Plasma P-tau2017 and Quantitative Amyloid PET Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2022-11-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Positron Emission Tomography of Amyloid in Alzheimer's Disease

NCT00205621

Alzheimer's Disease

SUSPENDED PHASE1

Safety and Efficacy of Positron Emission Tomography Imaging With MNI-513

NCT01000870

Alzheimer Disease

TERMINATED EARLY_PHASE1

PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620

NCT05456503

Frontotemporal Lobar Degeneration Alzheimer Disease Cognitively Normal

RECRUITING PHASE3

PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers

NCT01826110

Alzheimer's Disease

COMPLETED PHASE1

Imaging of Brain Amyloid Plaques in the Aging Population

NCT00950430

Alzheimer's Disease Dementia With Lewy Bodies Frontotemporal Dementia +1 more

ENROLLING_BY_INVITATION PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

[18F]Florbetapir

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

Group Type EXPERIMENTAL

Amyvid

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amyvid

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

[18F]Florbetapir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes