Dementia With Lewy Bodies: Clinical Symptoms, Biomarkers and Progression

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least one core clinical feature of dementia with Lewy bodies such as visual hallucinations, parkinsonism, cognitive fluctuations, or probable REM sleep behaviour disorder.

Disqualifiers

Causes of cognitive impairment other than those related to dementia or MCI. Current or pass drug use.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 4 trial groups
Group A: MCI
Group B: DLB
Group C: Cognitively Unimpaired
Group D: Other Dementias

Trial outcomes

Primary outcomes

1

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).

Time frame
Data for this outcome are collected at baseline.
2

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).

Time frame
Data for this outcome are collected at baseline.
3

DaT-Scan

Dopamine transporter scan (DaT-Scan) was coded as normal/abnormal/unknown based on visual assessment as per established diagnostic criteria.

Time frame
Data for this outcome are collected at baseline.
4

MRI

Magnetic Resonance Imaging (MRI) images were coded as normal/abnormal/unknown based on visual assessment as per established diagnostic criteria.

Time frame
Data for this outcome are collected at baseline.

Secondary outcomes

Other outcomes

Sponsors and contacts

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