Plasma P-tau2017 and Quantitative Amyloid PET Imaging

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

Detailed Description
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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.

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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: Amyvid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AD