Frailty Outcomes And Risk With Alzheimer's Related Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Frailty.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association Between Decline in Functional Ability and Frailty in Community-dwelling Older Adults Living With Alzheimer's Dementia
Overview
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.
Interventions
- 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
Primary outcome measures
- Caregiver IADL Change [Time frame: 1 year]
- Patient IADL Change [Time frame: 1 year]
- Caregiver BADL Change [Time frame: 1 year]
- Patient BADL Change [Time frame: 1 year]
Secondary outcome measures (2)
- Nursing home admission [Time frame: 5 years]
- Mortality [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Aalborg University Hospital — Aalborg
Identifiers
NCT: NCT06570109 · N-20230068