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Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug (PD-MIND)

Primary Purpose

Parkinson Disease, Mild Cognitive Impairment

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AZD0328
Placebo
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Mild Cognitive Impairment, Cognition

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Active drug: AZD0328

    Placebo

    Arm Description

    Participants will receive AZD0328 capsules for oral administration.AZD0328 is a selective α7 nicotinic receptor agonist, The total daily dosage of AZD0328 is 1mg per day; administered as 0.5mg twice daily / BID. The study treatment period is 12-weeks.

    Participants will receive identical-appearing placebo capsules for oral administration.Participants will be instructed to take 2 capsules in the morning and 2 capsules in the evening for a 12-week period.

    Outcomes

    Primary Outcome Measures

    Change in Attentional Intensity Index composite factor score from baseline to week 12
    The Attentional Intensity Index composite factor score combines the speed scores from the three attention tasks (simple reaction time, choice reaction time and digit vigilance), and has been validated using factor analysis. The measure reflects the ability to focus attention and process information.

    Secondary Outcome Measures

    Change in Attentional Intensity Index composite factor score from baseline to week 6
    The Attentional Intensity Index composite factor score combines the speed scores from the three attention tasks (simple reaction time, choice reaction time and digit vigilance), and has been validated using factor analysis. The measure reflects the ability to focus attention and process information.
    Change in Sustained Attention Index composite factor score from baseline to week 6 and week 12
    The Sustained Attention Index composite factor score combines the accuracy scores from choice reaction time and digit vigilance tasks, and reflects the ability to sustain attention and ignore distraction.
    Change in Working Memory Index composite factor score from baseline to week 6 and week 12
    The Working Memory Index composite factor score combines the accuracy scores from the two working memory tasks to form this measure, which reflects the capability of holding information in working memory.
    Change in Episodic Memory Index composite factor score from baseline to week 6 and week 12
    The Episodic Memory Index composite factor score combines the verbal recall and recognition tasks with visual recognition. It reflects the longer term memory capability, like how well someone can remember a short story or what they had for dinner last night, or what they did on their last birthday.
    Change in Memory Speed Retrieval Index composite factor score from baseline to week 6 and week 12
    The Memory Speed Retrieval Index composite factor score combines the speed scores from the two working memory tasks and the picture recognition task. Factor analysis has established that the speed of retrieval from working memory and episodic memory load on a common factor, and the score reflects the time taken to successfully retrieve information held in memory.
    Change in MoCA score from screening to week 12
    The Montreal Cognitive Assessment (MoCA) assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 to 30, with lower scores indicative of greater cognitive impairment.
    Change in Sustained Attention Index composite factor score from week 12 to week 16
    The Sustained Attention Index composite factor score combines the accuracy scores from choice reaction time and digit vigilance tasks, and reflects the ability to sustain attention and ignore distraction.
    Change in Working Memory Index composite factor score from week 12 to week 16
    The Working Memory Index composite factor score combines the accuracy scores from the two working memory tasks to form this measure, which reflects the capability of holding information in working memory.
    Change in Episodic Memory Index composite factor score from week 12 to week 16
    The Episodic Memory Index composite factor score combines the verbal recall and recognition tasks with visual recognition. It reflects the longer term memory capability, like how well someone can remember a short story or what they had for dinner last night, or what they did on their last birthday.
    Change in Memory Speed Retrieval Index composite factor score from week 12 to week 16
    The Memory Speed Retrieval Index composite factor score combines the speed scores from the two working memory tasks and the picture recognition task. Factor analysis has established that the speed of retrieval from working memory and episodic memory load on a common factor, and the score reflects the time taken to successfully retrieve information held in memory.
    Change in MDS-UPDRS Part III motor examination subscale score from baseline to week 12
    Part III of the Movement Disorder Society's (MDS) Unified Parkinson's Disease Rating Scale (UPDRS), is a motor examination and objective assessment of parkinsonism. This is based on 18 items assessed by the investigator, resulting in 33 scores by location and lateralization. These 33 scores are ratings on severity: from 0 (normal) to 4 (severe).The MDS-UPDRS-III total score ranges from 0 to 132, with higher scores indicative of more severe motor and functional impairment.
    Change in total score from the Non-Motor Symptom Scale from baseline to week 12
    The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale to assess a wide array of non-motor symptoms in patients with Parkinson's disease. The NMSS measures severity (scored 0 - 3) and frequency (scored 1 - 4) of non-motor symptoms across nine dimensions. The NMSS total score ranges from 0 to 360, with higher score indicative of worse non-motor symptoms.
    Change in total score from the 39-item Parkinson's Disease Questionnaire from baseline to week 12
    The 39-item Parkinson's Disease Questionnaire (PDQ-39) is a health-related quality-of-life questionnaire. The questionnaire contains 39 self-reported items on eight domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and body discomfort. Each item is scored on 5-point Likert-type scale from 0 (never) - 4 (always), over the past month. The PDQ-39 total score is 156: the lower the score reflects a better health-related quality-of-life.
    Change in MCI-CGIC from baseline to week 12
    The MCI-adjusted Clinical Global Impression of Change (CGIC) score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behaviour, and functional abilities on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'
    Change in depression and anxiety subscale scores from the HADS from baseline to week 12
    The Hospital Anxiety and Depression Scale (HADS), has an anxiety (score 0 - 21) and a depression subscale (0 - 21), with higher subscales scores indicative of greater levels of depression / anxiety
    Incidence, nature and severity of AEs and SAEs during treatment period
    Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Incidence of dosage reduction or treatment discontinuation during treatment period
    Dosage reduction or treatment discontinuation
    Incidence of clinically significant changes or abnormal electrocardiogram (ECG) assessments, vital sign measurements and clinical laboratory values during treatment period
    Clinically significant laboratory values or vital sign measurements
    Changes in whole-brain and regionally specific brain volumes from baseline/screening to week 12
    MRI scans
    Changes in whole-brain perfusion as well as perfusion in regions of interests (ROIs) from baseline/screening to week 12
    MRI scans
    Changes in functional resting-state connectivity of the large-scale cognitive brain networks from baseline/screening to week 12
    MRI scans

    Full Information

    First Posted
    March 15, 2021
    Last Updated
    October 11, 2022
    Sponsor
    King's College London
    Collaborators
    Helse Stavanger HF, Michael J. Fox Foundation for Parkinson's Research, Parkinsons Org UK, AstraZeneca, Masaryk University, Norges Parkinsonforbund, Norway, University of Exeter, Stichting Lygature, Innovative Medicines Initiative
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04810104
    Brief Title
    Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug
    Acronym
    PD-MIND
    Official Title
    Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Delays due to COVID
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King's College London
    Collaborators
    Helse Stavanger HF, Michael J. Fox Foundation for Parkinson's Research, Parkinsons Org UK, AstraZeneca, Masaryk University, Norges Parkinsonforbund, Norway, University of Exeter, Stichting Lygature, Innovative Medicines Initiative

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 pathology of cognitive impairment in PD indicates that nicotinic agonists may be particularly relevant for this condition. This is a randomised, double-blind, placebo-controlled, parallel-group, phase 2a study of AZD0328, a selective α7 nicotinic receptor agonist, in PD-MCI. The study is an international, multi-centre study, which will take place across sites in Europe. PD-MIND will for the first time test the potential of a nicotinic agonist on cognition in PD-MCI. The primary outcome is attention, as it is a key cognitive domain in the PD-MCI profile and most likely to be affected by a α7 nicotinic agonist. Exploratory outcome measures will guide decisions on the design and conduct of future larger Phase 3 trials. Qualifying participants will be randomly assigned at baseline to either receive 0.5mg twice a day (bis in die, BID) of AZD0328 or placebo for 12 weeks. A total of 160 participants with PD-MCI will be enrolled to the study: 80 in the active (AZD0328) group and 80 in the control (placebo) group. Participants will undertake face-to-face assessments at screening, baseline, and then 3- 6- and 12- weeks after beginning study treatment (see Figure 2 for trial design overview). A subset of 90 participants will also undergo an MRI biomarker component prior to study drug administration and at study end.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Mild Cognitive Impairment
    Keywords
    Parkinson's Disease, Mild Cognitive Impairment, Cognition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a randomised, double-blind, placebo-controlled, parallel-group, phase 2a study of AZD0328, a selective α7 nicotinic receptor agonist, in PD-MCI.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active drug: AZD0328
    Arm Type
    Experimental
    Arm Description
    Participants will receive AZD0328 capsules for oral administration.AZD0328 is a selective α7 nicotinic receptor agonist, The total daily dosage of AZD0328 is 1mg per day; administered as 0.5mg twice daily / BID. The study treatment period is 12-weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive identical-appearing placebo capsules for oral administration.Participants will be instructed to take 2 capsules in the morning and 2 capsules in the evening for a 12-week period.
    Intervention Type
    Drug
    Intervention Name(s)
    AZD0328
    Intervention Description
    Active study drug
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Non-active study drug
    Primary Outcome Measure Information:
    Title
    Change in Attentional Intensity Index composite factor score from baseline to week 12
    Description
    The Attentional Intensity Index composite factor score combines the speed scores from the three attention tasks (simple reaction time, choice reaction time and digit vigilance), and has been validated using factor analysis. The measure reflects the ability to focus attention and process information.
    Time Frame
    From baseline to week 12 (end of treatment period).
    Secondary Outcome Measure Information:
    Title
    Change in Attentional Intensity Index composite factor score from baseline to week 6
    Description
    The Attentional Intensity Index composite factor score combines the speed scores from the three attention tasks (simple reaction time, choice reaction time and digit vigilance), and has been validated using factor analysis. The measure reflects the ability to focus attention and process information.
    Time Frame
    From baseline to week 6 (mid-point of treatment period)
    Title
    Change in Sustained Attention Index composite factor score from baseline to week 6 and week 12
    Description
    The Sustained Attention Index composite factor score combines the accuracy scores from choice reaction time and digit vigilance tasks, and reflects the ability to sustain attention and ignore distraction.
    Time Frame
    From baseline to week 6 (mid-point of treatment period) and week 12 (end of treatment period)
    Title
    Change in Working Memory Index composite factor score from baseline to week 6 and week 12
    Description
    The Working Memory Index composite factor score combines the accuracy scores from the two working memory tasks to form this measure, which reflects the capability of holding information in working memory.
    Time Frame
    From baseline to week 6 (mid-point of treatment period) and week 12 (end of treatment period)
    Title
    Change in Episodic Memory Index composite factor score from baseline to week 6 and week 12
    Description
    The Episodic Memory Index composite factor score combines the verbal recall and recognition tasks with visual recognition. It reflects the longer term memory capability, like how well someone can remember a short story or what they had for dinner last night, or what they did on their last birthday.
    Time Frame
    From baseline to week 6 (mid-point of treatment period) and week 12 (end of treatment period)
    Title
    Change in Memory Speed Retrieval Index composite factor score from baseline to week 6 and week 12
    Description
    The Memory Speed Retrieval Index composite factor score combines the speed scores from the two working memory tasks and the picture recognition task. Factor analysis has established that the speed of retrieval from working memory and episodic memory load on a common factor, and the score reflects the time taken to successfully retrieve information held in memory.
    Time Frame
    Fom baseline to week 6 (mid-point of treatment period) and week 12 (end of treatment period)
    Title
    Change in MoCA score from screening to week 12
    Description
    The Montreal Cognitive Assessment (MoCA) assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 to 30, with lower scores indicative of greater cognitive impairment.
    Time Frame
    From screening to week 12 (end of treatment period)
    Title
    Change in Sustained Attention Index composite factor score from week 12 to week 16
    Description
    The Sustained Attention Index composite factor score combines the accuracy scores from choice reaction time and digit vigilance tasks, and reflects the ability to sustain attention and ignore distraction.
    Time Frame
    From week 12 (end of treatment period) to week 16 (4 weeks after end of study medication dosing)
    Title
    Change in Working Memory Index composite factor score from week 12 to week 16
    Description
    The Working Memory Index composite factor score combines the accuracy scores from the two working memory tasks to form this measure, which reflects the capability of holding information in working memory.
    Time Frame
    From week 12 (end of treatment period) to week 16 (4 weeks after end of study medication dosing)
    Title
    Change in Episodic Memory Index composite factor score from week 12 to week 16
    Description
    The Episodic Memory Index composite factor score combines the verbal recall and recognition tasks with visual recognition. It reflects the longer term memory capability, like how well someone can remember a short story or what they had for dinner last night, or what they did on their last birthday.
    Time Frame
    From week 12 (end of treatment period) to week 16 (4 weeks after end of study medication dosing)
    Title
    Change in Memory Speed Retrieval Index composite factor score from week 12 to week 16
    Description
    The Memory Speed Retrieval Index composite factor score combines the speed scores from the two working memory tasks and the picture recognition task. Factor analysis has established that the speed of retrieval from working memory and episodic memory load on a common factor, and the score reflects the time taken to successfully retrieve information held in memory.
    Time Frame
    From week 12 (end of treatment period) to week 16 (4 weeks after end of study medication dosing)
    Title
    Change in MDS-UPDRS Part III motor examination subscale score from baseline to week 12
    Description
    Part III of the Movement Disorder Society's (MDS) Unified Parkinson's Disease Rating Scale (UPDRS), is a motor examination and objective assessment of parkinsonism. This is based on 18 items assessed by the investigator, resulting in 33 scores by location and lateralization. These 33 scores are ratings on severity: from 0 (normal) to 4 (severe).The MDS-UPDRS-III total score ranges from 0 to 132, with higher scores indicative of more severe motor and functional impairment.
    Time Frame
    From baseline to week 12 (end of treatment period)
    Title
    Change in total score from the Non-Motor Symptom Scale from baseline to week 12
    Description
    The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale to assess a wide array of non-motor symptoms in patients with Parkinson's disease. The NMSS measures severity (scored 0 - 3) and frequency (scored 1 - 4) of non-motor symptoms across nine dimensions. The NMSS total score ranges from 0 to 360, with higher score indicative of worse non-motor symptoms.
    Time Frame
    From baseline to week 12 (end of treatment period)
    Title
    Change in total score from the 39-item Parkinson's Disease Questionnaire from baseline to week 12
    Description
    The 39-item Parkinson's Disease Questionnaire (PDQ-39) is a health-related quality-of-life questionnaire. The questionnaire contains 39 self-reported items on eight domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and body discomfort. Each item is scored on 5-point Likert-type scale from 0 (never) - 4 (always), over the past month. The PDQ-39 total score is 156: the lower the score reflects a better health-related quality-of-life.
    Time Frame
    From baseline to week 12 (end of treatment period)
    Title
    Change in MCI-CGIC from baseline to week 12
    Description
    The MCI-adjusted Clinical Global Impression of Change (CGIC) score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behaviour, and functional abilities on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'
    Time Frame
    From baseline to week 12 (end of treatment period)
    Title
    Change in depression and anxiety subscale scores from the HADS from baseline to week 12
    Description
    The Hospital Anxiety and Depression Scale (HADS), has an anxiety (score 0 - 21) and a depression subscale (0 - 21), with higher subscales scores indicative of greater levels of depression / anxiety
    Time Frame
    From baseline to week 12 (end of treatment period)
    Title
    Incidence, nature and severity of AEs and SAEs during treatment period
    Description
    Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Time Frame
    From baseline to week 12 (end of study treatment)
    Title
    Incidence of dosage reduction or treatment discontinuation during treatment period
    Description
    Dosage reduction or treatment discontinuation
    Time Frame
    From baseline to week 12 (end of study treatment)
    Title
    Incidence of clinically significant changes or abnormal electrocardiogram (ECG) assessments, vital sign measurements and clinical laboratory values during treatment period
    Description
    Clinically significant laboratory values or vital sign measurements
    Time Frame
    From baseline to week 12 (end of study treatment)
    Title
    Changes in whole-brain and regionally specific brain volumes from baseline/screening to week 12
    Description
    MRI scans
    Time Frame
    From screening/baseline (pre-medication dosing) to week 12 (end of study treatment)
    Title
    Changes in whole-brain perfusion as well as perfusion in regions of interests (ROIs) from baseline/screening to week 12
    Description
    MRI scans
    Time Frame
    From screening/baseline (pre-medication dosing) to week 12 (end of study treatment)
    Title
    Changes in functional resting-state connectivity of the large-scale cognitive brain networks from baseline/screening to week 12
    Description
    MRI scans
    Time Frame
    From screening/baseline (pre-medication dosing) to week 12 (end of study treatment)
    Other Pre-specified Outcome Measures:
    Title
    Screening/Baseline whole-brain and regionally specific brain volumes as predictors of treatment response
    Description
    MRI scans
    Time Frame
    At screening/baseline (pre-medication dosing)
    Title
    Screening/Baseline whole-brain perfusion as well as perfusion in ROIs as predictors of treatment response
    Description
    MRI scans
    Time Frame
    At screening/baseline (pre-medication dosing)
    Title
    Screening/Baseline functional resting-state connectivity of the large-scale cognitive brain networks as predictors of treatment response
    Description
    MRI scans
    Time Frame
    At screening/baseline (pre-medication dosing)
    Title
    Placebo-controlled change in levels of exploratory blood-based biomarkers for neuroprotection and/or disease modification changes
    Description
    Blood-based biomarkers (e.g. cytokines, amyloid species, tau and alpha-synuclein)
    Time Frame
    At baseline and week 12
    Title
    Change in levels of study medication in blood from baseline to week 12
    Description
    Levels of study medication in blood
    Time Frame
    From baseline to week 12 (end of treatment period)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dag Aarsland, PhD
    Organizational Affiliation
    King's College London; Stavager Univeristy Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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