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Clinical Trials/EUCTR2018-004466-34-NL
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.

Registry
who.int
Start Date
December 19, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amsterdam UMC VUmc

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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