DementiaGDEM3NCT05381090
Circulating Ghrelin as a Biomarker for Dementia
A study testing Venous blood collection in people with Dementia, run by Swansea University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Venous blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dementia
- Being tested
- Venous blood collection
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood collectionDiagnostic test
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Active comparator | Venous blood collection Receives: Diagnostic Test: Venous blood collection |
| Parkinson's disease | Experimental | Venous blood collection Receives: Diagnostic Test: Venous blood collection |
| Parkinson's disease dementia | Experimental | Venous blood collection Receives: Diagnostic Test: Venous blood collection |
| Dementia with Lewy Bodies | Experimental | Venous blood collection Receives: Diagnostic Test: Venous blood collection |
| Alzheimer's disease | Experimental | Venous blood collection Receives: Diagnostic Test: Venous blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin ratio in PD and PDD
Quantification of circulating ghrelin peptides
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Ghrelin ratio in AD and DLB
Quantification of circulating ghrelin peptides
Measured: Through study completion, an average of 1 year
Immune cell function in PD, PDD, DLB and AD.
Quantification of Peripheral Blood Mononuclear Cell (PBMC) function, via RNA-assays and protein-immunoassays from control, PD, PDD, DLB and AD donors.
Measured: Through the study, an average of 1 year.
LEAP2 levels in PD, PDD, DLB and AD
Quantification of LEAP2 via immunoassay in blood plasma collected from control, PD, PDD, AD and DLB donors.
Measured: Through study completion, an average of 1 year.
Insulin in control, PD, PDD, DLB and AD.
Quantification of insulin via immunoassay in blood plasma collected from control, PD, PDD, DLB and AD donors.
Measured: Through study completion, an average of 1 year.
Proteomics of control, PD, PDD, AD and DLB donor samples.
Quantification of proteins via Next Generation Sequencing (NGS)-based proteomics.
Measured: Through the study, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start15 Aug 2022
- Primary completion6 Feb 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Davies, BSc, PhD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381090
- Sponsor's protocol ID
- 288862
- Acronym
- GDEM3
- Status last verified
- Jun 2026
- First submitted
- 20 May 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Ghrelin as a Biomarker for Dementia
- ClinicalTrials.gov ID
- NCT05381090
- Acronym / sponsor ID
- GDEM3 / 288862
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy control | Active comparator | Diagnostic Test: Venous blood collectionVenous blood collection |
| Parkinson's disease | Experimental | Diagnostic Test: Venous blood collectionVenous blood collection |
| Parkinson's disease dementia | Experimental | Diagnostic Test: Venous blood collectionVenous blood collection |
| Dementia with Lewy Bodies | Experimental | Diagnostic Test: Venous blood collectionVenous blood collection |
| Alzheimer's disease | Experimental | Diagnostic Test: Venous blood collectionVenous blood collection |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood collectionParticipants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake. | Diagnostic test | Alzheimer's disease, Dementia with Lewy Bodies, Healthy control, Parkinson's disease, Parkinson's disease dementia |
Primary outcome
Ghrelin ratio in PD and PDD
Time frame: Through study completion, an average of 1 year
Quantification of circulating ghrelin peptides
5 secondary outcomes
Ghrelin ratio in AD and DLB
Time frame: Through study completion, an average of 1 year
Immune cell function in PD, PDD, DLB and AD.
Time frame: Through the study, an average of 1 year.
LEAP2 levels in PD, PDD, DLB and AD
Time frame: Through study completion, an average of 1 year.
Insulin in control, PD, PDD, DLB and AD.
Time frame: Through study completion, an average of 1 year.
Proteomics of control, PD, PDD, AD and DLB donor samples.
Time frame: Through the study, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S Davies, BSc, PhD principal investigator
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous blood collection in people with Dementia, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ghrelin ratio in PD and PDD (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.