Plasma P-tau2017 and Quantitative Amyloid PET Imaging

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Amyvid

• Registration Number: NCT05164536
• Lead Sponsor: Invicro

Brief Summary

The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels.

Detailed Description

The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels. Other relevant AD-related investigational biomarkers may also be assessed in the provided samples. Apolipoprotein E (ApoE) genetic status will be evaluated with a serum sample.

Study Timeline

• Study Start: 2021-08-27
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-20
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2023-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]Florbetapir	Amyvid	Participants will undergo amyloid PET imaging with an approved amyloid radiotracer (ie, \[18F\]Florbetapir (Amyvid™)) to assess β-amyloid neuritic plaque density.

Primary Outcome Measures

Name	Time	Method
Creation of a database of brain amyloid deposition by region using PET signal-to-noise ratio, SUVr .	1 year	Amyloid PET imaging will be used to measure regional brain amyloid deposition in each subject.

Secondary Outcome Measures

Name	Time	Method
Creation of a database of blood P-tau217 and other blood biomarkers.	1 year	Blood will be analyzed at Eli Lilly for P-tau217 and ApoE genotype. The analysis will be described in a separate analysis plan.

Trial Locations

Locations (1)

Invicro; 🇺🇸 New Haven, Connecticut, United States