Investigating Ghrelin Levels in Dementia Patients

Circulating Ghrelin as a Biomarker for Dementia

This study is testing if people with dementia have lower levels of certain hormones in their blood to see if these hormones could help identify dementia better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Swansea University (Academic / other)
• Locations: 1 site (Swansea)
• Trial ID: NCT05381090 on ClinicalTrials.gov

What this trial studies

This study aims to determine if levels of circulating acyl-ghrelin and unacylated-ghrelin are lower in patients with neurodegenerative diseases that cause cognitive impairment, such as Alzheimer's disease and dementia with Lewy bodies. It will validate previous findings from pilot data involving Parkinson's disease and Parkinson's disease dementia cohorts. The study will involve collecting peripheral venous blood samples from participants to analyze ghrelin levels. By including additional patient groups, the research seeks to strengthen the evidence regarding ghrelin as a potential biomarker for dementia.

Who should consider this trial

Good fit: Ideal candidates include individuals over 60 years old diagnosed with Parkinson's disease, Parkinson's disease dementia, Alzheimer's disease, or dementia with Lewy bodies.

Not a fit: Patients under 60 years old or those with major depression, diabetes, or significant obesity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the identification of ghrelin as a reliable biomarker for early detection and monitoring of dementia.

How similar studies have performed: Previous studies have shown promising results regarding ghrelin levels in neurodegenerative diseases, suggesting this approach has potential.

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

Where this trial is running

Swansea

• Swansea University — Swansea, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Jeffrey S Davies, BSc, PhD — Swansea University
• Study coordinator: Paola A Griffiths

Conditions Dementia