Circulating Ghrelin as a Biomarker for Dementia
- Conditions
- Dementia
- Interventions
- Diagnostic Test: Venous blood collection
- Registration Number
- NCT05381090
- Lead Sponsor
- Swansea University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dementia with Lewy Bodies Venous blood collection Venous blood collection Healthy control Venous blood collection Venous blood collection Parkinson's disease Venous blood collection Venous blood collection Alzheimer's disease Venous blood collection Venous blood collection Parkinson's disease dementia Venous blood collection Venous blood collection
- Primary Outcome Measures
Name Time Method Ghrelin ratio in PD and PDD Through study completion, an average of 1 year Quantification of circulating ghrelin peptides
- Secondary Outcome Measures
Name Time Method Ghrelin ratio in AD and DLB Through study completion, an average of 1 year Quantification of circulating ghrelin peptides
Trial Locations
- Locations (1)
Swansea University
🇬🇧Swansea, United Kingdom