A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
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ClinicalTrials.gov Identifier: NCT01992380 |
Recruitment Status :
Completed
First Posted : November 25, 2013
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: Flortaucipir F18 Procedure: Brain PET scan | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects. |
Actual Study Start Date : | November 13, 2013 |
Actual Primary Completion Date : | May 30, 2014 |
Actual Study Completion Date : | May 30, 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Healthy Volunteer Subjects
Healthy males or females 50 years or older with no evidence of cognitive impairment
|
Drug: Flortaucipir F18
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Other Names:
Procedure: Brain PET scan positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection |
Experimental: MCI subjects
Subjects 50 years or older with mild cognitive impairment (MCI)
|
Drug: Flortaucipir F18
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Other Names:
Procedure: Brain PET scan positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection |
Experimental: Probable AD Subjects
Subjects 50 years or older with probable Alzheimer's Disease (AD)
|
Drug: Flortaucipir F18
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Other Names:
Procedure: Brain PET scan positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection |
- Test-Retest Reproducibility [ Time Frame: 80-100 minutes postdose ]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
- Test-Retest Reproducibility [ Time Frame: 110-130 minutes postdose ]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

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
Healthy Volunteers
- Male or female subjects ≥ 50 years of age
- Mini-mental state examination (MMSE) ≥ 29
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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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992380
United States, California | |
Research Site | |
Newport Beach, California, United States, 92663 | |
United States, Connecticut | |
Research Site | |
New Haven, Connecticut, United States, 06510 |
Study Chair: | Chief Medical Officer | Avid Radiopharmaceuticals, Inc. |
Responsible Party: | Avid Radiopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01992380 |
Other Study ID Numbers: |
18F-AV-1451-A03 |
First Posted: | November 25, 2013 Key Record Dates |
Results First Posted: | September 7, 2020 |
Last Update Posted: | September 7, 2020 |
Last Verified: | August 2020 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |