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Initial Investigation of [18F]P16-129 in Alzheimer's Disease Patients and Healthy Volunteers

NCT03902548 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-07-20

No results posted yet for this study

Summary

This study investigates the initial safety profile of \[18F\]P16-129 in healthy volunteers including dosimetry determination, and compares the uptake and kinetics of \[18F\]P16-129 with the FDA approved drug \[18F\]florbetapir in the brains of Alzheimer's disease patients.

Conditions

  • Alzheimer Disease

Interventions

DRUG

[18F]P16-129

Injection of \< 10 mCi \[18F\]P16-129 followed by PET/CT scanning

Sponsors & Collaborators

  • Five Eleven Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2019-11-02
Completion
2019-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03902548 on ClinicalTrials.gov