Plasma P-tau2017 and Quantitative Amyloid PET Imaging

Plasma P-tau2017 and Quantitative Amyloid PET Imaging in a Cognitively Normal Population

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Amyvid

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (for all participants):

• Signed and dated written informed consent obtained from the subject.
• Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method for male participants for the study duration.
• Male participants must not donate sperm for the study duration.
• Willing and able to cooperate with study procedures.
• Males and females.
• Participants aged ≥ 70, inclusive, at the time of Screening.
• Judged to be cognitively normal by an Investigator based on clinical judgment.

Exclusion Criteria (for all participants):

• Subject has received an investigational drug or device within 30 days of enrollment, unless in the opinion of the Investigator such medication or device will not impair subject safety or scientific integrity of the data.
• Contraindication to amyloid PET imaging or blood sampling.
• Have ever received an experimental or approved medication targeting amyloid or tau.
• Prior participation in other research protocols or clinical care in the last year that would result in radiation exposure exceeding the acceptable annual limit established by the U.S. Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
• Pregnancy, lactating or breastfeeding.
• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease that in the Investigator's judgment may interfere with the objectives of the study.
• Unsuitable veins for venipuncture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]Florbetapir; Participants will undergo amyloid PET imaging with an approved amyloid radiotracer (ie, [18F]Florbetapir (Amyvid™)) to assess β-amyloid neuritic plaque density.	Drug: Amyvid; All participants will undergo a single β-amyloid PET scan with Amyvid.; Other Names: [18F]Florbetapir

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Invicro
• Investigators: Principal Investigator: David Russell, Invicro

Publications and helpful links

Helpful Links

• Related Information

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: AD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: Plasma P-tau 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No