Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570109
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Frailty and Functional Ability in Alzheimers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Association Between Decline in Functional Ability and Frailty in Community-dwelling Older Adults Living With Alzheimers Dementia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of this study is to investigate the association between frailty as defined by the Fried Frailty Phenotype and risk of functional decline in patients with Alzheimers dementia The hypothesis is that frailty is associated with greater functional decline in community-dwelling older people with Alzheimers dementia compared to those without frailty
Secondary aims include investigation of long-term risk of institutionalization through administrative follow-up and trajectories of assessment components in future assessment
The study is designed as a prospective cohort study Participants in the study will undergo an assessment battery at baseline 1 years of follow-up and administrative follow-up for 5 years
Participants will be recruited from patients of the Unit of Dementia at Aalborg University Hospital within 3 months of dementia diagnosis The time frame of 3 months after diagnosis was chosen to ensure that cognitive assessment in the Unit of Dementia was reflective of patients cognitive level and thereby ability to consent at inclusion Patients will be eligible for inclusion if they are 65 years or older have a diagnosis of mild or moderate Alzheimers or mixed Alzheimers and vascular dementia live at home and are able to walk 5 meters independently of other people walking aids will be allowed The severity of dementia will be defined according to score on the Mini Mental State Examination MMSE as it has done in other studies According to this definition a MMSE score between 20-30 indicates mild Alzheimers dementia and a MMSE score from 15-19 indicates moderate dementia People with moderately severe and severe Alzheimers dementia defined as MMSE score below 15 will not be eligible to participate
Secondary aims include investigation of long-term risk of institutionalization through administrative follow-up and trajectories of assessment components in future assessment
The study is designed as a prospective cohort study Participants in the study will undergo an assessment battery at baseline 1 years of follow-up and administrative follow-up for 5 years
Participants will be recruited from patients of the Unit of Dementia at Aalborg University Hospital within 3 months of dementia diagnosis The time frame of 3 months after diagnosis was chosen to ensure that cognitive assessment in the Unit of Dementia was reflective of patients cognitive level and thereby ability to consent at inclusion Patients will be eligible for inclusion if they are 65 years or older have a diagnosis of mild or moderate Alzheimers or mixed Alzheimers and vascular dementia live at home and are able to walk 5 meters independently of other people walking aids will be allowed The severity of dementia will be defined according to score on the Mini Mental State Examination MMSE as it has done in other studies According to this definition a MMSE score between 20-30 indicates mild Alzheimers dementia and a MMSE score from 15-19 indicates moderate dementia People with moderately severe and severe Alzheimers dementia defined as MMSE score below 15 will not be eligible to participate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None