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NCT06570109Enrolling by invitation

Frailty Outcomes And Risk With Alzheimer's Related Dementia

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

Source: ClinicalTrials.gov · Last updated 28 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
130 (estimated)
First submitted
22 Aug 2024
Start date
22 Aug 2024
Primary completion date
1 Sept 2027
Lead sponsor
Aalborg University Hospital
NCT number
NCT06570109

What you commit to

  • Study type: Observational
  • Planned participants: 130
  • From 22 Aug 2024 to the primary completion date, 1 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aalborg University Hospital
Coordinator of this site? Confirm its status
AalborgDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.