GDEM3: Circulating Ghrelin as a Biomarker for Dementia

Sponsor

Swansea University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05381090

Collaborator

Newcastle University (Other)

100

Enrollment

Location

Arms

24.6

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Diagnostic Test: Venous blood collection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Circulating Ghrelin as a Biomarker for Dementia

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy control Venous blood collection	Diagnostic Test: Venous blood collection Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Experimental: Parkinson's disease Venous blood collection	Diagnostic Test: Venous blood collection Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Experimental: Parkinson's disease dementia Venous blood collection	Diagnostic Test: Venous blood collection Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Experimental: Dementia with Lewy Bodies Venous blood collection	Diagnostic Test: Venous blood collection Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Experimental: Alzheimer's disease Venous blood collection	Diagnostic Test: Venous blood collection Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.

Outcome Measures

Primary Outcome Measures

Ghrelin ratio in PD and PDD [Through study completion, an average of 1 year]
Quantification of circulating ghrelin peptides

Secondary Outcome Measures

Ghrelin ratio in AD and DLB [Through study completion, an average of 1 year]
Quantification of circulating ghrelin peptides

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swansea University	Swansea		United Kingdom	sa2 8pp

Sponsors and Collaborators

Swansea University
Newcastle University

Investigators

Principal Investigator: Jeffrey S Davies, BSc, PhD, Swansea University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Swansea University

ClinicalTrials.gov Identifier:

NCT05381090

Other Study ID Numbers:

288862

First Posted:

May 19, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Aug 16, 2022