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Enrolling by Invitation

NCT Number: NCT06570109

Frailty Outcomes And Risk With Alzheimer's Related 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.

Enrolling by Invitation

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, 900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Caregiver IADL Change

    Time frame: 1 year

    Defined by caregiver reported ADL performance on the Functional Activities Questinnaire

  2. Patient IADL Change

    Time frame: 1 year

    Defined by patient reported ADL performance on the Functional Activities Questinnaire

  3. Caregiver BADL Change

    Time frame: 1 year

    Defined by caregiver reported ADL performance on Barthel ADL scale

  4. Patient BADL Change

    Time frame: 1 year

    Defined by patient reported ADL performance on Barthel ADL scale

Secondary outcomes

  1. Nursing home admission

    Time frame: 5 years

    Admission to nursing home (time to event)

  2. Mortality

    Time frame: 5 years

    Death (time to event)

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Acronym: FORWARD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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