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Dementia With Lewy Bodies: Clinical Symptoms, Biomarkers and Progression (Find-DLB)

4 giugno 2026 aggiornato da: Daniel Ferreira, Karolinska Institutet
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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

600

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Svezia
      • Stockholm, Svezia, 14157
        • Reclutamento
        • Karolinska University Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Participants are recruited from cognitive clinics in Stockholm, Sweden; and data is combined with other national and international cohorts

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
MCI
The MCI group consists of participants diagnosed with mild cognitive impairment (MCI), in accordance with clinical consensus criteria. This can be of MCI-Lewy body type, MCI-Alzheimer´s disease type, MCI-Parkinson´s disease type, or MCI-other type
DLB
The DLB group consists of participants diagnosed with dementia with Lewy bodies (DLB) according to clinical criteria from the international consensus.
Cognitively Unimpaired
The Cognitively Unimpaired group refers to those participants without indications of cognitive impairment, including two subgroups: healthy controls and people with subjective cognitive decline
Other Dementias
The Other Dementias group includes participants diagnosed with forms of dementia other than dementia with Lewy bodies (e.g., Alzheimer's disease, Parkinson's disease dementia), as well as those with dementia not otherwise specified.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cerebrospinal fluid amyloid-beta 1-42
Lasso di tempo: Data for this outcome are collected at baseline.
Cerebrospinal fluid (CSF) amyloid-beta 1-42 was coded as normal/abnormal/unknown based on centre-specific cutoffs. CSF samples were obtained from the Karolinska Institutet GEDOC Biobank (Stockholm, Sweden).
Data for this outcome are collected at baseline.
Cerebrospinal fluid phosphorylated tau 181
Lasso di tempo: Data for this outcome are collected at baseline.
Cerebrospinal fluid (CSF) phosphorylated tau 181 was coded as normal/abnormal/unknown based on centre-specific cutoffs. CSF samples were obtained from the Karolinska Institutet GEDOC Biobank (Stockholm, Sweden).
Data for this outcome are collected at baseline.
DaT-Scan
Lasso di tempo: Data for this outcome are collected at baseline.
Dopamine transporter scan (DaT-Scan) was coded as normal/abnormal/unknown based on visual assessment as per established diagnostic criteria.
Data for this outcome are collected at baseline.
MRI
Lasso di tempo: Data for this outcome are collected at baseline.
Magnetic Resonance Imaging (MRI) images were coded as normal/abnormal/unknown based on visual assessment as per established diagnostic criteria.
Data for this outcome are collected at baseline.
EEG
Lasso di tempo: Data for this outcome are collected at baseline.
Electroencephalography (EEG) was coded as normal/abnormal/unknown based on visual assessment as per established diagnostic criteria.
Data for this outcome are collected at baseline.
FDG-PET
Lasso di tempo: Data for this outcome are collected at baseline.
Fluorodeoxyglucose-Positron Emission Topography (FDG-PET) was coded as normal/abnormal/unknown based on visual assessment as per established diagnostic criteria.
Data for this outcome are collected at baseline.
RAVLT
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
Rey Auditory Verbal Learning Test (RAVLT) was used to assess memory, with participants' scores recorded across five learning trials. Total scores ranged from 0 to 75, with a maximum raw score of 15 per trial. Higher scores indicate better memory performance.
Within 6 months of participants receiving their final diagnosis.
RAVLT delayed recall
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
Rey Auditory Verbal Learning Test (RAVLT) delayed recall assesses participants' memory based on the number of words recalled from a 15-word list after 30 minutes of learning. Total scores can thus range from 0 to 15. Higher scores indicate better memory performance.
Within 6 months of participants receiving their final diagnosis.
RCFT copy
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
Rey Complex Figure Test (RCFT) copy was used to assess participants' visuospatial abilities. Performance is evaluated based on the reproduction of 18 figure elements, each scored on a scale from 0 to 2 (0 = incorrectly placed/absent; 0.5 = inaccurately drawn/incorrectly placed but recognisable; 1 = accurately drawn but poorly placed/incomplete but correctly placed; 2 = accurately drawn and correctly placed), yielding a maximum raw score of 36. Higher scores reflect better performance.
Within 6 months of participants receiving their final diagnosis.
RCFT recall
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
Rey Complex Figure Test (RCFT) immediate recall was used to assess participants' memory by requiring them to reproduce a complex figure from memory after a short delay. Performance is evaluated based on the reproduction of 18 figure elements, each scored on a scale from 0 to 2 (0 = incorrectly placed/absent; 0.5 = inaccurately drawn/incorrectly placed but recognisable; 1 = accurately drawn but poorly placed/incomplete but correctly placed; 2 = accurately drawn and correctly placed), yielding a maximum raw score of 36. Higher scores reflect better performance.
Within 6 months of participants receiving their final diagnosis.
Information
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Information subtest of the Wechsler Adult Intelligence Scale (WAIS) was used to assess participants' verbal comprehension. The subtest comprises 26 dichotomously scored questions (0 = incorrect; 1 = correct), with a maximum raw score of 26. Higher scores indicate better performance.
Within 6 months of participants receiving their final diagnosis.
Similarities
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Similarities subtest of the Wechsler Adult Intelligence Scale (WAIS) was used to assess participants' verbal reasoning. Consisting of 18 pairs of words, for which participants are asked to describe how the items are similar, responses are scored on a 3-point scale (0 = incorrect; 1 = functional/concrete; 2 = abstract). Raw scores range from 0 to 36, with higher scores indicating better performance.
Within 6 months of participants receiving their final diagnosis.
Block Design
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Block Design subtest of the Wechsler Adult Intelligence Scale (WAIS) assesses participants' visuospatial abilities. Performance is scored based on the accuracy and speed in reproducing geometric patterns. While the first few items are simple and scored on a 2-point scale (0 = inaccurate; 2 = accurate), later items become more complex and thus yield higher scores (ranging from 0 to 7 depending on the speed of completion). Total scores range from 0 to 66, where higher scores indicate better performance.
Within 6 months of participants receiving their final diagnosis.
Digit Span
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS) was administered to assess participants' working memory and attention. Participants repeated digit sequences of increasing length, with each trial scored as correct or incorrect. The span length of digits to be recalled ranged from 2 to 9 for the forward and sequencing conditions and from 2 to 8 for the backward condition. Total scores range from 0 to 48, with higher scores indicating better performance.
Within 6 months of participants receiving their final diagnosis.
Coding
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Coding subtest of the Wechsler Adult Intelligence Scale (WAIS) was used to assess processing speed. Within a 120-second time limit, participants are required to transcribe symbols paired with digits as quickly and accurately as possible. Performance is scored as the number of correctly completed symbols (0 = incorrect; 1 = correct), with higher scores indicating better performance.
Within 6 months of participants receiving their final diagnosis.
Arithmetic
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Arithmetic subtest of the Wechsler Adult Intelligence Scale (WAIS) was administered to assess working memory and processing speed. Participants solved 22 orally presented arithmetic problems. Performance was scored as the number of correct answers, with one point awarded per correct item (minimum = 0; maximum = 22). Higher scores indicate better performance.
Within 6 months of participants receiving their final diagnosis.
Matrix Reasoning
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Matrix Reasoning subtest of the Wechsler Adult Intelligence Scale (WAIS) was used to assess logical thinking. Comprising 26 items of increasing difficulty, participants identify patterns and select the correct missing piece from several response options. Responses are scored dichotomously (0 = incorrect; 1 = correct), yielding a total score ranging from 0 to 26. Higher scores indicate better performance.
Within 6 months of participants receiving their final diagnosis.
TMT A
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Trail Making Test A (TMT-A) was administered to assess attention and processing speed. Performance is measured by the time required to sequentially connect numbered dots in ascending order, with longer completion times indicating worse performance.
Within 6 months of participants receiving their final diagnosis.
TMT B
Lasso di tempo: Within 6 months of participants receiving their final diagnosis.
The Trail Making Test B (TMT-B) was administered to assess executive functioning. Performance is measured by the time required to connect numbered and lettered dots in an alternating ascending order, with longer completion times indicating worse performance.
Within 6 months of participants receiving their final diagnosis.
Parkinsonism
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
Presence of parkinsonism was determined based on clinical interviews with participants. Responses were coded as present/absent/unknown for parkinsonism symptoms.
From enrollment to the end of the diagnostic rounds (typically 3 months).
UPDRS-III
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
The Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) was administered to assess the presence and severity of parkinsonian motor symptoms. The scale comprises 33 items rated on a 5-point scale (0 = normal to 4 = severe), with higher scores indicating greater motor impairment (minimum = 0; maximum = 132).
From enrollment to the end of the diagnostic rounds (typically 3 months).
Visual hallucinations
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
The presence of visual hallucinations was assessed based on clinical interviews. Responses were coded as either present/absent/unknown.
From enrollment to the end of the diagnostic rounds (typically 3 months).
NPI
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
The Neuropsychiatric Inventory (NPI) was used to assess the presence of visual hallucinations. Responses were evaluated across three stages: presence, frequency, and severity. Presence of visual hallucinations was coded dichotomously as "Yes" or "No". Frequency was rated on a 4-point scale ranging from 1 (occasionally) to 4 (very frequently), whereas severity was rated on a 3-point scale ranging from 1 (mild) to 3 (severe). Domain scores were calculated by multiplying frequency and severity scores, resulting in a total score ranging from 0 to 12. Higher scores indicate greater impairment from visual hallucinations.
From enrollment to the end of the diagnostic rounds (typically 3 months).
Cognitive fluctuations
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
Clinical interviews were used to assess the presence of cognitive fluctuations. Responses were coded as present/absent/unknown.
From enrollment to the end of the diagnostic rounds (typically 3 months).
Mayo Fluctuations Scale
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
The Mayo Fluctuations Scale was administered to assess cognitive fluctuations. The scale comprises four dichotomous questions (0 = no; 1 = yes), with total scores ranging from 0 to 4. Higher scores thus indicate greater impairment.
From enrollment to the end of the diagnostic rounds (typically 3 months).
REM Sleep Behaviour Disorder
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
Clinical interviews were used to assess the presence of REM Sleep Behaviour Disorder (RBD). Responses were coded as present/absent/unknown.
From enrollment to the end of the diagnostic rounds (typically 3 months).
Mayo Sleep Questionnaire
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
The Mayo Sleep Questionnaire is a 16-item instrument used to assess the presence of REM Sleep Behaviour Disorder (RBD). Items are answered dichotomously (0 = no; 1 = yes). The likelihood of RBD is estimated by summing the "yes" responses to the four key RBD sub-questions, yielding a total score ranging from 0 (low likelihood of RBD) to 4 (high likelihood of RBD).
From enrollment to the end of the diagnostic rounds (typically 3 months).
Polysomnography
Lasso di tempo: From enrollment to the end of the diagnostic rounds (typically 3 months).
Polysomnography was used to assess the presence of REM Sleep Behaviour Disorder (RBD) according to standard clinical assessment. Polysomnographic findings were coded as present/absent/unknown for the diagnosis of RBD.
From enrollment to the end of the diagnostic rounds (typically 3 months).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Karolinska Institutet

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2020

Completamento primario (Stimato)

1 marzo 2031

Completamento dello studio (Stimato)

1 marzo 2031

Date di iscrizione allo studio

Primo inviato

22 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2013-2169-31
  • 2022-00916 and 2025-02984 (Altro numero di sovvenzione/finanziamento: Swedish Research Council)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

IPD data from primary and secondary outcomes as well as grouping can be shared with any qualified researcher at a reasonable request to daniel.ferreira.padilla@ki.se, provided that data sharing aligns with current regulations

Periodo di condivisione IPD

at any time

Criteri di accesso alla condivisione IPD

IPD data can be shared with any qualified researcher at a reasonable request to daniel.ferreira.padilla@ki.se, provided that data sharing aligns with current

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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