Frailty Outcomes And Risk With Alzheimer's Related Dementia (FORWARD)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: Frailty

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 900
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Frail; Defined by Fried Frailty Criteria	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
Non-Frail/pre-frail; Defined by Fried Frailty Criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nursing home admission	Admission to nursing home (time to event)	5 years
Mortality	Death (time to event)	5 years

Collaborators and Investigators

• Sponsor: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: N-20230068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No