria, at a mild to moderate stage of the disease while on their regular medication.
• People who have previously had an abnormal DaT-scan that confirmed their Parkinson's disease diagnosis.
• People who are able to understand the participant information and give written consent to take part.

People with Alzheimer's disease:

• People aged 45–85.
• People with a score below 26 on a standard memory and thinking assessment called the MoCA.
• People with a confirmed diagnosis of probable Alzheimer's disease, supported by evidence from an amyloid PET scan or a cerebrospinal fluid test, according to recognised diagnostic guidelines.
• People who are able to understand the participant information and give written consent to take part.

People with ALS (amyotrophic lateral sclerosis):

• People aged 20–85.
• People being seen at the Neurology department of University Hospitals Leuven who meet recognised diagnostic criteria (revised El Escorial and Awaji-Shima criteria) for at least a possible ALS diagnosis.
• People who are able to understand the participant information and give written consent to take part.

Who may not be able to join:

Healthy volunteers:

• People with a history of a major illness that might interfere with the study or make participation unsafe, particularly diabetes, heart disease, liver or kidney disease, or most types of cancer.
• People currently using, or with a history of using, illicit drugs (including cannabis) or having a history of alcohol misuse.
• People who are currently taking part in another clinical trial involving an experimental medicine or medical device.
• People who show signs of cognitive (thinking or memory) impairment.
• People with a history or current evidence of a psychiatric condition.
• People with reduced kidney function below a specific level (eGFR under 60 ml/min).
• For Parts II and III only: people who cannot have an MRI scan for medical reasons.
• People with a known allergy or sensitivity to any ingredients in the radioactive imaging substances used in this trial, including the study drug [11C]HSP990.
• People who experience claustrophobia or are unable to lie still inside a scanner for at least 70 minutes.
• People who are unwilling to avoid strenuous or unusual physical activity (such as weightlifting, running, or cycling) from the pre-study visit through to the end of scanning.
• People who do not understand the study procedures.
• People considered unsuitable for any reason by the lead investigator, or who are unwilling or unable to complete all study procedures.
• People who are pregnant or breastfeeding.
• Women who are able to become pregnant and do not agree to use an effective method of contraception during the study and for at least 6 months after it ends (certain lower-effectiveness methods such as condoms used alone, spermicides, or natural methods are not accepted).
• Men whose partner is a woman who could become pregnant, if they do not agree to use a condom until 90 days after the study ends, and if their partner does not also use a highly effective method of contraception.
• People who do not agree to have any incidental health findings shared with their general practitioner and with themselves.
• For Parts II and III only: people with an abnormal Allen test result (a test of blood circulation in the hand) or a known allergy to the local anaesthetic lidocaine.
• For Parts II and III only: people on blood-thinning (anticoagulant) medication are not eligible for the parts of the study that involve taking blood from an artery, though they may still be able to take part in other parts of the study (confirm with trial site).

People with Parkinson's disease:

• People with psychiatric or neurological conditions other than Parkinson's disease.
• People with significant other medical conditions, particularly diabetes or heart disease.
• People with reduced kidney function below a specific level (eGFR under 60 ml/min).
• People whose MRI shows significant white matter changes (Fazekas score of 2 or higher) or other relevant abnormalities on brain imaging.
• People with a history of, or current, alcohol misuse (regularly drinking more than 15 units per week) or drug use.
• People who cannot have an MRI scan for medical reasons.
• People with a known allergy or sensitivity to any ingredients in the radioactive imaging substances used in this trial, including the study drug [11C]HSP990.
• People who experience claustrophobia or cannot lie still inside a scanner for at least 70 minutes.
• People who are unwilling to avoid strenuous or unusual physical activity from the pre-study visit through to the end of scanning.
• People who do not understand the study procedures, and who do not have a guardian who understands them.
• People considered unsuitable for any reason by the lead investigator, or who (or whose guardian) are unwilling or unable to complete all study procedures.
• People who do not agree to have any incidental health findings shared with their general practitioner and with themselves.
• People who are pregnant or breastfeeding.
• Women who are able to become pregnant and do not agree to use an effective method of contraception during the study and for at least 6 months after it ends (certain lower-effectiveness methods are not accepted).
• Men whose partner is a woman who could become pregnant, if they do not agree to use a condom until 90 days after the study ends, and if their partner does not also use a highly effective method of contraception.
• People on blood-thinning (anticoagulant) medication are not eligible for the parts of the study involving arterial blood sampling, though they may still be able to take part in other parts of the study (confirm with trial site).

People with Alzheimer's disease:

• The same exclusion criteria as listed above for Parkinson's disease apply.

People with ALS:

• The same exclusion criteria as listed above for Parkinson's disease apply.
• People whose condition involves only upper motor neuron symptoms (known as primary lateral sclerosis) or only lower motor neuron symptoms (known as progressive muscular atrophy) are not eligible.

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