Phase 4 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:

Arm 1 – People with Lewy body or Parkinson's-related cognitive conditions:

• People aged 50 to 89 years old
• People who have been diagnosed with dementia with Lewy bodies (DLB), Parkinson's disease dementia (PDD), Parkinson's disease with mild thinking and memory changes (PD-MCI), or mild cognitive impairment with Lewy bodies (MCI-LB)
• The diagnosis must meet specific established medical criteria for each condition (confirm with trial site)
• People who are able to give their own consent to participate, or who have a legally authorised representative or guardian who can give consent on their behalf
• People with a dementia diagnosis must have an informant (such as a family member or carer) available who knows them well
• People who are willing and able to follow all study procedures
• People who are fluent in spoken and written English, as the study includes cognitive testing

Arm 2 – People joining the cholinesterase inhibitor (medication) part of the study:

• People who have already completed Arm 1 of this trial
• People who have a clinical diagnosis of Lewy body dementia (DLB or PDD) with a specific feature called cognitive fluctuations (confirm with trial site)
• People who are not currently taking a cholinesterase inhibitor medication, and have not taken one in the past 90 days
• People who are willing and able to follow the procedures for this part of the study, including taking the medication galantamine, or who have a carer willing and able to help ensure they take it correctly

Arm 3 – Healthy volunteers:

• People aged 50 to 89 years old
• People who do not have any known neurological conditions that could interfere with the study
• People who are able to give their own consent to participate, or who have a legally authorised representative or guardian who can give consent on their behalf
• People who are willing and able to follow all study procedures
• People who are fluent in spoken and written English, as the study includes cognitive testing

Who may not be able to join:

Arm 1:

• People who have a history of a cognitive or psychiatric condition that is not related to Lewy body dementia or Parkinson's disease
• People who have had deep brain stimulation or any brain surgery in the past
• People who have a history of a structural brain condition or significant disease affecting the blood vessels in the brain
• People who have a history of seizures or epilepsy, or who take certain seizure medications including carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, or valproate
• Men who regularly drink more than two alcoholic drinks per day, or women who regularly drink more than one alcoholic drink per day
• People who regularly use benzodiazepines (such as sleeping tablets or anxiety medications) or barbiturates; people who take these only occasionally must not take them within a certain time window around study visits (confirm timing with trial site)
• People whose dementia is considered severe, based on how much help they need with everyday tasks (as assessed by the study doctor)
• People who are unable to have a brain MRI scan for any reason
• People who have any medical condition that would prevent them from completing all study procedures
• People who are pregnant, planning to become pregnant, or planning to father a child during the study

Arm 2:

• People who have severe liver problems
• People who have kidney failure
• People who have a significantly slow heart rate (fewer than 50 beats per minute) at the screening visit, or who have a history of a specific type of heart rhythm problem called AV block
• People for whom the study doctor determines there is any other reason the medication galantamine should not be given

Arm 3 – Healthy volunteers:

• People who have a history of a cognitive or psychiatric condition
• People who have had deep brain stimulation or any brain surgery in the past
• People who have a history of a structural brain condition or significant disease affecting the blood vessels in the brain
• People who have a history of seizures or epilepsy, or who take certain seizure medications including carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, or valproate
• People who have any medical condition that would prevent them from completing all study procedures
• People who are pregnant, planning to become pregnant, or planning to father a child during the study

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