To determine the intra-individual variation of various potential blood based biomarkers on consecutive days or weeks.
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood material will be processed and concentrations of the protein of interest
will be measured. Intra-individual fluctuations om the protein concentration in
blood over time will be evaluated.
Secondary outcome
n.v.t.
Background summary
Assessing reproducibility of results within persons, across study cohorts and
between laboratories is required prior to clinical implementation of new
biomarkers for neurodegenerative diseases such as Alzheimer*s Disease. Levels
of biomarkers might fluctuate from day to day within persons, caused by for
example diet, sleep fluctuations, or other biorhythms or environmental
influences. Considering biotemporal fluctuations of a new potential biomarker
is needed to adequately calculate sample size of biomarker validation studies
that assess the diagnostic potential of biomarker across study cohorts.4
Additionally, in daily clinical practice, just one sample is collected to
determine the biomarker levels. If a biomarker level fluctuates within a person
over a short period of time, unrelated to disease state, this might result in a
less reliable diagnosis using this biomarker. In this project we focus on the
within-person reproducibility of blood-based biomarker levels; blood biomarker
analysis is a new emerging field for neurodegenerative diseases.
Study objective
To determine the intra-individual variation of various potential blood based
biomarkers on consecutive days or weeks.
Study design
Participants registered with Hersenonderzoek.nl (METc 2016.409) are approached
via Hersenonderzoek.nl to participate in this study. Participants registered in
Amsterdam dementia cohort (METc 2016.061) are approached through an Alzheimer's
Center neurologist or by the executive investigator of this protocol to
participate in this study.
After the participant's permission, blood will be taken via venipuncture, this
will be 35 milliliters per blood sample. The subject will be enrolled in one of
the following protocols:
1) Blood collection on five consecutive days
2) Blood collection on a fixed day of the week for four weeks
Study burden and risks
There will be no significant burden or risk to the volunteers. The volunteer
will donate blood (35 milliliters per collection) via venipuncture on five
consecutive days or on one fixed day per week for four weeks. The total blood
collection per participant will never exceed 175 milliliters. Blood collections
can be painful or cause bruises. There are no direct benefits for the
participants.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- Mentally competent adults > 18 years, who are member of Hersenonderzoek.nl.
Adults are included when they fill out that they do not have cognitive
complains or when they report they have ongoing Alzheimer*s disease on their
question form
- Mentally competent adults > 18 years, who are participants of the Amsterdam
Dementia Cohort and have evidence of ongoing Alzheimer*s disease. Evidence of
ongoing Alzheimer*s disease is screened using cerebrospinal fluid
amyloid-beta42 levels or using an amyloid PET scan that are available through
the Amsterdam Dementia Cohort database.
Exclusion criteria
People with contra-indications for venipuncture. People aged <18 or people that
are mentally incompetent, due to e.g. a degenerative brain disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69851.029.19 |