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Completed

NCT Number: NCT05381090

Circulating Ghrelin as a Biomarker for Dementia

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swansea University

Swansea, sa2 8pp, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous blood collection

Diagnostic Test

Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.

Primary outcomes

  1. Ghrelin ratio in PD and PDD

    Time frame: Through study completion, an average of 1 year

    Quantification of circulating ghrelin peptides

Secondary outcomes

  1. Ghrelin ratio in AD and DLB

    Time frame: Through study completion, an average of 1 year

    Quantification of circulating ghrelin peptides

  2. Immune cell function in PD, PDD, DLB and AD.

    Time frame: Through the study, an average of 1 year.

    Quantification of Peripheral Blood Mononuclear Cell (PBMC) function, via RNA-assays and protein-immunoassays from control, PD, PDD, DLB and AD donors.

  3. LEAP2 levels in PD, PDD, DLB and AD

    Time frame: Through study completion, an average of 1 year.

    Quantification of LEAP2 via immunoassay in blood plasma collected from control, PD, PDD, AD and DLB donors.

  4. Insulin in control, PD, PDD, DLB and AD.

    Time frame: Through study completion, an average of 1 year.

    Quantification of insulin via immunoassay in blood plasma collected from control, PD, PDD, DLB and AD donors.

  5. Proteomics of control, PD, PDD, AD and DLB donor samples.

    Time frame: Through the study, an average of 1 year.

    Quantification of proteins via Next Generation Sequencing (NGS)-based proteomics.

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Collaborators

  • Newcastle University

Registry information

Acronym: GDEM3

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 19, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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