Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects

NCT04474405 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 18F-AV-1451-A01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Brain Flortaucipir Uptake

  Brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVr), normalized to the entire cerebellum. A global cortical average volume of interest (VOI) is the average SUVr of the occipital cortex, parietal cortex, and temporal cortex. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

  80-100 minutes postdose

• Flortaucipir Whole Body Effective Dose

  Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model.

  injection to 6 hours postdose

Secondary Outcomes (3)

• Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam)

  at baseline

• Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test)

  at baseline

• Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale)

  at baseline

Study Arms (3)

Brain flortaucipir PET scan

EXPERIMENTAL

Subjects receiving a brain PET scan after flortaucipir administration

Drug: Flortaucipir F18; Procedure: Brain PET Scan; Drug: Florbetapir F 18; Procedure: Brain MRI

Whole body flortaucipir PET scan

EXPERIMENTAL

Subjects receiving a whole body PET scan after flortaucipir administration

Drug: Flortaucipir F18; Procedure: Whole body PET scan

MRI and Amyloid Extension Cohort

OTHER

Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355)

Procedure: Brain PET Scan; Drug: Florbetapir F 18; Procedure: Brain MRI

Interventions

Flortaucipir F18 DRUG

IV injection, 370 MBq (10 mCi), single dose

Also known as: 18F-AV-1451, [F-18]T807, LY3191748, Tauvid

Brain flortaucipir PET scan; Whole body flortaucipir PET scan

Brain PET Scan PROCEDURE

positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).

Brain flortaucipir PET scan; MRI and Amyloid Extension Cohort

Whole body PET scan PROCEDURE

positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours

Whole body flortaucipir PET scan

Florbetapir F 18 DRUG

IV injection, 370 MBq (10 mCi), single dose

Also known as: Amyvid

Brain flortaucipir PET scan; MRI and Amyloid Extension Cohort

Brain MRI PROCEDURE

Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain

Brain flortaucipir PET scan; MRI and Amyloid Extension Cohort

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;
• MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
• Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)

You may not qualify if:

• Current clinically significant psychiatric disease.
• Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
• Claustrophobic or otherwise unable to tolerate the imaging procedure.
• Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval \>450 msec).
• Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
• History of alcohol abuse or substance abuse or dependence
• Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
• Required medications with a narrow therapeutic window
• Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session
• Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (2)

WCCT Global, LLC

Cypress, California, 90630, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole; florbetapir

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Medical Director

  Avid Radiopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 16, 2020
• Study Start: August 16, 2013
• Primary Completion: December 9, 2013
• Study Completion: December 9, 2013
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Locations

US (2)