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

4 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

600

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Szwecja
      • Stockholm, Szwecja, 14157
        • Rekrutacyjny
        • Karolinska University Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Cerebrospinal fluid amyloid-beta 1-42
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Karolinska Institutet

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2020

Zakończenie podstawowe (Szacowany)

1 marca 2031

Ukończenie studiów (Szacowany)

1 marca 2031

Daty rejestracji na studia

Pierwszy przesłany

22 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2013-2169-31
  • 2022-00916 and 2025-02984 (Inny numer grantu/finansowania: Swedish Research Council)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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

Ramy czasowe udostępniania IPD

at any time

Kryteria dostępu do udostępniania 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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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