Status:
WITHDRAWN
Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug
Lead Sponsor:
King's College London
Collaborating Sponsors:
Helse Stavanger HF
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
To test for the first time the potential of a nicotinic agonist on cognitive symptoms in people with mild cognitive impairment (MCI) in Parkinson's disease (PD), referred to as PD-MCI.
Detailed Description
There is an unmet clinical need to treat PD-MCI. As outlined previously, PD-MCI is common, has important clinical consequences, and there is currently no available treatment. Moreover, the underlying ...
Eligibility Criteria
Inclusion
- Aged between 50 to 80 years (inclusive) at time of consent
- Duration of motor symptoms of at least 1 year
- Hoehn and Yahr stage between 1 and 3 (inclusive) in ON state
- Diagnosis of PD according to United Kingdom (UK) Brain Bank criteria
- Score on Clinical Dementia Rating (CDR) scale = 0.5
- Diagnosis of PD-MCI according to MDS PD-MCI, Level I criteria
- Duration of cognitive impairment of at least 3 months (to distinguish from mild delirium)
Exclusion
- Insufficient fluency in English or local language to complete assessments
- Severe visual or auditory impairment that may interfere with participant's ability to complete assessments
- Unable to provide informed consent at screening visit
- Participation in a clinical study involving an investigational drug within 4 months prior to screening
- Smoking (cigarettes, pipes, cigars, e-cigarettes etc.) or use of smokeless tobacco products (chewing / dipping tobacco, snuff etc.) or anti-smoking nicotine containing products (patches/gum/sprays etc.), within the last 12 weeks
- HADS depression subscale score ≥ 11
- History of deep brain stimulation or other neurosurgical procedure
- Diagnosis of dementia, including Parkinson's disease dementia (PDD) or Dementia with Lewy Bodies (DLB).
- Diagnosis of schizophrenia, bipolar disorder or other psychotic disorder
- Malignant neoplasms within 3 years of screening (except for basal or squamous cell carcinoma of the skin); or had curative surgery/treatment and has been free of malignancy for at least 12 months)
- Any medical condition that in the opinion of the investigator may be contributing to cognitive impairment, above and beyond that caused by the participant's PD,
- Current evidence of any other medical condition not stably or adequately controlled, and which in the opinion of the investigator may affect participant safety or study participation
- Using any prohibited medications or permitted medications that do not meet stable dosing regimen requirements, as specified in section 5.7
- Clinically significant vital sign or ECG measure at screening or baseline visit, that in the opinion of the investigator would prevent participant from safely participating in this study
- Clinically significant clinical laboratory result from screening visit, that in the opinion of the investigator would prevent participant from safely participating in this study
- Significant renal function impairment as indicated by estimated glomerular filtration rate (eGFR) \< 45ml/min); Note: The eGFR is calculated using a formula derived from the Modification of Diet in Renal Disease Study (MDRD formula): eGFR= \[186.3 x (Creatinine/88.4)-1.154 x (Age)-0.203\] x \[0.742 if female\] x \[1.210 if black\]
- Unable to complete computerised cognitive test battery
- Marked cerebrovascular disease from MRI or CT scan within last 12 months (defined as Fazekas scale ≥ grade 3)
- Females who are breast-feeding
- Female participants assessed as being of child-bearing potential that have a positive pregnancy test at screening or baseline
- The participant does not understand or agree to comply with the contraception or reproductive requirements of the study
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04810104
Start Date
October 1 2022
End Date
April 1 2024
Last Update
October 14 2022
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