Dementia
Conditions
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.
Interventions
DIAGNOSTIC_TESTVenous blood collection
Participants will undergo venous blood collection following an overnight fast and 5, 60 and 180 minutes following food intake.
Sponsors
Swansea University
Newcastle University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ghrelin ratio in PD and PDD | Through study completion, an average of 1 year | Quantification of circulating ghrelin peptides |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ghrelin ratio in AD and DLB | Through study completion, an average of 1 year | Quantification of circulating ghrelin peptides |
| Immune cell function in PD, PDD, DLB and AD. | 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. |
| LEAP2 levels in PD, PDD, DLB and AD | 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. |
| Insulin in control, PD, PDD, DLB and AD. | 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. |
| Proteomics of control, PD, PDD, AD and DLB donor samples. | Through the study, an average of 1 year. | Quantification of proteins via Next Generation Sequencing (NGS)-based proteomics. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORJeffrey S Davies, BSc, PhD
Swansea University
Outcome results
None listed