Clinical trial NCT06570109: Frailty and Functional Ability in Alzheimers
Official title: Association Between Decline in Functional Ability and Frailty in Community-dwelling Older Adults Living With Alzheimer's Dementia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to include community-dwelling people living at home with mild to moderate Alzheimers dementia aged 65+. Participant will be included only within 3 months of dementia diagnosis. Consecutive sampling at the Unit of Dementia in Northen Jutland in Denmark will be employed.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Caregiver IADL Decline
timeFrame: 1 year
measure: Patient IADL Decline
timeFrame: 1 year
measure: Caregiver BADL Decline
timeFrame: 1 year
measure: Patient BADL Decline
timeFrame: 1 year
Secondary outcomes:
measure: Nursing home admission
timeFrame: 5 years
measure: Mortality
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: