Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03755362
Status:
TERMINATED
Last Update Posted:
2021-07-23
First Post:
2018-11-12
Brief Title:
Dental Carotid Cognitive Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Treatment of Periodontitis to Prevent Dementia in Older Adults With Asymptomatic Carotid Artery Stenosis and Mild Cognitive Impairment
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The COVID-19 pandemic has disrupted our ability to continue this study Follow-up visits were missed to the COVID-19 pandemic restrictions We have elected to close enrollment and stop follow-up visits
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Periodontal Disease PD is present in 60 of adults 65 years and is associated with tobacco smoking diabetes and atherosclerosis that worsen inflammation comorbidities common in older people with mild to moderate cognitive impairment MCI Older MCI patients are prone to poor oral hygiene and dental health which if untreated worsens inflammation-mediated brain and nervous system function and accelerates progression to dementia Asymptomatic carotid artery stenosis ACAS is often a silent disease detected in only 10 of older adults and may have a strong association with MCI This study examines the effects of intensive therapy for periodontitis on cognition in high-risk older people with ACAS Results could highlight PD as a readily modifiable risk factor for dementia
Detailed Description:
Periodontal Disease PD is present in 60 of adults 65 years and is associated with tobacco smoking diabetes and atherosclerosis that worsen inflammation comorbidities common in older people with mild to moderate cognitive impairment MCI Older MCI patients are prone to poor oral hygiene and dental health which if untreated worsens inflammation-mediated brain and nervous system function and accelerates progression to dementia Asymptomatic carotid artery stenosis ACAS is often a silent disease detected in only 10 of older adults and may have a strong association with MCI This study examines the effects of intensive therapy for periodontitis on cognition in high-risk older people with ACAS Results could highlight PD as a readily modifiable risk factor for dementia
This pilot study examines the hypothesis that intensive treatment of PD IPT in older people with MCI and ACAS will attenuate their cognitive decline by reducing oral microbial-mediated inflammation and improving cerebrovascular endothelial function that contribute to neurodegeneration-associated dementia
The aims are to determine the effects of intensive compared to control PD treatment randomized IPT vs CPT in 60 MCI subjects with ACAS and PD on 1 Cognitive function Primary Outcome and quality of life Secondary Outcome and 2 The potential mechanisms mediating these effects
This pilot study examines the hypothesis that intensive treatment of PD IPT in older people with MCI and ACAS will attenuate their cognitive decline by reducing oral microbial-mediated inflammation and improving cerebrovascular endothelial function that contribute to neurodegeneration-associated dementia
The aims are to determine the effects of intensive compared to control PD treatment randomized IPT vs CPT in 60 MCI subjects with ACAS and PD on 1 Cognitive function Primary Outcome and quality of life Secondary Outcome and 2 The potential mechanisms mediating these effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None