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

NCT04566003 | Completed Phase 1 FDA Drug

• 1 other identifier: GN42801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer Disease (AD)

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants with Adverse Events (AEs)

  Up to approximately 4 days after administration of each radiotracer

• 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

Study Arms (2)

[18F]PI-2620 PET, then [18F]GTP1 PET

EXPERIMENTAL

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.

Drug: [18F]GTP1; Drug: [18F]PI-2620

[18F]GTP1 PET, then [18F]MK-6240

EXPERIMENTAL

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.

Drug: [18F]GTP1; Drug: [18F]MK-6240

Interventions

[18F]GTP1 DRUG

Participants will receive a bolus IV of approximately 7mCi of \[18F\]GTP1 radiotracer.

[18F]GTP1 PET, then [18F]MK-6240; [18F]PI-2620 PET, then [18F]GTP1 PET

[18F]PI-2620 DRUG

Participants will receive a bolus IV of approximately 5mCi of \[18F\]PI-2620 radiotracer.

[18F]PI-2620 PET, then [18F]GTP1 PET

[18F]MK-6240 DRUG

Participants will receive a bolus IV of approximately 5mCi of \[18F\]MK-6240 radiotracer.

[18F]GTP1 PET, then [18F]MK-6240

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitively normal subjects aged 65 to 90 years and prodromal to mild AD subjects aged 50 to 90 years, inclusive at the time of screening.
• Prodromal to moderate AD subjects: Meet the National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment (MCI) due to AD, probable AD dementia or AD dementia
• Have a Clinical Dementia Rating (CDR) score of 0 (cognitively normal) or 0.5 (prodromal to moderate AD) at screening
• Have an Mini-Mental State Examination (MMSE) score 10-30 inclusive
• Have Aβ PET imaging demonstrating Aβ binding based on qualitative visual read at screening or using an acceptable historical PET scan (cognitively normal subjects will be assessed with Aβ PET at screening but will not be required to demonstrate Aβ binding).
• A brain MRI consistent with normal cognition or that supports a diagnosis of prodromal to moderate AD, with no evidence of other significant neurologic pathology. A previously acquired research MRI within the last 12 months may be used if deemed acceptable by the investigator and no significant clinically relevant changes have occurred since the prior MRI was obtained
• The subject has an appropriate study partner capable of participating in CDR assessment and, if necessary, of accompanying the subject
• For cognitively normal subjects only: History of at least one first degree relative with diagnosis of Alzheimer's disease (self-reported by the potential subject and/or confirmed by the study partner).

You may not qualify if:

• Current or prior history of any alcohol or drug abuse within the last 2 years
• Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 millisievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease
• MRI evidence of cerebrovascular disease, infectious disease, space-occupying lesions, normal pressure hydrocephalus, or other central nervous system (CNS) disease
• Implants that have not been certified for MRI or history of claustrophobia in MRI, unless an acceptable previously acquired research MRI is available

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Invicro, a Konica Minolta company

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

(18F)GTP1; ((18)F)PI-2620

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: October 26, 2020
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)