Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

NCT04468347 | Completed Phase 1 Results

• 1 other identifier: 18F-AV-1451-A08
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Flortaucipir PET Imaging (Quantitative)

  Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

  baseline scan

• Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status

  Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B (\[C-11\] PiB) PET results available from the parent AIBL study.

  baseline scan

• Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status

  Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced \[τAD++\] and Moderate \[τAD+\] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B (\[C-11\] PiB) PET results available from the parent AIBL study.

  baseline scan

Study Arms (4)

Alzheimer's disease (AD)

EXPERIMENTAL

Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months

Drug: Flortaucipir F18; Procedure: Brain PET scan

Mild cognitive impairment (MCI)

EXPERIMENTAL

Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months

Drug: Flortaucipir F18; Procedure: Brain PET scan

Subjective memory complainers (SMC)

EXPERIMENTAL

Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months

Drug: Flortaucipir F18; Procedure: Brain PET scan

Cognitively normal (CN)

EXPERIMENTAL

Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months

Drug: Flortaucipir F18; Procedure: Brain PET scan

Interventions

Flortaucipir F18 DRUG

IV injection, 240 megabecquerel (MBq) (6.5 mCi)

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

Alzheimer's disease (AD); Cognitively normal (CN); Mild cognitive impairment (MCI); Subjective memory complainers (SMC)

Brain PET scan PROCEDURE

positron emission tomography (PET) scan of the brain

Alzheimer's disease (AD); Cognitively normal (CN); Mild cognitive impairment (MCI); Subjective memory complainers (SMC)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms

You may not qualify if:

• lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
• history of electroconvulsive therapy
• MRI contraindicated
• claustrophobic or, otherwise, unable to tolerate the imaging procedure
• current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
• history of additional risk factors for Torsades de Pointes
• current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
• history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
• current drug or alcohol abuse/dependence
• history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
• females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Related Links

• Link to the Australian Imaging, Biomarker \& Lifestyle Flagship Study of Ageing (AIBL) website

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: 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 13, 2020
• Study Start: October 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09