Early Phase 1 Parkinson's 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:

For all participants:

• Participants must be able to give written consent before any assessments take place.
• Participants must be willing and able to follow all study procedures and requirements.
• Body mass index (a measure of body weight relative to height) must be between 18 and 31, and body weight must be between 50 kg and 100 kg.
• Female participants must either not be able to become pregnant, or must agree to use highly effective contraception during the study.
• For participants who will have a small tube placed in an artery, blood circulation to the hand must be adequate enough for this to be done safely (checked using a simple test called Allen's test).

For healthy volunteers (additional criteria):

• Participants must be male or female, aged 20 or older at the time of signing consent.
• Brain MRI scan and a type of brain imaging scan (DAT PET or SPECT) must show normal results, as judged by the study doctor (except for participants in Part 4 of the study).
• Participants must be in generally good health, based on medical history, physical checks, and laboratory test results, as judged by the study doctor.
• There must be no family history of conditions related to a protein called alpha-synuclein (such as Parkinson's disease), or other early-onset brain diseases linked to memory loss.
• There must be no personal history of any significant brain or mental health conditions.
• Participants must score 26 or higher on a standard memory and thinking test called the Montreal Cognitive Assessment (MoCA).
• Participants must have no signs of memory or thinking difficulties, as judged by the study doctor.

For participants with alpha-synuclein-related conditions (additional criteria):

• Participants must be male or female, aged 40 or older at the time of signing consent.
• Participants must have been diagnosed with one of the following conditions: Parkinson's disease (idiopathic), Parkinson's disease with a genetic risk factor (certain gene types only — confirm with trial site), Dementia with Lewy bodies (DLB), or possible or probable Multiple System Atrophy (MSA).
• Brain imaging (DAT PET or SPECT) must show a deficit in dopamine transporter activity, either from screening or from a previous scan done within the last 6 months, of sufficient quality as judged by the study doctor.
• Any medications taken to manage the diagnosed condition must have been at a stable dose for at least 30 days before the screening visit.

Who may not be able to join:

For all participants:

• Female participants who are pregnant, breastfeeding, or currently lactating.
• Participants who have psychiatric symptoms that could interfere with the study, as judged by the study doctor.
• Participants who have had a significant illness or health condition in the 6 months before screening that could affect the study or pose a risk, as judged by the study doctor.
• Participants who have had brain surgery or any surgical procedure on the brain or nervous system, or who have previously received a drug, antibody, or vaccine targeting alpha-synuclein.
• Participants with known or suspected drug or alcohol misuse, or a positive drug screen result that could interfere with the study, as judged by the study doctor.
• Participants with a history of severe allergic reactions, or who currently have significant allergies, as judged by the study doctor.
• Participants who are part of the team planning or running this study.
• Participants with a significant history of heart, blood vessel, lung, kidney, liver, brain, mental health, or digestive conditions, or any other major health condition that could interfere with the study, as judged by the study doctor.
• Participants whose brain MRI shows significant abnormalities (such as previous bleeding in the brain, stroke, or more than 3 small lesions), except for changes that are expected with Parkinson's disease, MSA, or DLB (applies to all except Part 4 participants).
• Participants who are taking blood-thinning or anti-clotting medications (except aspirin at 100 mg per day or lower) within 2 weeks of a planned arterial tube placement.
• Participants whose blood pressure at screening is above 150 mmHg (top number) or above 90 mmHg (bottom number) after at least 5 minutes of lying down (an average of three readings will be used if the first reading is high).
• Participants with a clinically significant heart rhythm abnormality on an ECG, including a specific measurement (QTc) greater than 450 milliseconds.
• Participants who have any reason they cannot safely have a brain MRI, DAT-SPECT, or PET scan — such as severe claustrophobia that cannot be managed, certain metal implants, or a known allergy to the scan substances — or who cannot lie still in a scanner for up to approximately 180 minutes (except for Part 4 participants, where some of these scans may not apply — confirm with trial site).
• Participants who have had significant previous radiation exposure for medical or other reasons, as judged by the study doctor.
• Participants who have taken part in another clinical trial involving an experimental treatment within 30 days, or within 5 times the elimination period of that treatment, whichever is longer.

For healthy volunteers (additional criteria):

• Participants currently taking medications that affect the brain or nervous system, such as antidepressants or antipsychotics (some anti-inflammatory or sleep medications may be permitted at the study doctor's discretion).
• Participants with a history of any neurological condition that could interfere with the study, as judged by the study doctor.

For participants with alpha-synuclein-related conditions (additional criteria):

• Participants whose medical history suggests a Parkinson's-like condition other than idiopathic Parkinson's disease — for example, progressive supranuclear palsy, medication-induced parkinsonism, essential tremor, vascular parkinsonism, primary dystonia, or corticobasal syndrome.
• Participants who are known carriers of certain Parkinson's-related gene mutations (specifically PRKN, PINK1, DJ1, or LRRK2), based on previous medical records.

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