Frailty Outcomes And Risk With Alzheimer's Related Dementia

NCT ID: NCT06570109

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-22
• Study Completion Date: 2027-09-01

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.

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Frail

Defined by Fried Frailty Criteria

Frailty

Intervention Type: OTHER

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

Non-Frail/pre-frail

Defined by Fried Frailty Criteria

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Johannes Riis

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

N-20230068

Identifier Type: -

Identifier Source: org_study_id