Frailty Outcomes And Risk With Alzheimer's Related Dementia

NCT06570109 | Enrolling By Invitation

• 1 other identifier: N-20230068
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Caregiver IADL Change

  Defined by caregiver reported ADL performance on the Functional Activities Questinnaire

  1 year

• Patient IADL Change

  Defined by patient reported ADL performance on the Functional Activities Questinnaire

  1 year

• Caregiver BADL Change

  Defined by caregiver reported ADL performance on Barthel ADL scale

  1 year

• Patient BADL Change

  Defined by patient reported ADL performance on Barthel ADL scale

  1 year

Secondary Outcomes (2)

• Nursing home admission

  5 years

• Mortality

  5 years

Study Arms (2)

Frail

Defined by Fried Frailty Criteria

Other: Frailty

Non-Frail/pre-frail

Defined by Fried Frailty Criteria

Interventions

Frailty 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

Frail

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 900, Denmark

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

DK (1)