A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects

Alzheimer's Disease Clinical Trial

Official title:

Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992380
• Other study ID #: 18F-AV-1451-A03
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2013
• Est. completion date: May 30, 2014

Study information

• Verified date: August 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2014
• Est. primary completion date: May 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Healthy Volunteers

• Male or female subjects = 50 years of age

• Mini-mental state examination (MMSE) = 29

• MCI Subjects

• Male or female subjects = 50 years of age

• MMSE = 24

• Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD

• Have a study partner that can report on subject's activities of daily living

• Probable AD Subjects

• Male or female subjects = 50 years of age

• MMSE > 10

• Meet clinical criteria for probable AD based on the NIA-AA working group's diagnostic guidelines for AD

• Have a study partner that can report on subject's activities of daily living

Exclusion Criteria:

• Current clinically significant psychiatric disease

• Evidence of structural brain abnormalities

• Evidence of dementing illness other than AD

• Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes

• Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer

• History of alcohol or substance abuse or dependence

• Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception

• Have received or participated in a trial with investigational medications in the past 30 days

• have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Flortaucipir F18
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Procedure:
• Brain PET scan
positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection

Locations

Country	Name	City	State
United States	Research Site	New Haven	Connecticut
United States	Research Site	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Devous MD Sr, Joshi AD, Navitsky M, Southekal S, Pontecorvo MJ, Shen H, Lu M, Shankle WR, Seibyl JP, Marek K, Mintun MA. Test-Retest Reproducibility for the Tau PET Imaging Agent Flortaucipir F 18. J Nucl Med. 2018 Jun;59(6):937-943. doi: 10.2967/jnumed.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-Retest Reproducibility	Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects	80-100 minutes postdose
Primary	Test-Retest Reproducibility	Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects	110-130 minutes postdose