ongitudinal imaging of tau accumulation in the preclinical stages of AD

Phase 2

Recruiting

• Conditions: first symptoms of Alzheimer's disease; preclinical Alzheimer's disease; 10012272

• Registration Number: NL-OMON50737
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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

Exclusion Criteria

- Has contraindications for MRI scanning and therefore has not received 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-Prinicipal 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 or amyloid
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: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change of [18F]AV-1451 binding in time</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Amyloid positivity, as measured by [18F]Florbetapir PET scan<br /><br>2. Cognitive fucntioning in neuropsychological testing<br /><br>3. Baseline grey matter atrophy on MRI<br /><br>4. Baseline CSF measures of amyloid-beta 1-42, total tau, phosphorylated tau</p><br>