Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College London
• Collaborators: AstraZeneca; Helse Stavanger HF; Innovative Medicines Initiative; Masaryk University; Michael J. Fox Foundation for Parkinson's Research; Norges Parkinsonforbund, Norway; Parkinsons Org UK; Stichting Lygature; University of Exeter

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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