Status:
UNKNOWN
Circulating Ghrelin as a Biomarker for Dementia
Lead Sponsor:
Swansea University
Collaborating Sponsors:
Newcastle University
Conditions:
Dementia
Eligibility:
All Genders
60+ years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05381090
Start Date
August 15 2022
End Date
September 1 2024
Last Update
October 26 2023
Active Locations (1)
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1
Swansea University
Swansea, United Kingdom, sa2 8pp