Phase 2 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:

• Men, or women who are either past menopause, have had a hysterectomy or bilateral tubal ligation, or are using at least one approved method of contraception from at least 30 days before the study starts until at least 150 days after the last dose of the study drug
• People who have been diagnosed with idiopathic REM Sleep Behavior Disorder (iRBD) — a sleep condition where a person acts out their dreams — confirmed by a sleep study showing abnormal muscle activity during REM sleep
• People who have a reduced sense of smell, defined by a score below the 15th percentile for their age and gender on a standardised smell test
• People who have not been diagnosed with movement symptoms of Parkinson's disease or Lewy body dementia
• People who score above 23 on the MoCA memory and thinking test at both the screening and baseline visits
• People who can speak, read, and write fluently in the official language used at the trial site
• People who are willing and able to attend all required study visits
• People who have a study partner — someone in regular contact with them who can attend clinic visits and report on how they are functioning day to day
• People who can self-inject the study drug regularly, or who have a study partner willing and able to do so
• People who are able to understand what the study involves and sign a written consent form

Who may not be able to join:

• People whose REM Sleep Behavior Disorder has an identifiable cause other than the idiopathic form, such as narcolepsy
• People who have another neurological or medical condition that may affect thinking or memory, such as a history of serious head injury, seizure disorder, hydrocephalus, brain infection, brain tumour, or significant metabolic or endocrine disorder
• People whose brain MRI shows more than three small stroke-related lesions, a larger stroke or bleed, or severe white matter changes (Fazekas score of 3), as assessed by the central imaging reviewer
• People who cannot have an MRI scan — for example, due to a pacemaker, certain metal implants or foreign objects in the body, a history of claustrophobia, or inability to tolerate the scanning procedure
• People with a history of or currently living with any of the following: a large stroke; a nerve-insulating disease such as multiple sclerosis; serious or recurring infections; a heart attack or unstable chest pain within the past 12 months; significant abnormalities on a heart rhythm test (ECG), including a prolonged QT interval; moderate to severe heart failure; an autoimmune disease such as lupus, rheumatoid arthritis, Type 1 diabetes, inflammatory bowel disease, or psoriasis; a condition or medication that significantly weakens the immune system; current or past hepatitis B infection (confirm with trial site for specific antibody result exceptions); untreated or incompletely treated tuberculosis or a positive TB blood test; a positive hepatitis C antibody test without confirmed successful treatment; a positive HIV test; a history of most cancers (certain successfully treated skin cancers and cervical carcinoma in situ may be exceptions — confirm with trial site); a severe depressive episode requiring new medication or hospitalisation within the past 90 days; consistently high blood pressure above 150/90 on three separate readings; hallucinations or delusions; or a psychiatric condition involving psychosis such as schizophrenia
• People who have had an active infection requiring intravenous antibiotics within the past 30 days, or oral or injected antibiotics within the past 14 days
• People who have had major surgery within 12 weeks of the screening visit
• People who have donated blood within 8 weeks before the first dose of the study drug
• People with certain abnormal blood test results at screening, including low haemoglobin (below 12 g/dL for men or 11 g/dL for women), significantly elevated liver or muscle enzymes on two tests taken within two weeks, kidney function below a certain level, or abnormal blood clotting results
• People who have any other significant medical condition that the investigator believes would make participation unsafe
• People who have a reason they cannot safely have a lumbar puncture (spinal fluid test), such as significant spinal abnormalities, very low platelet count, or use of blood thinners — this applies only to participants who agree to the optional lumbar puncture procedure
• People currently taking or who have previously taken certain medications, including: anti-Parkinson's drugs (such as levodopa or dopamine agonists) at any time before screening; cognitive enhancers (such as donepezil or memantine) at any time before screening; stimulant medications at any time before screening; antipsychotic medications including pimavanserin; antidepressants at an unstable dose within the past 90 days; immune-suppressing medications within the past 12 months; or any previous injected or infused antibody-based therapies (such as anti-TNF biologics, rituximab, or similar treatments)
• People who have received a live vaccine (with some exceptions) within 30 days before the first dose, or who expect to need one during the study period or within 70 days after the last dose
• People who have had an allergic or significant sensitivity reaction to adalimumab or related medications
• People currently participating in another interventional clinical trial, or who have taken an investigational drug within 30 days (or within 5 half-lives of that drug) before screening
• People with a history of drug or alcohol misuse, including cannabis use disorder, within the past five years
• People who test positive for drugs of misuse at the screening urine test
• People who are unwilling or unable to follow the study requirements, including self-administering the study medication, or who have a documented history of not complying with clinical trial requirements

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