The objective is to identify which eye movement features are sensitive biomarkers for FTD. To answer this question, we will assess which eye movement features dissociate best between healthy controls, patients with FTD (familial and non-familial),…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Eye movement features derived from the eye-tracking test battery.
Secondary outcome
Not applicable
Background summary
Frontotemporal dementia (FTD) is a clinical, pathological and genetically
heterogeneous neurodegenerative disorder. In up to 30% of cases FTD is
inherited in an autosomal dominant inheritance pattern, with the most common
mutations occurring in the microtubule-associated protein tau (MAPT),
progranulin (GRN), and chromosome 9 open reading frame 72 (C9orf72) genes. As a
result, we can define mutation carriers in the presymptomatic phase. Since
2009, a large cohort of at-risk mutation carriers are being followed in the
Erasmus MC, called the FTD Risk Cohort (FTD-RisC). Research in familial FTD has
demonstrated that disease pathology already emerges years before symptom onset,
and is associated with subtle cognitive changes as measured by
neuropsychological examination. For upcoming medication trials, sensitive
biomarkers to assess disease stage and track progression are crucial. Cognitive
measures could serve as biomarkers, however, standard neuropsychological
assessment lacks sensitivity. We hypothesize that eye movement features could
serve as a sensitive biomarker for FTD.
Study objective
The objective is to identify which eye movement features are sensitive
biomarkers for FTD. To answer this question, we will assess which eye movement
features dissociate best between healthy controls, patients with FTD (familial
and non-familial), patients with Alzheimer*s dementia (AD), and presymptomatic
FTD mutation carriers.
Study design
This is an observational study. A range of eye-tracking tests that have been
related to FTD and AD in previous research will be administered, including
pro-/anti-saccade, oculomotor capture, smooth pursuit, self-paced eye
movements, Brixton spatial anticipation, and free viewing. Clinical data will
be retrieved from the FTD Risk Cohort study (FTD-RisC; MEC-2009-409) study, and
dementia biobank (MEC-2016-069).
Study burden and risks
Patients with FTD and AD will be assessed in a single research session lasting
2-3 hours. Presymptomatic mutation carriers and healthy controls will be
assessed on a (two) yearly basis, in combination with their FTD-RisC follow-up
appointment. A (non-invasive) eye-tracking test battery is administered during
which gaze position is recorded. Eye-movements are made frequently in daily
life, without any conscious effort. Making eye movements in the suggested test
battery will not cause discomfort, as we will investigate participants* normal
viewing behaviour. It might occur that eye fatigue is experienced, as the tests
take part in a dimly lit room. This burden is, however, minimal. To minimize
burden, breaks are provided during and in between tests.
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Listed location countries
Age
Inclusion criteria
1) Patients with FTD referred to our referral center and diagnosed with use of
International
Consensus Criteria. The dementia symptoms have to be mild (clinical dementia
rating <=1). Patients with all variants of FTD (behavioural frontotemporal
dementia, semantic variant PPA, non-fluent variant PPA) will be included.
2) Patients with mild Alzheimer's dementia diagnosed according to International
Consensus Criteria. The dementia has to be mild (clinical dementia rating <=1).
3) Asymptomatic, first degree relatives of dementia patients due to genetic
mutations. They have 50% chance of having the mutation and developing FTD. DNA
status is determined in a related study (MEC-2009-409) in a double-blind
design. Participation is possible from 18 years and over.
Exclusion criteria
Subjects with a previous stroke or other (neurological) conditions that may
affect cognitive functions (brain tumour, multiple sclerosis, use of
psycho-active medications) will be excluded from participation in this study.
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 | NL80727.078.22 |