가벼운 인지 장애(MCI), 루이소체 치매(DLB), 기타 치매, 인지 기능이 정상인에 대한 임상 시험 - 임상 시험 레지스트리

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

600

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Daniel Ferreira, Docent, Senior Lecturer
전화번호: +46720128047
이메일: daniel.ferreira.padilla@ki.se

연구 장소

스웨덴
- - Stockholm, 스웨덴, 14157
    - 모병
    - Karolinska University Hospital
    - 연락하다:
      
      Daniel Ferreira, Docent, Senior Lecturer
      
      전화번호: +46720128047
      
      이메일: daniel.ferreira.padilla@ki.se

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

4

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Karolinska Institutet

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 1월 1일

기본 완료 (추정된)

2031년 3월 1일

연구 완료 (추정된)

2031년 3월 1일

연구 등록 날짜

최초 제출

2026년 4월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 4일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

2013-2169-31
2022-00916 and 2025-02984 (기타 보조금/기금 번호: Swedish Research Council)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

at any time

IPD 공유 액세스 기준

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

결과 측정	측정값 설명	기간
Cerebrospinal fluid amyloid-beta 1-42 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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)