Circulating Ghrelin as a Biomarker for Dementia

Launched by SWANSEA UNIVERSITY · May 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the levels of two forms of a hormone called ghrelin in people with different types of dementia, including Alzheimer's disease and dementia with Lewy bodies. Researchers want to find out if these hormone levels are lower in people with dementia compared to healthy individuals. The goal is to better understand how these hormone levels relate to cognitive impairment, which means difficulties with thinking and memory.

To participate in this study, you need to be over 60 years old and give consent, either yourself or through a representative. There are specific requirements depending on the type of dementia you may have, such as a confirmed diagnosis of Parkinson's disease or Alzheimer's disease. Participants will provide a blood sample, and the study is currently looking for individuals to join. It's important to note that there are some health conditions that would exclude you from participating, such as diabetes, current major depression, or significant weight changes. This trial aims to build on previous findings and could help improve our understanding of dementia and its biomarkers.

Gender

ALL

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