Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-08-15
2024-09-30
Brief Summary
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This will be a cross-sectional study using peripheral venous blood.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Healthy control
Venous blood collection
Venous blood collection
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Parkinson's disease
Venous blood collection
Venous blood collection
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Parkinson's disease dementia
Venous blood collection
Venous blood collection
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Dementia with Lewy Bodies
Venous blood collection
Venous blood collection
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Alzheimer's disease
Venous blood collection
Venous blood collection
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Interventions
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Venous blood collection
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Eligibility Criteria
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Inclusion Criteria
* Subject or carer / legal representative is willing to sign consent document
Specific criteria for each group;
Parkinson's Disease
* PD diagnosed by a movement disorder specialist and meets the diagnosis of PD
* MoCA \> 26/30
* No evidence of cognitive symptoms causing functional impairment
Parkinson's Disease Dementia
* PD diagnosed by a movement disorder specialist
* Duration of motor symptoms \> 1 year
* Meets MDS task force criteria for PDD
* MoCA \< 21/30
Dementia with Lewy Bodies
* Meets criteria for probable DLB as defined by the 4th report of the DLB consortium
Alzheimer's Disease
* Meets criteria for probable AD dementia (consistent with NIA/AA core clinical criteria for probable AD dementia)
Exclusion Criteria
* Current major depression
* Use of anti-psychotic medication
* Type I or Type II diabetes mellitus (DM) (excluding diet-controlled DM)
* Tobacco use
* BMI \<15.0 kg/m2
* BMI \> 30 kg/m2
* Comorbid gastrointestinal disease i.e. includes Coeliac, active Inflammatory Bowel Disease (Colitis), evidence for active gastric ulcers within the last 12 months, but excludes gastroesophageal reflux and hiatus hernia.
* \>5 kg weight change over the preceding 3 months (determined by researcher from previous clinic visit and discussion with partner/carer)
* Significant active comorbidity
* Difficult venous access
* Vagotomy
Additional disease specific exclusions;
* Evidence of dementia or mild cognitive impairment
* Deep brain stimulation (DBS)
* Use of Duodopa
* Dementia within 12 months of diagnosis of PD
* DBS
* Onset of motor Parkinsonism symptoms greater than 12 months prior to dementia diagnosis
* Presence of PD, PDD, DLB, or Frontotemporal Dementia (FTD)
* Evidence of parkinsonism
* Evidence of dementia or mild cognitive impairment
* MoCA \<26/30
60 Years
ALL
Yes
Sponsors
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Newcastle University
OTHER
Swansea University
OTHER
Responsible Party
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Principal Investigators
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Jeffrey S Davies, BSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Swansea University
Locations
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Swansea University
Swansea, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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288862
Identifier Type: -
Identifier Source: org_study_id
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