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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-13

Study Completion Date

2014-05-30

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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Healthy Volunteer Subjects

Healthy males or females 50 years or older with no evidence of cognitive impairment

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan

Intervention Type PROCEDURE

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

MCI subjects

Subjects 50 years or older with mild cognitive impairment (MCI)

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan

Intervention Type PROCEDURE

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

Probable AD Subjects

Subjects 50 years or older with probable Alzheimer's Disease (AD)

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Brain PET scan

Intervention Type PROCEDURE

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

Interventions

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Flortaucipir F18

IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Intervention Type DRUG

Brain PET scan

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

Intervention Type PROCEDURE

Other Intervention Names

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[F18]T807 18F-AV-1451 Tauvid

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes