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

Recruiting

Conditions: Lewy body disease
Dementia with visual hallucinations and parkinsonism
10012272

Registration Number: NL-OMON45751

Lead Sponsor: VU Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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 <= 0.5 or 1, and/or MMSE > 18

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures