The general objective of DEvELOP is to establish a prospective cohort of patients with DLB, to study the longitudinal course of clinical symptoms and biomarkers with a specific focus on concomitant AD pathology. Specific research questions that will…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
Not applicable
Background summary
Dementia with Lewy bodies (DLB) is the second most common form of dementia and
clinically defined by cognitive impairment combined with visual hallucinations,
parkinsonism and/or cognitieve fluctuations. However, it is a heterogeneous
disease with varying symptomatology and disease course in individual patients.
DLB is relatively understudied and especially longitudinal data are lacking.
Pathologically, DLB is characterized by widespread distribution of Lewy bodies
in the brain, although concomitant AD pathology (amyloid plaques and tangles)
is frequently found. The impact of concomitant AD pathology on clinical
manifestation, disease course and biomarkers is unclear. The presence of AD
co-pathology in DLB can be identified ante mortem by analysis of cerebrospinal
fluid (CSF). Therefore, it is now possible to investigate the influence of
concomitant AD pathology on the patient with DLB during life.
Study objective
The general objective of DEvELOP is to establish a prospective cohort of
patients with DLB, to study the longitudinal course of clinical symptoms and
biomarkers with a specific focus on concomitant AD pathology. Specific research
questions that will be addressed include:
1. What is the effect of concomitant AD pathology on clinical phenotype and
cognitive decline?
2. What is the effect of concomitant Alzheimer pathology on structural and
functional changes in the brain?
3. Can AD pathology develop over time in DLB?
4. What is the effect of concomitant AD pathology on response to symptomatic
treatment?
Study design
DEvELOP is a prospective cohort study. The duration of follow-up will be four
years. The value of this cohort lies in the extensive phenotyping of the
participants and the long duration of follow-up. This study is embedded in the
Amsterdam Dementia Cohort, a prospective dementia cohort, that offers the same
standardized multidisciplinary diagnostic work-up to every patient.
Study burden and risks
The risks associated with participation are negligible (risk of headache after
lumbar puncture is reduced to 1-5% by use of atraumatic needle).The burden
mainly consists of time investment, although the investigations at annual
follow-up are mostly part of our current clinical care. Before inclusion,
patients will have been screened at the VUmc Alzheimer center. When patients
participate in DEvELOP, they will undergo additional neuropsychological tests
and a series of questionnaires (estimated time of first visit: one hour for the
patient and 30 mins for caregiver simultaneously). The investigations at annual
follow-up are mostly part of our current clinical care (aprroximately 2 hours).
Furthermore, additional neuropsychological tests and a series of questionnaires
will be conducted as part of the DEveLOP study (estimated time 1 hour). The
total time of the annual follow-ups is approximately 3 hours. At T=0.5 EEG will
be repeated (estimated extra time: 2 hours) and at T=2 MRI and blood and CSF
collection will be repeated (estimated extra time: 1.5 hours).
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55470.029.15 |
| OMON | NL-OMON27253 |