Clinical trial NCT05381090: Circulating Ghrelin as a Biomarker for Dementia
Official title: Circulating Ghrelin as a Biomarker for Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: Newcastle University
First posted: 2022-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Ghrelin ratio in PD and PDD
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Ghrelin ratio in AD and DLB
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
Study officials:
affiliation: Swansea University
name: Jeffrey S Davies, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: