MOPEAD will compare the four different subpopulations with regard to detection of hidden cases of mild cognitive impairment (MCI) due to AD or mild AD dementia using an extensive evaluation of selected individuals using cognition, biomarkers, and…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Risk for Alzheimer dementia, based on extensive evaluation using cognition,
biomarkers, and traditional risk factors (genetic and environmental).
Secondary outcome
To compare the cost-effectivity (of recruitment and pre-screening) of four
different subpopulations to detect individuals with prodromal/mild AD dementia
within the Netherlands. In addition, cost-effectivity will be compared with
findings in the other participating sites in other European countries.
Background summary
Several health economic studies carried out in different countries showed that
identifying AD individuals at an early stage (MCI due to AD or mild AD
dementia) results in cost savings and health benefits compared with no
treatment or treatment in the absence of early assessment. Besides, the
disappointing results of clinical trials carried out in individuals with
dementia have given rise to the idea that interventions have occurred too late
in the disease process. Therefore, from the drug development point of view an
early diagnosis is critically needed to identify optimal candidates for new
clinical trials. Currently, it is unknown how these subjects at high risk of AD
but without dementia can efficiently be detected in the general population. In
this context there is a clear need to test and compare existing and innovative
patient engagement models. Four subpopulations will be evaluated: 1)
participants who sign up for participating via an online platform; 2)
participants that visited an open house or event; 3) participants recruited via
primary care practitioners (GP); 4) participants recruited via tertiary care
based specialists (endocrinologist office).
Study objective
MOPEAD will compare the four different subpopulations with regard to detection
of hidden cases of mild cognitive impairment (MCI) due to AD or mild AD
dementia using an extensive evaluation of selected individuals using
cognition, biomarkers, and traditional risk factors (genetic and environmental)
and compare this between five European countries.
Study design
This is a cross-sectional, observational, pan-European, multicenter
(Netherlands (VUmc); Spain (FACE); Sweden (Karolinska Institute); Slovenia (
SPO); Germany (University of Köln)) study. The protocol of this study is
identical for all participating countries/centers.
Each site will obtain local IRB approval. MOPEAD is a European multi-country
project approved and supported by the Innovative Medicines Initiative (IMI). It
will be carried out by a consortium of 14 members (Table 1), including academic
institutions, pharmaceutical industry, technological companies and relevant
stakeholders such as patient associations, as shown below.
Duration of the study
The study includes 1 visit that takes place at the Alzheimer center of the VU
Medical Center with a duration of approximately 5 hours. The visit is described
in more detail in chapter 5.2.
Follow-up from Prescreening protocol (METc 2018.057)
The Prescreening phase of this protocol will be performed under a separate
protocol (METc 2018.057). During prescreening, non-demented participants will
be recruited from four different subpopulations: 1) participants who sign up
for participating via an online platform; 2) participants that visited an open
house or event; 3) participants recruited via primary care practitioners
(general practitioners); 4) participants recruited via tertiary care based
specialists (endocrinologists office). This screening consists of a short
neuropsychological test and several questionnaires. Based on the data of each
participant of the prescreening, we will check for inclusion- and exclusion
criteria for MOPEAD (this protocol).
Study burden and risks
The visit at VUmc will take approximately 5 hours, including neurological
examination, neuropsychological assessment, blood sampling, APOE genotyping and
MRI. Optionally, CSF sampling will be performed. All procedures used in this
study are medical routine procedures, therefore the risks are negligible.
De Boelelaan 1117
Amsterdam 1081HZ
NL
De Boelelaan 1117
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
- aged between 65-85 years.
- without a previous diagnosis of cognitive impairment
- a reliable informant
- capable to speak Dutch;Additional criteria applied for the specific subpopulations:
Subpopulation 1) Online
* - Visitors of the online platform
* - CANTAB score below the pre-fixed cut-off (adjusted by age and education) on the online cognitive tests. The cut-off will be determined in association with Cambridge Cognition based on already collected data in participants with normal cognition, MCI and dementia.;Subpopulation 2) Open house or event
* - Visitors of an open house or event which are recruited by advertisements or via Hersenonderzoek.nl.
* Any of the following:
- MMSE between 20-27 or
- FSCRT total score <1.5 SD below the normal score for age and education or
- FCSRT total score between 1 * 1.5 SD + 3 positive answers to SCD questions.;Subpopulation 3) Primary care
* - Patients visiting their GP.
* - Individuals with available data in the medical records needed for calculate CAIDE Dementia Risk Score and check out the exclusion criteria.
* Any of the following:
- MMSE between 20-27 or
- New CAIDE risk score suggesting high risk of dementia.
- New CAIDE Risk Score suggesting medium risk of dementia + 3 positive answers to SCD questions.;Subpopulation 4) Tertiary care
* - Patients visiting the endocrinology department of VUmc.
* - With a diagnosis of type 2 diabetes mellitus.
* Individuals with available data in the medical records needed for calculate DSDRS (reliable data on the medical records regarding: age, level of education, history of acute metabolic events, history of diabetic foot, history of microvascular disease, history of cerebrovascular disease, history of cardiovascular disease, diagnosis of depression) and check out exclusion criteria.
* - Reliable data on microalbuminuria and funduscopy of the 12 previous months.
* - At least 2 determinations of HbA1c in the 2 previous years.
* Any of the following:
- MMSE between 20-27 or
- DSDRS> 10
- DSDRS 7-10 + 3 positive answers to SCD questions.
Exclusion criteria
- Severe visual or hearing impairment that could interfere with the assessment.
- History of traumatic brain injury involving loss of consciousness.
- History of stroke (symptoms lasting more than 24 hours), epilepsy, demyelinating disease, parkinsonism, CNS infection.
- Current symptoms of major depression.
- Presence of severe metabolic or systemic disease that could be responsible for the cognitive symptoms in the opinion of the investigator.
- Treatment with psychotropic medications that could significantly interfere with cognition in the opinion of the investigator.
- A previous diagnosis of cognitive impairment.
- Any contraindication to undergo MRI (claustrophobia, incompatible pacemakers, metallic medical devices, etc).
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 | NL63046.029.17 |