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ENROLLING BY INVITATION
NCT06570109

Frailty Outcomes And Risk With Alzheimer's Related Dementia

Sponsor: Aalborg University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2024-08-22

Completion Date

2027-09-01

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

OTHER

Frailty

defined as weigh loss (\>4.5 kg in one year), exhaustion, slow gait speed (below 20th percentile for sex and height), weakness (handgrip strength below 20th percentile for sex and BMI), and low physical activity (by the Physical Activity Scale for the Elderly). The presence of three or more out of five criteria is defined as frailty while one to two criteria is prefrailty

Locations (1)

Aalborg University Hospital

Aalborg, Denmark