Phase 2 Parkinson's Disease Trial, Not Yet Recruiting

• People aged 40 to 75 years old who have been diagnosed with Parkinson's disease (PD) or a related condition called a Parkinson's-plus syndrome (PPS), which includes Dementia with Lewy Bodies (DLB), Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), or Corticobasal Degeneration (CBD) with movement symptoms.
• People whose diagnosis of PD or PPS was documented 6 years ago or less.
• People who, in the treating doctor's opinion, are expected to live for at least 3 more years.
• People who are willing and able to give informed consent to participate.
• People who are able to follow the study's requirements over the full 18-month period.
• People whose overall health has been stable for at least 60 days before the first screening appointment.
• People who are able to walk at least 25 metres without help from another person or a walking aid.
• People with no known history of a condition called heparin-induced thrombocytopenia (a serious reaction to a blood-thinning medication).

For Parkinson's disease specifically, people may also need to meet these criteria:

• People diagnosed with idiopathic (no known cause) Parkinson's disease who meet the Movement Disorder Society's (MDS) clinical diagnostic criteria for PD.
• People whose PD symptoms improve by at least 33% when taking levodopa or dopamine agonist medications, as measured by a standardised assessment tool (MDS-UPDRS-III).
• People at a modified Hoehn and Yahr stage of 3 or below, which is a scale used to measure how advanced Parkinson's symptoms are.
• People whose brain imaging results are consistent with PD and do not show unusual changes unrelated to PD.
• People with a score of 26 or higher on a standard memory and thinking test called the Montreal Cognitive Assessment (MoCA), indicating normal cognition.

For Dementia with Lewy Bodies (DLB) specifically, people may also need to meet these criteria:

• People with a MoCA score of 23 or higher, suggesting sufficient thinking ability to give informed consent.
• People with a probable DLB diagnosis based on established criteria, meaning either two or more core features are present, or one core feature plus at least one supportive test result (biomarker).
• Core features may include: noticeable fluctuations in alertness and attention; recurring, detailed visual hallucinations; or a sleep disorder called REM sleep behaviour disorder (acting out dreams).
• People who show at least one key Parkinson's-like movement symptom, such as slowness of movement, a resting tremor, or muscle stiffness.
• Supportive test results (biomarkers) may include: reduced dopamine transporter activity in the brain shown by a SPECT or PET scan; abnormal heart imaging results using a specific scan (I-MIBG myocardial scintigraphy); or a sleep study confirming a specific pattern during REM sleep.

For Progressive Supranuclear Palsy (PSP) specifically, people may also need to meet these criteria:

• People who meet the MDS diagnostic criteria for probable PSP with predominantly Parkinsonian features (PSP-P).
• People who show specific eye movement problems, such as difficulty looking up or down, very slow eye movements in the vertical direction, or frequent involuntary eye jerks or difficulty opening the eyelids.
• People who show a combination of eye movement problems and movement symptoms, which may include stiffness, slowness, poor response to levodopa, or other features (confirm with trial site).
• People with a MoCA score of 26 or higher.

For Multiple System Atrophy (MSA) specifically, people may also need to meet these criteria:

• People who meet the MDS diagnostic criteria for clinically probable MSA.
• People who show signs of the autonomic nervous system not working properly (for example, problems with blood pressure, bladder, or sweating).
• People who show Parkinson's-like movement symptoms.
• People who show signs of cerebellar dysfunction, including at least one of: unsteady walking, uncoordinated limb movements, slurred speech related to the cerebellum, or certain eye movement problems.
• People with a MoCA score of 26 or higher.

For Corticobasal Degeneration (CBD) with parkinsonism specifically, people may also need to meet these criteria:

• People whose condition has developed slowly and progressively over time.
• People whose symptoms began on one side of the body before affecting the other.
• People who show signs of higher brain function problems, such as difficulty with purposeful movements (apraxia), speech difficulties, language problems, a limb that feels as though it moves on its own (alien limb), or loss of sensation in the skin.
• People who show movement problems including stiffness or slowness, and either abnormal limb posturing or small, sudden muscle jerks in a limb, and whose symptoms do not respond to levodopa.
• People with a MoCA score of 26 or higher.