Frailty Outcomes And Risk With Alzheimer's Related Dementia

• Conditions: Alzheimer Disease

• Registration Number: NCT06570109
• Lead Sponsor: Aalborg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-22
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient IADL Change	1 year	Defined by patient reported ADL performance on the Functional Activities Questinnaire
Caregiver IADL Change	1 year	Defined by caregiver reported ADL performance on the Functional Activities Questinnaire
Caregiver BADL Change	1 year	Defined by caregiver reported ADL performance on Barthel ADL scale
Patient BADL Change	1 year	Defined by patient reported ADL performance on Barthel ADL scale

Secondary Outcome Measures

Name	Time	Method
Nursing home admission	5 years	Admission to nursing home (time to event)
Mortality	5 years	Death (time to event)

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark