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Clinical Trials/NCT06570109
NCT06570109Enrolling By InvitationNot Applicable

Association Between Decline in Functional Ability and Frailty in Community-dwelling Older Adults Living With Alzheimer's Dementia

Aalborg University Hospital1 site in 1 country130 target enrollmentStarted: August 22, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
130
Locations
1
Primary Endpoint
Patient IADL Change

Study Overview

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 Alzheimer's dementia. The hypothesis is that frailty is associated with greater functional decline in community-dwelling older people with Alzheimer's 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 patient's 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 Alzheimer's or mixed (Alzheimer's 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 Alzheimer's dementia and a MMSE score from 15-19 indicates moderate dementia. People with moderately severe and severe Alzheimer's dementia defined as MMSE score below 15 will not be eligible to participate.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of Alzheimers Dementia
  • MMSE > 14
  • Age >= 65
  • Not living in institution
  • Able to walk 5m without assistence (walking aids accepted)

Exclusion Criteria

  • No available caregiver/proxy
  • Unable to give informed consent as judged by caregiver/proxy or researcher
  • Time from diagnosis > 3 months

Outcomes

Primary Outcomes

Patient IADL Change

Time Frame: 1 year

Defined by patient reported ADL performance on the Functional Activities Questinnaire

Caregiver IADL Change

Time Frame: 1 year

Defined by caregiver reported ADL performance on the Functional Activities Questinnaire

Caregiver BADL Change

Time Frame: 1 year

Defined by caregiver reported ADL performance on Barthel ADL scale

Patient BADL Change

Time Frame: 1 year

Defined by patient reported ADL performance on Barthel ADL scale

Secondary Outcomes

  • Nursing home admission(5 years)
  • Mortality(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Johannes Riis

MD

Aalborg University Hospital

Study Sites (1)

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