Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer Disease (AD)
• Interventions: Drug: [18F]GTP1; Drug: [18F]MK-6240; Drug: [18F]PI-2620

• Registration Number: NCT04566003
• Lead Sponsor: Genentech, Inc.

Brief Summary

The study aims to compare tau targeted radiotracers \[18F\]GTP1 and \[18F\]PI-2620 or \[18F\]MK-6240 in subjects with normal cognition or prodromal to moderate Alzheimer's disease (AD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Study Start: 2020-10-26
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
[18F]GTP1 PET, then [18F]MK-6240	[18F]GTP1	Participants will undergo one \[18F\]GTP1 PET imaging session, then one \[18F\]MK-6240 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of \[18 F\]MK-6240 or 7mCi of \[18F\]GTP1.
[18F]GTP1 PET, then [18F]MK-6240	[18F]MK-6240	Participants will undergo one \[18F\]GTP1 PET imaging session, then one \[18F\]MK-6240 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of \[18 F\]MK-6240 or 7mCi of \[18F\]GTP1.
[18F]PI-2620 PET, then [18F]GTP1 PET	[18F]PI-2620	Participants will undergo one \[18F\]PI-2620 PET imaging session, then one \[18F\]GTP1 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of \[18F\]PI-2620 or 7mCi of \[18F\]GTP1.
[18F]PI-2620 PET, then [18F]GTP1 PET	[18F]GTP1	Participants will undergo one \[18F\]PI-2620 PET imaging session, then one \[18F\]GTP1 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of \[18F\]PI-2620 or 7mCi of \[18F\]GTP1.

Primary Outcome Measures

Name	Time	Method
Brain tau burden as measured by [18F]PI-2620 - PET	Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]GTP1 - PET	Approximately 1 hour after injection of [18F]PI-2620
Brain tau burden as measured by [18F]MK-6240 - PET	Approximately 1 hour after injection of [18F]MK-6240
Percentage of Participants with Adverse Events (AEs)	Up to approximately 4 days after administration of each radiotracer

Trial Locations

Locations (1)

Invicro, a Konica Minolta company; 🇺🇸 New Haven, Connecticut, United States