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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment (MCI); Dementia With Lewy Bodies (DLB); Other Dementias; Cognitively Unimpaired

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Daniel Ferreira, Docent, Senior Lecturer; Phone Number: +46720128047; Email: daniel.ferreira.padilla@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 14157
    • Recruiting
    • Karolinska University Hospital
    • Contact: Daniel Ferreira, Docent, Senior Lecturer; Phone Number: +46720128047; Email: daniel.ferreira.padilla@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebrospinal fluid amyloid-beta 1-42	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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).

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Publications and helpful links

General Publications

• McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
• Gravett S, Garcia-Ptacek S, Rennie A, Bogdanovic N, Bonnard A, Granberg T, Nordberg A, Jelic V, Ferreira D. Find-DLB: a naturalistic cohort of patients presenting with clinical features of dementia with Lewy bodies to a specialized cognitive clinic. Eur Geriatr Med. 2026 Feb;17(1):309-321. doi: 10.1007/s41999-025-01372-z. Epub 2025 Dec 8.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: longitudinal; retrospective; case-control
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Cognitive Dysfunction; Lewy Body Disease
• Other Study ID Numbers: 2013-2169-31; 2022-00916 and 2025-02984 (Other Grant/Funding Number: Swedish Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: at any time
• IPD Sharing Access Criteria: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No