Dementia with Lewy bOdies Project (DEvELOP): a longitudinal cohort study in DLB

Dementia with Lewy bOdies Project (DEvELOP): a longitudinal cohort study in DLB - DEvELOP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45751

Enrollment

100

Registered

2016-02-04

Start date

2016-03-08

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lewy body disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Signed informed consent projects P2005/160 (replaced by P2016/061), P2000/211, P2008/230 (will be replaced by P2017/315) . Fulfilling criteria for possible or probable DLB or Mild cognitive impairment (MCI) with at least one core or suggestive DLB feature. Clinical Dementia Rating 18

Exclusion criteria

Exclusion criteria: Severe physical or life-threatening conditions Long-term previous use of antipsychotic drugs No reliable caregiver present Nursing home residency

Design outcomes

Primary

Measure	Time frame
To address the different research questions, the following study parameters will be investigated: - Clinical parameters (cross-sectional and longitudinal): physical/neurological examination, neuropsychological test results; (caregiver) questionnaires concerning neuropsychiatric, extrapyramidal and sleep symptoms, quality of life and daily functioning. - Biomarkers (cross-sectional and longitudinal): CSF proteins (Abeta42, Tau, p-Tau); (patterns of) cerebral atrophy and vascular lesions on Magnetic resonance imaging (MRI); visual rating and quantitative analysis of Electroencephalography (EEG).	—

Measure

Time frame

To address the different research questions, the following study parameters will be investigated: - Clinical parameters (cross-sectional and longitudinal): physical/neurological examination, neuropsychological test results; (caregiver) questionnaires concerning neuropsychiatric, extrapyramidal and sleep symptoms, quality of life and daily functioning. - Biomarkers (cross-sectional and longitudinal): CSF proteins (Abeta42, Tau, p-Tau); (patterns of) cerebral atrophy and vascular lesions on Magnetic resonance imaging (MRI); visual rating and quantitative analysis of Electroencephalography (EEG).

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Countries

Netherlands

Outcome results