Essais cliniques sur Trouble cognitif léger (MCI), Démence à corps de Lewy (DCL), Autres Démences, Cognitivement Intact - Registre des essais cliniques

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

600

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Daniel Ferreira, Docent, Senior Lecturer
Numéro de téléphone: +46720128047
E-mail: daniel.ferreira.padilla@ki.se

Lieux d'étude

Suède
- - Stockholm, Suède, 14157
    - Recrutement
    - Karolinska University Hospital
    - Contact:
      
      Daniel Ferreira, Docent, Senior Lecturer
      
      Numéro de téléphone: +46720128047
      
      E-mail: daniel.ferreira.padilla@ki.se

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

4

Cohortes et interventions

Groupe / 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.

Que mesure l'étude ?

Principaux critères de jugement

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Karolinska Institutet

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Data from the European DLB consortium is also used in the current study, primarily based on the Swedish Find-DLB cohort

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2020

Achèvement primaire (Estimé)

1 mars 2031

Achèvement de l'étude (Estimé)

1 mars 2031

Dates d'inscription aux études

Première soumission

22 avril 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

2013-2169-31
2022-00916 and 2025-02984 (Autre subvention/numéro de financement: Swedish Research Council)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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

Délai de partage IPD

at any time

Critères d'accès au partage 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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Mesure des résultats	Description de la mesure	Délai
Cerebrospinal fluid amyloid-beta 1-42 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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).

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