Imaging of tau accumulatio

Phase 1

Active, not recruiting

• Conditions: Alzheimer's Disease (AD), preclincal stages of AD; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10074616Term: Prodromal Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2015-003705-42-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-06
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Clinically diagnosed with 'subjective cognitive decline' after the standardized dementia screening performed at the VUmc Alzheimer Center
- At least 50 years of age
- Enrollment in the FIAD cohort (protocol nr 13-256)
- Have received or will receive a [18F]Florbetapir PET scan 90 days before or after the [18F]AV-1451 PET scan
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Has contraindications for MRI scanning and therefore can not receive brain MRI
- Has evidence for structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan
- Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must not be pregnant or breast feeding at screening.
- 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.;
- Has ever participated in an experimental study with a tau targeting agent, unless it can be documented that the subject received only placebo during the course of the trial;
- Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv
- Has a history of severe traumatic brain injury (TBI)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified