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 healthy volunteers (general group):

• People aged 50 to 85 years, male or female
• People who are able to give their informed consent to participate
• People who have good enough vision and hearing to complete memory and thinking tests
• People with no current or past significant brain or mental health conditions
• People with a moderate level of depression, as measured by a standard questionnaire score of 20 or above
• People with no current or past inflammatory or autoimmune conditions (conditions where the immune system attacks the body)
• People with no family history of brain-wasting (neurodegenerative) diseases
• People whose memory and thinking are considered normal for their level of education, based on a standard screening test score of 26 or above
• Women who are surgically sterile, have been through menopause for at least one year, or commit to using highly effective contraception throughout the study and for at least six months after their brain scan
• Men and their partners who are able to become pregnant must commit to using highly effective contraception during the study and for at least three months after each brain scan
• Men who commit to not donating sperm during the study and for at least three months after the last brain scan
• People who commit to avoiding alcohol for 48 hours before each visit, avoiding caffeine for 12 hours before brain scanning visits, and avoiding smoking or nicotine products on the day of brain scans
• People who commit to not donating blood for up to three months after the last brain scan
• People who commit to arriving at their screening and first study visit having not eaten for at least 8 hours
• People who commit to avoiding over-the-counter anti-inflammatory pain medicines (such as ibuprofen) and alcohol for 48 hours before the screening visit

For people with Parkinson's disease:

• People aged 50 to 85 years, male or female
• People who are able to give their informed consent to participate
• People who have good enough vision and hearing to complete memory and thinking tests
• People with no other significant brain or mental health conditions beyond their Parkinson's diagnosis
• People who have a confirmed diagnosis of Parkinson's disease based on recognised medical diagnostic criteria
• People with Parkinson's disease who have not yet started any medication for it must be treatment-free at the time of joining the study
• People with Parkinson's disease who also have mild thinking or memory difficulties, confirmed by recognised diagnostic criteria and/or a standard test score below 23
• People with Parkinson's disease who are taking dopamine-based medication must have been on a stable dose for at least 60 days before joining
• Women who are surgically sterile, have been through menopause for at least one year, or commit to using highly effective contraception throughout the study and for at least six months after their brain scan
• Men and their partners who are able to become pregnant must commit to using highly effective contraception during the study and for at least three months after each brain scan
• Men who commit to not donating sperm during the study and for at least three months after the last brain scan
• People who commit to avoiding alcohol for 48 hours before each visit, avoiding caffeine for 12 hours before brain scanning visits, and avoiding smoking or nicotine products on the day of brain scans
• People who commit to not donating blood for up to three months after the last brain scan
• People who commit to arriving at their screening and first study visit having not eaten for at least 8 hours
• People who commit to avoiding over-the-counter anti-inflammatory pain medicines and alcohol for 48 hours before the screening visit

For people with isolated REM sleep behaviour disorder (iRBD — a sleep condition involving acting out dreams):

• People aged 40 to 85 years, male or female
• People who are able to give their informed consent to participate
• People who have good enough vision and hearing to complete memory and thinking tests
• People with no current or past significant brain or mental health conditions
• People with a moderate level of depression, as measured by a standard questionnaire score of 20 or above
• People with no current or past inflammatory or autoimmune conditions
• People with no family history of brain-wasting (neurodegenerative) diseases
• People whose memory and thinking are considered normal for their level of education, based on a standard screening test score of 26 or above
• Women who are surgically sterile, have been through menopause for at least one year, or commit to using highly effective contraception throughout the study and for at least six months after their brain scan
• Men and their partners who are able to become pregnant must commit to using highly effective contraception during the study and for at least three months after each brain scan
• Men who commit to not donating sperm during the study and for at least three months after the last brain scan
• People who commit to avoiding alcohol for 48 hours before each visit, avoiding caffeine for 12 hours before brain scanning visits, and avoiding smoking or nicotine products on the day of brain scans
• People who commit to not donating blood for up to three months after the last brain scan
• People who commit to arriving at their screening and first study visit having not eaten for at least 8 hours
• People who commit to avoiding over-the-counter anti-inflammatory pain medicines and alcohol for 48 hours before the screening visit

Who may not be able to join:

For healthy volunteers and Parkinson's disease patients (general exclusions):

• People who are unwilling or unable to follow the study procedures
• People with a current or recent history (within the past 12 months) of drug or alcohol misuse or dependence
• People with a moderate or higher level of depression, as measured by a standard questionnaire score of 20 or above (note: this is also listed as a requirement for some groups — confirm with the trial site)
• People with significant abnormal results on blood or urine safety tests, as determined by the study doctor
• People with other health conditions or who take medications that the study doctor considers incompatible with the study assessments or brain scans
• People who have used antipsychotic medicines or corticosteroids (strong anti-inflammatory medicines) within the past 30 days
• People who have used over-the-counter anti-inflammatory pain medicines (such as ibuprofen) within the past 2 days
• People who have used long-acting sedative medicines (such as diazepam) or medium- to slow-acting sedative medicines at higher doses within the past 30 days before their first brain scan
• People who carry a specific genetic variation (called rs6971 low-affinity binder) that would interfere with a particular type of brain scan used in the study (confirm with trial site)
• People with known brain conditions such as stroke, bleeding in the brain, tumours, or signs of brain inflammation
• People whose blood tests show signs of HIV, syphilis, COVID-19, or viral hepatitis
• People with a history of fainting episodes, abnormal responses to changes in body position, a slow heart rate, or who take medicines that slow the heart rate (such as beta-blockers)
• People who are pregnant or breastfeeding
• People who cannot have an MRI scan due to metal devices or implants in the body, metal deposits in the body, or metal fragments in the eyes
• People who have had cancer in the past 5 years, with some exceptions for certain early-stage or treated skin, prostate, cervical, or uterine cancers
• People with claustrophobia (fear of enclosed spaces) or back pain that would make lying in a scanner for an extended period unbearable
• People for whom a small tube cannot be safely placed in an artery, for example due to a history of bleeding problems
• People who do not have adequate blood flow through the hand on a specific circulation test called an Allen's test (confirm with trial site)
• People who have had an infection or vaccination within the past 30 days
• People who are currently taking part in another clinical trial involving an experimental medicine

Additional exclusions for people with iRBD:

• People who take certain medicines that can interfere with a specific type of brain scan measuring dopamine activity (including medicines such as methylphenidate, cocaine, amphetamines, modafinil, bupropion, certain antipsychotics, metoclopramide, and others — confirm the full list with the trial site)
• People whose brain scan (a type called dopamine transporter SPECT) shows reduced dopamine activity in a specific part of the brain

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