This study has been transitioned to CTIS with ID 2024-517634-17-01 check the CTIS register for the current data. The main objectives are to 1) investigate the relation between (longitudinal) tau and amyloid accumulation in cognitively normal…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoints are the association of (longitudinal) tau pathology with amyloid
pathology (CSF and/or PET) and the correlation in (longitudinal) tau pathology
within monozygotic twin pairs.
Secondary outcome
Secondary endpoints are the relation between (longitudinal) tau and
neuropsychological performance, magnetic resonance imaging(MRI), CSF measures
and AD risk factors.
Background summary
Alzheimer*s disease (AD) is the most common type of dementia, characterized by
progressive neurodegeneration and a gradual onset of cognitive impairment.
Abnormal accumulation of beta amyloid (Aβ) is the first event in AD and is
present in 20-40% of cognitively normal elderly. The accumulation of Aβ is
considered a necessary, but not sufficient, step towards the development of AD
dementia. The accumulation of a second protein, tau, is argued to be closer
related to cognitive decline.
The recent introduction of [18F]AV-1451 allows visualization and quantification
of tau pathology in the living human brain. As such, [18F]AV-1451 potentially
represents the first in vivo biomarker to detect the distribution of tau
pathology in the brain. Whole brain imaging with PET sheds light on the
question whether and how tau binding correlates with cognitive symptoms,
amyloid pathology and cerebral atrophy.
Study objective
This study has been transitioned to CTIS with ID 2024-517634-17-01 check the CTIS register for the current data.
The main objectives are to 1) investigate the relation between (longitudinal)
tau and amyloid accumulation in cognitively normal individuals, 2) test the
contribution of genetic and non-genetic factors on (longitudinal) tau binding
in twins, and 3) test the relation of (longitudinal) tau accumulation with
other AD-markers collected in the PreclinAD study. The study will be an add-on
to the ongoing Amyloid pathology in cognitively normal elderly subjects
(PreclinAD) study (METC 2014.210).
Study design
Prospective, observational study.
Intervention: Subjects will undergo a [18F]AV-1451 PET scan at baseline and 4
year follow-up.
Study burden and risks
Risks associated with participation in this study are related to 1) radiation
exposure 2) idiosyncratic reaction to the tracer, and 3) discomfort during
scanning 4) study in healthy twins, this group is crucial for studying the
earliest pathophysiological changes and the contribution of genetic factors in
AD development.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion in PreclinAD study (2014.210) and a subject must be older than 60
years, have received an [18F]flutemetamol amyloid PET scan and/or have a known
amyloid status obtained from CSF.
Exclusion criteria
1.Has contra indications for MRI scanning and therefore has not received brain
MRI;
2.Has evidence of structural abnormalities such as major stroke or mass on MRI
that is likely to interfere with interpretation of PET scan;
3.Has a relevant history of severe drug allergy or hypersensitivity. Relevant
severe drug allergies should be determined by the Principal Investigator or
Co-Principal Investigator, and any questions about a subject*s eligibility can
be directed to Avid Radiopharmaceuticals Inc.;
4.Has ever participated in an experimental study with a tau agent, unless it
can be documented that the subject received only placebo during the course of
the trial;
5.Has been injected with a previously administered radiopharmaceutical within 6
terminal half-lives or when total yearly radiation exposure exceeds 16.1 mSv
for female and 22.4 mSv for male participants.
6.Has a history of severe traumatic brain
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EU-CTR | CTIS2024-517634-17-01 |
| EudraCT | EUCTR2018-004466-34-NL |
| CCMO | NL68339.029.18 |