Circulating Ghrelin as a Biomarker for Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Ghrelin ratio in PD and PDD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •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
- •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
研究组 & 干预措施
Healthy control
Venous blood collection
干预措施: Venous blood collection (Diagnostic Test)
Parkinson's disease
Venous blood collection
干预措施: Venous blood collection (Diagnostic Test)
Parkinson's disease dementia
Venous blood collection
干预措施: Venous blood collection (Diagnostic Test)
Dementia with Lewy Bodies
Venous blood collection
干预措施: Venous blood collection (Diagnostic Test)
Alzheimer's disease
Venous blood collection
干预措施: Venous blood collection (Diagnostic Test)
结局指标
主要结局
Ghrelin ratio in PD and PDD
时间窗: Through study completion, an average of 1 year
Quantification of circulating ghrelin peptides
次要结局
- Ghrelin ratio in AD and DLB(Through study completion, an average of 1 year)
- Immune cell function in PD, PDD, DLB and AD.(Through the study, an average of 1 year.)
- LEAP2 levels in PD, PDD, DLB and AD(Through study completion, an average of 1 year.)
- Insulin in control, PD, PDD, DLB and AD.(Through study completion, an average of 1 year.)
- Proteomics of control, PD, PDD, AD and DLB donor samples.(Through the study, an average of 1 year.)