Tau accumulation in healthy elderly
- Conditions
- Cognitively healthy elderly, aged 60-100 years old.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-004466-34-NL
- Lead Sponsor
- Amsterdam UMC VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
Inclusion in PreclinAD study (2014.210) and a subject must be older than 60 years and have received an [18F]flutemetamol amyloid PET scan and/or have a known amyloid status obtained from CSF.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
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;
4.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.;
5.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;
6.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[25].
7.Has a history of severe traumatic brain injury (TBI).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To investigate the effect of amyloid status (positive versus negative) on [18F]AV-1451 binding in cognitively normal individuals. <br>2. To investigate the contribution of genetic factors and non-genetic factors to tau accumulation and its interaction with amyloid accumulation.;Secondary Objective: 1. To investigate the relation of [18F]AV-1451 binding with other AD-markers:<br>-Neuropsychological performance<br>-Grey matter volume on MRI<br>-CSF measures of total tau, phosphorylated tau and amyloid-ß 1-42 and ß 1-40<br>2.To investigate the relation of tau accumulation with AD risk factors collected in the PreclinAD study (2014.210): <br>-Age<br>-Education<br>-APOE genotype<br>;Primary end point(s): Quantitative assessment of tau accumulation, as measured with [18F]AV-1451.;Timepoint(s) of evaluation of this end point: continous PET scan from 0-30 and 80-100 minutes post injection at baseline
- Secondary Outcome Measures
Name Time Method Secondary end point(s): .- Amyloid status, based on the quantitative assessment of amyloid load, as measured with [18F]Flutemetamol or CSF amyloid;<br>- Neuropsychological performance, grey matter volume on MRI, CSF tau and amyloid concentrations; <br>- AD risk factors: age, APOE genotype and education.<br>;Timepoint(s) of evaluation of this end point: continous PET scan from 0-30 and 80-100 minutes post injection at baseline