NCT05381090

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

May 20, 2021

Last Update Submit

October 25, 2023

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • Ghrelin ratio in PD and PDD

    Quantification of circulating ghrelin peptides

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Ghrelin ratio in AD and DLB

    Through study completion, an average of 1 year

Study Arms (5)

Healthy control

ACTIVE COMPARATOR

Venous blood collection

Diagnostic Test: Venous blood collection

Parkinson's disease

EXPERIMENTAL

Venous blood collection

Diagnostic Test: Venous blood collection

Parkinson's disease dementia

EXPERIMENTAL

Venous blood collection

Diagnostic Test: Venous blood collection

Dementia with Lewy Bodies

EXPERIMENTAL

Venous blood collection

Diagnostic Test: Venous blood collection

Alzheimer's disease

EXPERIMENTAL

Venous blood collection

Diagnostic Test: Venous blood collection

Interventions

Venous blood collectionDIAGNOSTIC_TEST

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

Alzheimer's diseaseDementia with Lewy BodiesHealthy controlParkinson's diseaseParkinson's disease dementia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • Evidence of dementia or mild cognitive impairment
  • Deep brain stimulation (DBS)
  • Use of Duodopa
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, sa2 8pp, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jeffrey S Davies, BSc, PhD

    Swansea University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola A Griffiths

CONTACT

0179260resgov@swansea.ac.uk

Kathie Wareham

CONTACT

kathie.wareham@wales.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 19, 2022

Study Start

August 15, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)