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

4 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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 de estudio

De observación

Inscripción (Estimado)

600

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Suecia
      • Stockholm, Suecia, 14157
        • Reclutamiento
        • Karolinska University Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cerebrospinal fluid amyloid-beta 1-42
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Karolinska Institutet

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2020

Finalización primaria (Estimado)

1 de marzo de 2031

Finalización del estudio (Estimado)

1 de marzo de 2031

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2013-2169-31
  • 2022-00916 and 2025-02984 (Otro número de subvención/financiamiento: Swedish Research Council)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Marco de tiempo para compartir IPD

at any time

Criterios de acceso compartido de 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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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