EUCTR2018-004466-34-NL
Active, not recruiting
Phase 1
Tau PET imaging in cognitively normal elderly subjects: A twin approach - Tau Twin
Amsterdam UMC VUmc0 sites80 target enrollmentDecember 19, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cognitively healthy elderly, aged 60-100 years old.
- Sponsor
- Amsterdam UMC VUmc
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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;
- •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).
Outcomes
Primary Outcomes
Not specified
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