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The Presence Study- Studying the Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson's Disease Dementia (PDD)
Investigational Medication for Memory and Thinking Problems in Parkinson's Disease Dementia
Recruiting
40 years - 85 years
All
Phase
N/A
1 Location
Brief description of study.
The purpose of this study is to determine how LY3154207 compares with placebo in treating memory and thinking problems in individuals with mild-to-moderate Parkinson?s disease dementia.
Detailed description of study
The primary objective is to test the hypothesis that LY3154207 administered at 10 mg, 30 mg, and/or 75 mg daily (or 50 mg based on interim analysis) (QD) oral dosing for 12 weeks will result in significant improvement in cognition in subjects with mild-to-moderate Parkinson's Disease Dementia (PDD) compared with placebo.
Participants will be paid for their participation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Parkinson's and memory,Parkinson's dementia,Parkinson's disease,Parkinson's disease dementia
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Age: 40 years - 85 years
-
Gender: All
Inclusion Criteria
Have idiopathic PD per MDS criteria with at least 2 years of PD symptoms
Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment
If on anti-parkinsonian agents, subjects must be on stable dosage for at least 4 weeks prior to Visit 2, and it is anticipated that no changes will be needed during the course of the study
If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), subjects must be on stable dosage for at least 8 weeks prior to Visit 2 and expected to remain at a stable dosage during the course of the study
If on antidepressant medications, subjects must be on stable dosage for at least 8 weeks prior to Visit 2 and expected to remain on stable dosage during the course of the study
If on clozapine, quetiapine, and pimavanserin to address drug-induced or disease-related psychosis, subjects must be on a stable dosage for 4 weeks prior to Visit 2 and expected to remain at a stable dosage during the course of the study
If on antihypertensive medications, subjects must be on stable dosage for at least 3 months prior to Visit 1
Are able to swallow capsules
All subjects must have a reliable caregiver who is in frequency contact with the subject (defined as at least 10 hours per week) and will accompany the subject to Visit 1, Visit 2, Visit 4, Visit 8, Visit 11 and Visit 801
Agree not to post any personal medical data related to the study or information related to the study on any website or social media (eg, Facebook, Twitter, LinkedIn, Google+, etc.)
Exclusion Criteria
Are WOCBP
Have significant central nervous system disease, other than PD, that may affect cognition or the ability to complete the study, including but not limited to other dementias (eg, Alzheimer's disease [AD})
Have a history in the last 6 months of transient ischemic attacks or ischemic stroke
Have a history of intra-cerebral hemorrhage due to hypertension
Have a history of hypertensive encephalopathy
Have atypical or secondary parkinsonism due to drugs (eg, antipsychotics) or disease (such as progressive supranuclear palsy, essential tremor, multiple system atrophy [eg, striatonigral degeneration, olivopontocerebellar atrophy], or postencephalitic parkinsonism)
Have a current implantable intracranial stimulator or history of intracranial ablation surgery (eg, subthalamic, globus pallidus-internal segment)
Have a current or any previous diagnosis of bipolar disorder, schizophrenia, or other primary psychotic disorder
Have poorly controlled psychosis (hallucinations or delusions) that in the opinion of the investigator would interfere with the subject's ability to be compliant with the study protocol
Have any other psychiatric disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol
Have a serious or unstable medical illness, other than idiopathic PD, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality as determined by the investigator.
Subjects with acute liver disease
Have used antipsychotic medications, with the exception of clozapine, quetiapine, pimavanserin in the 6 months prior to screening (Visit 1) and at any time during the course of the study
Have used trihexphenidyl and benztropien in the 4 weeks prior to screening (Visit 1) and at any time during the course of the study
Have a motor conditions for which the antiparkinsonian teratment is expected to change during the course of the study, as well as unpredictable motor fluctuations that in the investigator's opinion would interfere with conducting assessments
Are currently taking any medications or food, herbal or dietary supplements that are inhibitors (eg, ketoconazole, grapefruit juice), or strong/moderate inducers of cytochrome P450 3A4 (CP3A4) (eg, rifampicin)
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 3 months, in a clinical study involving an interventional product or device
Have previously been exposed to LY3154207
Have idiopathic PD per MDS criteria with at least 2 years of PD symptoms
Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment
If on anti-parkinsonian agents, subjects must be on stable dosage for at least 4 weeks prior to Visit 2, and it is anticipated that no changes will be needed during the course of the study
If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), subjects must be on stable dosage for at least 8 weeks prior to Visit 2 and expected to remain at a stable dosage during the course of the study
If on antidepressant medications, subjects must be on stable dosage for at least 8 weeks prior to Visit 2 and expected to remain on stable dosage during the course of the study
If on clozapine, quetiapine, and pimavanserin to address drug-induced or disease-related psychosis, subjects must be on a stable dosage for 4 weeks prior to Visit 2 and expected to remain at a stable dosage during the course of the study
If on antihypertensive medications, subjects must be on stable dosage for at least 3 months prior to Visit 1
Are able to swallow capsules
All subjects must have a reliable caregiver who is in frequency contact with the subject (defined as at least 10 hours per week) and will accompany the subject to Visit 1, Visit 2, Visit 4, Visit 8, Visit 11 and Visit 801
Agree not to post any personal medical data related to the study or information related to the study on any website or social media (eg, Facebook, Twitter, LinkedIn, Google+, etc.)
Exclusion Criteria
Are WOCBP
Have significant central nervous system disease, other than PD, that may affect cognition or the ability to complete the study, including but not limited to other dementias (eg, Alzheimer's disease [AD})
Have a history in the last 6 months of transient ischemic attacks or ischemic stroke
Have a history of intra-cerebral hemorrhage due to hypertension
Have a history of hypertensive encephalopathy
Have atypical or secondary parkinsonism due to drugs (eg, antipsychotics) or disease (such as progressive supranuclear palsy, essential tremor, multiple system atrophy [eg, striatonigral degeneration, olivopontocerebellar atrophy], or postencephalitic parkinsonism)
Have a current implantable intracranial stimulator or history of intracranial ablation surgery (eg, subthalamic, globus pallidus-internal segment)
Have a current or any previous diagnosis of bipolar disorder, schizophrenia, or other primary psychotic disorder
Have poorly controlled psychosis (hallucinations or delusions) that in the opinion of the investigator would interfere with the subject's ability to be compliant with the study protocol
Have any other psychiatric disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol
Have a serious or unstable medical illness, other than idiopathic PD, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality as determined by the investigator.
Subjects with acute liver disease
Have used antipsychotic medications, with the exception of clozapine, quetiapine, pimavanserin in the 6 months prior to screening (Visit 1) and at any time during the course of the study
Have used trihexphenidyl and benztropien in the 4 weeks prior to screening (Visit 1) and at any time during the course of the study
Have a motor conditions for which the antiparkinsonian teratment is expected to change during the course of the study, as well as unpredictable motor fluctuations that in the investigator's opinion would interfere with conducting assessments
Are currently taking any medications or food, herbal or dietary supplements that are inhibitors (eg, ketoconazole, grapefruit juice), or strong/moderate inducers of cytochrome P450 3A4 (CP3A4) (eg, rifampicin)
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 3 months, in a clinical study involving an interventional product or device
Have previously been exposed to LY3154207
Updated on
19 Feb 2024.
Study ID: 1709267154
This study investigates how an investigational medication compares with a placebo in treating memory and thinking problems in individuals with mild-to-moderate Parkinson's disease dementia. Parkinson's disease dementia (PDD) is a condition where people with Parkinson's disease experience a decline in cognitive functions, such as memory and thinking abilities, affecting their daily activities.
Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will involve taking the medication daily for 12 weeks to observe any changes in cognitive function.
- Who can participate: Adults with idiopathic Parkinson's disease for at least 2 years and experiencing dementia can participate. They must be on a stable dosage of medications affecting cognition and have a reliable caregiver for visits.
- Study details: Participants will take either the investigational medication or a placebo daily for 12 weeks. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants must follow study rules, including not sharing personal medical data online.
- Study Timelines and Visits: The study will last 12 weeks. The study requires 6 visits.
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