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Recruiting NCT07629349

Dementia With Lewy Bodies: Clinical Symptoms, Biomarkers and Progression

Observational Dementia With Lewy Bodies (DLB) Mild Cognitive Impairment (MCI) Cognitively Unimpaired Other Dementias

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dementia With Lewy Bodies (DLB), Mild Cognitive Impairment (MCI), Cognitively Unimpaired, Other Dementias. Basic parameters: No limits · 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
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this observational study is to improve the detection of dementia with Lewy bodies (DLB) and its prodromal phases, as well as advancing our current understanding of biological mechanisms and therapeutic options. The data is acquired at cognitive clinics in Stockholm (Sweden) and combined with national and international data to increase statistical power, representativeness and replication of results. Participants undergo collection of clinical assessments, neuroimaging and fluid biomarkers.

Detailed description

The cohort from cognitive clinics in Stockholm (Sweden) constitutes the Find-DLB cohort, and comprises patients included retrospectively up to 2020 and prospectively from 2020 onward.

Primary outcome measures

  • Cerebrospinal fluid amyloid-beta 1-42 [Time frame: Data for this outcome are collected at baseline.]
  • Cerebrospinal fluid phosphorylated tau 181 [Time frame: Data for this outcome are collected at baseline.]
  • DaT-Scan [Time frame: Data for this outcome are collected at baseline.]
  • MRI [Time frame: Data for this outcome are collected at baseline.]
  • EEG [Time frame: Data for this outcome are collected at baseline.]
  • FDG-PET [Time frame: Data for this outcome are collected at baseline.]
  • RAVLT [Time frame: Within 6 months of participants receiving their final diagnosis.]
  • RAVLT delayed recall [Time frame: Within 6 months of participants receiving their final diagnosis.]
  • RCFT copy [Time frame: Within 6 months of participants receiving their final diagnosis.]
  • RCFT recall [Time frame: Within 6 months of participants receiving their final diagnosis.]

Eligibility criteria

Inclusion criteria

  • At least one core clinical feature of dementia with Lewy bodies such as visual hallucinations, parkinsonism, cognitive fluctuations, or probable REM sleep behaviour disorder.

Exclusion criteria

  • Causes of cognitive impairment other than those related to dementia or MCI. Current or pass drug use.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska University Hospital — Stockholm

Publications

  • McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz J PMID 28592453
  • Gravett S, Garcia-Ptacek S, Rennie A, Bogdanovic N, Bonnard A, Granberg T, Nordberg A, Jelic V, Ferreira D. Find-DLB: a naturalistic cohort of patients presenting with clinical features of dementia with Lewy bodies to a specialized cognitive clinic. Eur Geriatr Med. 2026 Feb;17(1):309-321. doi: 10.1007/s41999-025-01372-z. Epub 2025 Dec 8. PMID 41354725

Identifiers

NCT: NCT07629349 · 2013-2169-31 · 2022-00916 and 2025-02984

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗