{"type":"trials","record":{"id":35128,"source_id":"clinicaltrials-gov","external_id":"NCT06570109","title":"Frailty Outcomes And Risk With Alzheimer's Related Dementia","brief_summary":"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.","overall_status":"Enrolling By Invitation","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Aalborg University Hospital","enrollment":130,"countries":["Denmark"],"start_date":"2024-08-22","completion_date":"2027-09-01","last_update_date":"2025-11-28","source_url":"https://clinicaltrials.gov/study/NCT06570109","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Enrolling By Invitation. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"FORWARD","age_range":"65 Years","comparator":null,"organization":"Aalborg University Hospital","interventions":["Frailty"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Caregiver IADL Change — 1 year","Patient IADL Change — 1 year","Caregiver BADL Change — 1 year","Patient BADL Change — 1 year","Nursing home admission — 5 years","Mortality — 5 years"],"design_description":null,"source_has_results":false},"controlled_terms":["Alzheimer Disease","Frailty"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct06570109","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-08-22 to 2027-09-01","comparator":null,"confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.479Z","intervention":["Frailty"],"participants":130,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Caregiver IADL Change — 1 year","Patient IADL Change — 1 year","Caregiver BADL Change — 1 year","Patient BADL Change — 1 year","Nursing home admission — 5 years","Mortality — 5 years"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35128","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}