Feasibility study: To assess whether reducing periodontal infection (gum disease) slows the progression of cognitive impairment associated with Alzheimer’s disease.
Award Number
NIHR203048Programme
Research for Patient BenefitStatus / Stage
CompletedDates
2 July 2022 -1 July 2025
Duration (calculated)
02 years 11 monthsFunder(s)
NIHRFunding Amount
£261,791.00Funder/Grant study page
NIHRContracted Centre
University Hospitals Bristol and Weston NHS Foundation TrustContracted Centre Webpage
Principal Investigator
Professor Nicola WestPI Contact
N.X.West@bristol.ac.ukPI ORCID
0000-0002-9127-5530WHO Catergories
Development of novel therapiesTools and methodologies for interventions
Understanding risk factors
Understanding Underlying Disease
Disease Type
Alzheimer's Disease (AD)CPEC Review Info
| Reference ID | 213 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Award Number | NIHR203048 |
|---|---|
| Status / Stage | Completed |
| Start Date | 20220702 |
| End Date | 20250701 |
| Duration (calculated) | 02 years 11 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | University Hospitals Bristol and Weston NHS Foundation Trust |
| Contracted Centre Webpage | |
| Funding Amount | £261,791.00 |
Abstract
Can intensive treatment of gum disease, personalised oral hygiene instruction delivered using motivational techniques combined with professional mechanical treatment, improve and maintain oral health, slow the rate of cognitive decline in Alzheimer s patients? Background: Alzheimer s disease(AD), accounts for ~65% of dementia cases, affecting over 500,000 people in the UK. Serious social and financial consequences arise from this, with an estimated cost to the economy of ~£23bn/year[1-2]. AD brain pathology of misfolded amyloid and tau proteins, neuroinflammation and neuronal death[3] slowly progresses through brain areas important for functions such as memory and decision-making[4]. Current drugs ameliorate symptoms but don t slow progression[5], and although a newly licensed drug, Aducanumab, may slow toxic amyloid build-up in some patients, this costs $50,000/person/year[6]. Evidence now suggests that amyloid-induced neuroinflammation may arise from the brain s response to bacteria[7], particularly oral[8] likely from gum disease(periodontitis). Furthermore, type-2 diabetes and rheumatoid-arthritis, inflammatory diseases associated with periodontitis[9], can be improved by oral hygiene treatment[10-11]. Aims and Objectives: Overarching Aim: To determine if improved periodontal health can slow AD progression. Aim of the feasibility trial Assess the feasibility of conducting a randomised controlled trial of an Intensive Dental Care intervention, compared with the Standard Dental Care provided in General Dental Practice, in AD-patients to slow-down decline in cognitive function. Objectives: show recruitment rates, retention rates and data completion rates improvement in oral health in the intervention arm patients at 12-months measures of cognitive decline show sensitivity to change over 12-months blood levels of inflammatory markers show sensitivity to changes in periodontal disease status over 12-months Methods AD patients with periodontitis will be randomised to either Standard(n=25) or Intensive(n=25) dental care. Intensive dental care(IDC) comprises treatment for periodontitis, and oral hygiene instruction tailored for the individual, delivered using motivational techniques. Standard dental care(SDC) is the standard of dental care provided by the general dental services. Gum health and cognitive assessments at baseline, 6- and 12-months will be supplemented by measuring inflammatory biomarkers in saliva and blood. An 18-month cognitive assessment of participants completing 12-months sufficiently early will also undertaken. Participant and dentist acceptability of the intervention/study design will be determined by semi-structured interview. Timelines for delivery: Three-year feasibility trial with 12-month recruitment and 12/18-month follow-up. Anticipated Impact and Dissemination: Successful recruitment and demonstration of improved and maintained oral health following IDC will support an application for a larger study to determine its ability to slow cognitive decline. If proven successful this intervention could be provided by General Dental Practitioners(GDPs) with minimal top-up training, providing great impact; slowing symptom progression for 1-5 years, saving more than the cost of intervention. Data will be disseminated internationally and through routes identified by the Patient Advisory Group(PAG). The Chief Investigator is Secretary-General of the European Federation of Periodontology and an adviser to the General Dental Council and NHS-England, ensuring study findings are disseminated via these routes to carers and healthcare professionals, and will exert pressure for the implementation of GDP top-up training to enable AD-patients to access this treatment.
Aims
To determine if improved periodontal health can slow AD progression. Aim of the feasibility trial Assess the feasibility of conducting a randomised controlled trial of an Intensive Dental Care intervention, compared with the Standard Dental Care provided in General Dental Practice, in AD-patients to slow-down decline in cognitive function. Objectives: show recruitment rates, retention rates and data completion rates improvement in oral health in the intervention arm patients at 12-months measures of cognitive decline show sensitivity to change over 12-months blood levels of inflammatory markers show sensitivity to changes in periodontal disease status over 12-months