* To implement a standardised MRI acquisition protocol in multiple centres across Europe (Part A).* To identify and evaluate new biomarkers of disease progression in patients with amnestic MCI by collecting biochemical, neuroimaging,…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes of the hippocampal volume between the two groups (CSFP and CSFN) and
within the same group over time.
Secondary outcome
* Neuropsychological progression and conversion to dementia.
* Change in structural, functional, neurophysiological, biochemical biomarkers
and their combination, i.e. MATRIX and their correlation with change in
cognition and hippocampal volume.
Background summary
In order to facilitate drug development in Alzheimer*s disease (AD) there is an
urgent need for markers for early diagnosis and disease progression. Subjects
with Mild Cognitive Impariment (MCI) are at an increased risk to develop
AD-type dementia and may be candiates for early intervention studies.
Study objective
* To implement a standardised MRI acquisition protocol in multiple centres
across Europe (Part A).
* To identify and evaluate new biomarkers of disease progression in patients
with amnestic MCI by collecting biochemical, neuroimaging, neuropsychological
and neurophysiological data in MCI patient with high and low CSF levels of
Abeta 42 and follow those patients over time to evaluate the sensitivity for
disease progression of each biomarker individually or in combination, and see
how those biomarkers correlate with patients cognitive decline (Part B).
Study design
Multi-center longitudinal cohort study
Study burden and risks
Burden:
Participants are patients with a diagnosis of Mild Cognitive Impairment (MCI)
without dementia. During two years they will undergo four times a
neuropsychological assessment, four MRI's will be made and two lumbar punctures
will be done. Similar research showed that burden is acceptable voor these
patients.
Risk:
Taking spinal fluid constitutes no significant risk. During this procedure,
subjects may have temporary pain and discomfort in your back. The puncture
causes headaches in fewer than 4% of cases, and such headaches will subside
after a few days at the most. Removal of blood by a needle and syringe can
occasionally be painful, but this is temporary. Some people may experience
fainting or dizziness, and there is a slight possibility to have infection at
the site of the needle stick. MRI can be regarded as a safe neuroimaging
technique. An MRI may cause possible anxiety due to the loud banging made by
the machine and the confined space of the testing area. Subjects will be
informed that they are free to withdraw at any time during the study should
they experience excessive anxiety or malaise.
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xx
Marseille 13001
NL
xx
Marseille 13001
NL
Listed location countries
Age
Inclusion criteria
Patients with a diagnosis of Mild Cognitive Impairment, aged 55-90 years and memory complaints verified by a physician and on cognitive testing.
Exclusion criteria
Ischaemic lesions
Head injury with loss of consciousness > 24 hours
Current substance abuse or therapy with steroids or chemotherapy
Systemic disease with frequent involvement of the CNS
CNS disease diagnosed or in treatment
Inadequate for neuropsychological testing
Enrolment in other trials/studies not compatible with this study
Use of specific medication
(History of) neurological/psychiatric illnesses
Ferromagnetic implants and devices not eligible for MRI scanning
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 | NL43073.029.13 |