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Circulating Ghrelin as a Biomarker for Dementia (GDEM3)

Primary Purpose

Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Venous blood collection
Sponsored by
Swansea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 60 years
  • 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:

  • Age < 60 years
  • 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;

  • Parkinson's Disease exclusion criteria
  • Evidence of dementia or mild cognitive impairment
  • Deep brain stimulation (DBS)
  • Use of Duodopa

Parkinson's Disease Dementia exclusion criteria

  • Dementia within 12 months of diagnosis of PD
  • DBS

Dementia with Lewy bodies exclusion criteria

  • Onset of motor Parkinsonism symptoms greater than 12 months prior to dementia diagnosis

Alzheimer's dementia exclusion criteria

  • Presence of PD, PDD, DLB, or Frontotemporal Dementia (FTD)

Controls exclusion criteria

  • Evidence of parkinsonism
  • Evidence of dementia or mild cognitive impairment
  • MoCA <26/30

Sites / Locations

  • Swansea UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy control

Parkinson's disease

Parkinson's disease dementia

Dementia with Lewy Bodies

Alzheimer's disease

Arm Description

Venous blood collection

Venous blood collection

Venous blood collection

Venous blood collection

Venous blood collection

Outcomes

Primary Outcome Measures

Ghrelin ratio in PD and PDD
Quantification of circulating ghrelin peptides

Secondary Outcome Measures

Ghrelin ratio in AD and DLB
Quantification of circulating ghrelin peptides

Full Information

First Posted
May 20, 2021
Last Updated
September 8, 2022
Sponsor
Swansea University
Collaborators
Newcastle University
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1. Study Identification

Unique Protocol Identification Number
NCT05381090
Brief Title
Circulating Ghrelin as a Biomarker for Dementia
Acronym
GDEM3
Official Title
Circulating Ghrelin as a Biomarker for Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swansea University
Collaborators
Newcastle University

4. Oversight

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

5. Study Description

Brief Summary
The primary objective of this study will explore whether circulating acyl-ghrelin (AG) and unacylated-ghrelin (UAG) are reduced in neurodegenerative disease associated with cognitive impairment. It will focus on validating pilot data generated following the analysis of Parkinson's disease (PD), Parkinson's disease dementia (PDD) and healthy cohorts (IRAS project ID: 250933). In addition to the advantages of study replication we will extend the analysis to include two further patient groups that are associated with cognitive impairments, namely, Alzheimer's dementia (AD) and dementia with Lewy bodies (DLB). This study will increase confidence in the replication of our findings. This will be a cross-sectional study using peripheral venous blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy control
Arm Type
Active Comparator
Arm Description
Venous blood collection
Arm Title
Parkinson's disease
Arm Type
Experimental
Arm Description
Venous blood collection
Arm Title
Parkinson's disease dementia
Arm Type
Experimental
Arm Description
Venous blood collection
Arm Title
Dementia with Lewy Bodies
Arm Type
Experimental
Arm Description
Venous blood collection
Arm Title
Alzheimer's disease
Arm Type
Experimental
Arm Description
Venous blood collection
Intervention Type
Diagnostic Test
Intervention Name(s)
Venous blood collection
Intervention Description
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Primary Outcome Measure Information:
Title
Ghrelin ratio in PD and PDD
Description
Quantification of circulating ghrelin peptides
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Ghrelin ratio in AD and DLB
Description
Quantification of circulating ghrelin peptides
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 60 years 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: Age < 60 years 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; Parkinson's Disease exclusion criteria Evidence of dementia or mild cognitive impairment Deep brain stimulation (DBS) Use of Duodopa Parkinson's Disease Dementia exclusion criteria Dementia within 12 months of diagnosis of PD DBS Dementia with Lewy bodies exclusion criteria Onset of motor Parkinsonism symptoms greater than 12 months prior to dementia diagnosis Alzheimer's dementia exclusion criteria Presence of PD, PDD, DLB, or Frontotemporal Dementia (FTD) Controls exclusion criteria Evidence of parkinsonism Evidence of dementia or mild cognitive impairment MoCA <26/30
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola A Griffiths
Phone
0179260
Ext
3849
Email
resgov@swansea.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Kathie Wareham
Email
kathie.wareham@wales.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Davies, BSc, PhD
Organizational Affiliation
Swansea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swansea University
City
Swansea
ZIP/Postal Code
sa2 8pp
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathie Wareham
Email
kathie.wareham@wales.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Circulating Ghrelin as a Biomarker for Dementia

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