The first (primary) objective (study 1) is to examine 1a) risk factors for volume loss in the entorhinal cortex and compare these with risk factors for volume loss in the rest of the hippocampus at 1.5T MRI over 7 years of follow-up; and to examine…
ID
Source
Brief title
Condition
- Structural brain disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome variables for the primary objective are 1a) hippocampal and entorhinal
cortex volume at 1.5T MRI, and 1b) cognitive functioning and late-life
depression after 7 years of follow-up.
Outcome variables for the second objective are 2a) cognitive functioning and
late-life depression, and 2b) volumes of hippocampal subfields at 7T MRI.
Secondary outcome
Not applicable.
Background summary
At older age, depression and cognitive decline are very common, and often
co-occur. However, the nature of the relation between late-life depression and
cognitive decline is not well understood. Vascular brain changes and atrophy of
the hippocampal formation are associated with both depression and cognitive
decline, but they are also commonly observed in normal aging, and are thus
relatively aspecific neurobiological markers for depression and cognitive
decline. At conventional (1.5T- 3T) MRI it is possible to differentiate the
entorhinal cortex from the rest of the hippocampus, and studies indicate that
the entorhinal cortex is affected in an earlier stage of cognitive decline /
Alzheimer*s disease than the rest of the hippocampus. We hypothesize that the
entorhinal cortex and the rest of the hippocampus differentially increase risk
for cognitive decline and late-life depression, and that they are
differentially related to risk factors.
Recently, we made it possible for the first time to visualize and measure the
other subfields within the hippocampus using ultra high field strength (7T)
MRI. We hypothesize that these subfields also are differentially related to
risk factors, cognitive decline and late-life depression.
Study objective
The first (primary) objective (study 1) is to examine 1a) risk factors for
volume loss in the entorhinal cortex and compare these with risk factors for
volume loss in the rest of the hippocampus at 1.5T MRI over 7 years of
follow-up; and to examine 1b) whether the entorhinal cortex and the rest of the
hippocampus differentially increase risk for cognitive decline and late-life
depression over 7 years of follow-up in patients with manifest arterial disease.
The second objective (study 2) is 2a) to examine whether subfields of the
hippocampal formation at 7T MRI are differentially related to cognitive
impairment and late-life depression; and 2b) to explore risk factors of
subfield volume reductions in patients with manifest arterial disease.
Study design
The study design of the primary objective is a prospective cohort study; for
the second objective the design is a cross-sectional study.
Study burden and risks
The burden will consist of a visit to the UMC Utrecht on a normal weekday,
which will take about the whole day and completing an extra questionnaire at
home. Upon suspicion of pregnancy, a pregnancy test will be performed before
the 7T MRI can take place.
The risks will be the possibility of nausea or dizziness during the MRI. These
risks will not result in permanent damage, but only in short-term discomfort.
Universiteitsweg 100
Utrecht 3584 CG
NL
Universiteitsweg 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
All persons still alive who participated in the baseline examination of the SMART-Medea study from 2006 through 2009.
Exclusion criteria
Contra-indications for MR imaging (metal objects in the body, claustrophobia, pregnancy). Terminally ill or physically unable to come to the UMCU.
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 | NL38085.041.12 |