軽度認知障害 (MCI)、レビー小体型認知症（DLB）、その他の認知症、認知機能が正常の臨床試験-臨床試験登録-ICH GCP

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

600

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Daniel Ferreira, Docent, Senior Lecturer
電話番号：+46720128047
メール：daniel.ferreira.padilla@ki.se

研究場所

スウェーデン
- - Stockholm、スウェーデン、14157
    - 募集
    - Karolinska University Hospital
    - コンタクト：
      
      Daniel Ferreira, Docent, Senior Lecturer
      
      電話番号：+46720128047
      
      メール：daniel.ferreira.padilla@ki.se

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

子
大人
高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

4

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Karolinska Institutet

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年1月1日

一次修了 (推定)

2031年3月1日

研究の完了 (推定)

2031年3月1日

試験登録日

最初に提出

2026年4月22日

QC基準を満たした最初の提出物

2026年6月4日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月5日

QC基準を満たした最後の更新が送信されました

2026年6月4日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

2013-2169-31
2022-00916 and 2025-02984 (その他の助成金/資金番号：Swedish Research Council)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

at any time

IPD 共有アクセス基準

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

結果測定	メジャーの説明	時間枠
Cerebrospinal fluid amyloid-beta 1-42 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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)