Image

Circulating Ghrelin as a Biomarker for Dementia

Recruiting
60 years of age
Both
Phase N/A

Powered by AI

Overview

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

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

Study details

Dementia

NCT05381090

Swansea University

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.