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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Flortaucipir F18
* Procedure: Brain PET scan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteer Subjects<br>Healthy males or females 50 years or older with no evidence of cognitive impairment | Drug: Flortaucipir F18<br>* IV injection, 370 MBq (10 mCi), two doses up to four weeks apart<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection<br>|
| Experimental: MCI subjects<br>Subjects 50 years or older with mild cognitive impairment (MCI) | Drug: Flortaucipir F18<br>* IV injection, 370 MBq (10 mCi), two doses up to four weeks apart<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection<br>|
| Experimental: Probable AD Subjects<br>Subjects 50 years or older with probable Alzheimer's Disease (AD) | Drug: Flortaucipir F18<br>* IV injection, 370 MBq (10 mCi), two doses up to four weeks apart<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |