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

4 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

600

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Zweden
      • Stockholm, Zweden, 14157
        • Werving
        • Karolinska University Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cerebrospinal fluid amyloid-beta 1-42
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Karolinska Institutet

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2020

Primaire voltooiing (Geschat)

1 maart 2031

Studie voltooiing (Geschat)

1 maart 2031

Studieregistratiedata

Eerst ingediend

22 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

4 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2013-2169-31
  • 2022-00916 and 2025-02984 (Ander subsidie-/financieringsnummer: Swedish Research Council)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

at any time

IPD-toegangscriteria voor delen

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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