Klinická studie na Mírná kognitivní porucha (MCI), Demence s Lewyho tělísky (DLB), Jiné demence, Kognitivně neporušený - Registr klinických hodnocení

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

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 studie

Pozorovací

Zápis (Odhadovaný)

600

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Daniel Ferreira, Docent, Senior Lecturer
Telefonní číslo: +46720128047
E-mail: daniel.ferreira.padilla@ki.se

Studijní místa

Švédsko
- - Stockholm, Švédsko, 14157
    - Nábor
    - Karolinska University Hospital
    - Kontakt:
      
      Daniel Ferreira, Docent, Senior Lecturer
      
      Telefonní číslo: +46720128047
      
      E-mail: daniel.ferreira.padilla@ki.se

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dítě
Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta Skupina / kohorta Skupina nebo podskupina účastníků pozorovací studie, která je hodnocena z hlediska biomedicínských nebo zdravotních výsledků.
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 je měření studie?

Primární výstupní opatření

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Karolinska Institutet

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. ledna 2020

Primární dokončení (Odhadovaný)

1. března 2031

Dokončení studie (Odhadovaný)

1. března 2031

Termíny zápisu do studia

První předloženo

22. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

4. června 2026

První zveřejněno (Aktuální)

5. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

2013-2169-31
2022-00916 and 2025-02984 (Jiné číslo grantu/financování: Swedish Research Council)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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

Časový rámec sdílení IPD

at any time

Kritéria přístupu pro sdílení 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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Měření výsledku	Popis opatření	Časové okno
Cerebrospinal fluid amyloid-beta 1-42 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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)