Primary Objective: To examine which subregions of the hippocampal formation on 7 Tesla MRI are most affected in patients with early Alzheimer*s disease compared with older persons with normal cognition. Secondary Objectives:a) To explore risk…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is hippocampal subregion volumes at 7 Tesla MRI.
Secondary outcome
The secondary outcome measure is cognitive functioning.
Background summary
Hippocampal atrophy is one of the distinctive features of Alzheimer*s disease
(AD), distinguishing persons with normal cognition from patients with mild
cognitive impairment (MCI) or dementia. The hippocampal formation consists of
several subregions that are anatomically distinct and may be differently
affected by AD, normal ageing and risk factors. With 7 Tesla MRI, these
subregions can now be visualized for the first time in vivo. This can help to
understand the etiology of normal and pathological brain aging and to
distinguish between normal age-related changes and very early AD.
Study objective
Primary Objective: To examine which subregions of the hippocampal formation on
7 Tesla MRI are most affected in patients with early Alzheimer*s disease
compared with older persons with normal cognition.
Secondary Objectives:
a) To explore risk factors for volume reduction in hippocampal subregions on 7
Tesla MRI in patients with early Alzheimer*s disease and older persons with
normal cognition.
b) To explore the relation between variation in hippocampal subregion volumes
and specific aspects of cognitive functioning, in particular memory, within the
group of patients with early Alzheimer*s disease and within the group of older
persons with normal cognition.
Study design
cross-sectional study
Study burden and risks
All research procedures are executed during a single visit to the UMCU. Health
risks associated with the procedures and techniques used are minimal. The main
burden is the visit to the UMCU to perform the measurements. Furthermore, a
venipunction and MRI scan can be uncomfortable for some people.
At the moment no treatment is known that is able to prevent or cure AD, or to
substantially delay progression of the disease. This study aims to gain insight
in etiology and neurobiological substrate of AD en can contribute to
development of new imaging biomarkers of AD that can be used in future
observational and intervention studies.
Heidelberglaan 100
Utrecht 3582 CX
NL
Heidelberglaan 100
Utrecht 3582 CX
NL
Listed location countries
Age
Inclusion criteria
Patients:
- Age >= 60 years
- Diagnosis problable or possible AD, or a precursor (amnestic MCI)
- Clinical Dementia Rating Scale (CDR) 0.5 or 1
- Mini-Mental State Examination (MMSE) > 20;Persons with normal cognition:
- Age >= 60 years
- No clinical diagnosis of MCI or dementia, or other neurological conditions that affect cognition
- No previous medical evaluations for cognitive complaints
- Clinical Dementia Rating Scale (CDR) 0
Exclusion criteria
Patients and older persons with normal cognition:
- Contra indications for MR imaging (see appendices A and B of research protocol)
- Not being able to understand Dutch language
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 | NL38101.041.11 |