Plasma P-tau2017 and Quantitative Amyloid PET Imaging

NCT05164536 | Completed Phase 1 FDA Drug

• 1 other identifier: Plasma P-tau 2017
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Keywords

AD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Creation of a database of blood P-tau217 and other blood biomarkers.

  1 year

Study Arms (1)

[18F]Florbetapir

EXPERIMENTAL

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

Drug: Amyvid

Interventions

Amyvid DRUG

All participants will undergo a single β-amyloid PET scan with Amyvid.

Also known as: [18F]Florbetapir

[18F]Florbetapir

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invicro: lead

Study Sites (1)

Invicro

New Haven, Connecticut, 06510, United States

Location

Related Links

• Related Information

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Russell

  Invicro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 20, 2021
• Study Start: August 27, 2021
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: February 28, 2025

Record last verified: 2023-02

Locations

US (1)