Control of periodontal inflammation, systemic inflammatory responses and cognitive decline in Alzheimer?'s disease

Not Applicable

Completed

• Conditions: Periodontitis and disease progression in Alzheimer?'s disease; Nervous System Diseases; Alzheimer disease

• Registration Number: ISRCTN34471493
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-16
• Study Completion: 2016-09-22
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adults aged 70 years or older, either sex
2. Amnestic according to Consortium to Establish a Registry for Alzheimer's Disease (CERAD) cognitive battery norms
3. Mini?Mental State Examination (MMSE) score range between 24-30
4. Geriatric Depression Scale less than/equals 4/5
5. Clinical Dementia rating scale score of less than/equals 0.5
6. Participants should be nonsmoking, in good general health and English speaking in order to allow valid cognitive assessment to take place
7. Willing and able to participate in study

Exclusion Criteria

1. Less than 70 years old
2. Recent change in relevant medication
3. Current or recent smoker.
4. With 8 teeth or less
5. Not deemed sufficiently fit to undergo operative dental treatment including extractions
6. Recent active periodontal treatment
7. Reporting a history of local oropharyngeal radiotherapy resulting in oral dryness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasiblity and effectiveness of periodontal treatment at improving oral health in people with mild cognitive impairment (primary outcome A: changes in plaque scores, probing depths and bleeding scores), measured at 6-7 weeks

Secondary Outcome Measures

Name	Time	Method
1. Levels of circulating proinflammatory cytokines (CRP and IL-6) <br>2. Rate of cognitive decline (change in CERAD score in 6 weeks; secondary outcome B change in rate of conversion to dementia over 1 year)<br>3. Whether there is a shared complex inflammatory marker for periodontitis and mild cognitive impairment and whether change in this marker set predicts response to therapy (shared marker set, predictive value of marker set)<br><br>Measured at 6 months and final assessment at one year.