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

A

Aalborg University Hospital

Status

Invitation-only

Conditions

Alzheimer Disease

Treatments

Other: Frailty

Study type

Observational

Funder types

Other

Identifiers

NCT06570109
N-20230068

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

130 participants in 2 patient groups

Frail
Description:
Defined by Fried Frailty Criteria
Treatment:
Other: Frailty
Non-Frail/pre-frail
Description:
Defined by Fried Frailty Criteria

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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