Plasma P-tau2017 and Quantitative Amyloid PET Imaging

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164536
• Other study ID #: Plasma P-tau 2017
• Status: Recruiting
• Phase: Phase 1
• Start date: August 27, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2021
• Source: Invicro
• Contact: Lianne Ramia
• Phone: 203-401-4300
• Email: recruitment[@]invicro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Amyvid
All participants will undergo a single ß-amyloid PET scan with Amyvid.

Locations

Country	Name	City	State
United States	Invicro	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Invicro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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