Feasibility study: Can reducing periodontal infection (gum disease) slow the progression of cognitive impairment associated with Alzheimer's disease?

Not Applicable

• Conditions: Oral and dental health, Alzheimer's disease; Oral Health

• Registration Number: ISRCTN11832395
• Lead Sponsor: niversity Hospitals Bristol and Weston NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Last Update Posted: 26 August 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Diagnosis of either amnesic or multidomain mild cognitive Impairment with memory loss or early-stage Alzheimer's disease
2. Capacity to consent
3. Periodontitis (periodontal pockets of >4 mm with bleeding on probing)
4. Aged 60 years or over
5. A project partner to attend at least the first study appointment
6. A minimum of 6 teeth

Exclusion Criteria

1. Lack of one or more of the inclusion criteria
2. Uncontrolled diabetes
3. Uncontrolled dental disease that is not periodontitis
4. Scores of >=3 on the American Society of Anaesthesiologists Physical-Status-Classification-System

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility outcomes measured using patient records at the end of the study: <br>1. Recruitment rates <br>2. Compliance rates-intervention<br>3. Completion rates-data collection

Secondary Outcome Measures

Name	Time	Method
1. Periodontal scores. Periodontal assessment: Bleeding on Probing (BOP) (yes/no); periodontal pocket depths (mm)-four gingival sites/tooth; dental plaque- O’Leary plaque index (yes/no)-four surfaces/tooth at screening, 6 months, 12 months<br>2. Cognitive scores. Cognitive assessment: Clinical Dementia Rating Sum of Boxes (CDR-SB): an appropriate and widely used primary outcome measures for early and late dementia. Alzheimer’s Disease Assessment Scale Cognitive subscale (ADAS-Cog11), and Bristol Activities of Daily Living Scale (BADLS), measuring functional ability at screening, 6 months, 12 months, 18 months<br>3. Blood levels of markers that are indicative of inflammation. Blood/saliva (laboratory research): Assessed for inflammatory response and bacterial load to confirm that bacteraemia and that pathogens have been reduced by the treatment at screening, 6 months, 12 months<br>4. Qualitative data (mini interview) regarding the perceived acceptability and success of the intervention at the end of the study