Plasma P-tau2017 and Quantitative Amyloid PET Imaging
Primary Purpose
Alzheimer Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amyvid
Sponsored by
About this trial
This is an interventional other trial for Alzheimer Disease focused on measuring AD
Eligibility Criteria
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.
Sites / Locations
- InvicroRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]Florbetapir
Arm Description
Participants will undergo amyloid PET imaging with an approved amyloid radiotracer (ie, [18F]Florbetapir (Amyvid™)) to assess β-amyloid neuritic plaque density.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05164536
Brief Title
Plasma P-tau2017 and Quantitative Amyloid PET Imaging
Official Title
Plasma P-tau2017 and Quantitative Amyloid PET Imaging in a Cognitively Normal Population
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invicro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
AD
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[18F]Florbetapir
Arm Type
Experimental
Arm Description
Participants will undergo amyloid PET imaging with an approved amyloid radiotracer (ie, [18F]Florbetapir (Amyvid™)) to assess β-amyloid neuritic plaque density.
Intervention Type
Drug
Intervention Name(s)
Amyvid
Other Intervention Name(s)
[18F]Florbetapir
Intervention Description
All participants will undergo a single β-amyloid PET scan with Amyvid.
Primary Outcome Measure Information:
Title
Creation of a database of brain amyloid deposition by region using PET signal-to-noise ratio, SUVr .
Description
Amyloid PET imaging will be used to measure regional brain amyloid deposition in each subject.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Creation of a database of blood P-tau217 and other blood biomarkers.
Description
Blood will be analyzed at Eli Lilly for P-tau217 and ApoE genotype. The analysis will be described in a separate analysis plan.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lianne Ramia
Phone
203-401-4300
Email
recruitment@invicro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Russell
Organizational Affiliation
Invicro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Invicro
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Russell, M.D., Ph.D
Phone
203-401-4300
First Name & Middle Initial & Last Name & Degree
David Russell, MD, PhD
First Name & Middle Initial & Last Name & Degree
Joyce Gibbons, PA-C
First Name & Middle Initial & Last Name & Degree
Amy Knorr, MD
12. IPD Sharing Statement
Links:
URL
http://invicro.com
Description
Related Information
Learn more about this trial
Plasma P-tau2017 and Quantitative Amyloid PET Imaging
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