Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI and AD Subjects



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:20 - Any
Updated:10/27/2018
Start Date:December 2013
End Date:July 28, 2017

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An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease

This is a cross-sectional and longitudinal study that will evaluate imaging characteristics
of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and
Alzheimer's disease (AD) subjects.


Inclusion Criteria:

Exploratory Cognitively Healthy Subjects

- ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age

- Mini-mental state examination (MMSE) ≥ 29

- No significant history of cognitive impairment

Exploratory MCI 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

Exploratory AD Subjects

- ≥ 50 years of age

- MMSE > 10

- Have possible or 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

Confirmatory Subjects

- ≥ 50 years of age

- MMSE ≥ 20 and ≤ 27

- Cognitively impaired subjects with either MCI or dementia with a suspected
neurodegenerative cause

- 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

- History of moderate or severe traumatic brain injury

- 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.
We found this trial at
27
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One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Deerfield Beach, Florida 33064
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fort Myers, Florida 33907
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Irvine, California 92868
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Las Vegas, Nevada 89113
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New Haven, Connecticut
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Newport Beach, California 92663
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Orlando, Florida 32806
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85006
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345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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Quincy, Massachusetts 02169
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Sacramento, California 95816
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Sacramento, California 95817
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Saint Louis, Missouri 63110
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Saint Petersburg, Florida 33709
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50 Beale Street
San Francisco, California 94121
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Santa Monica, California 90404
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Scottsdale, Arizona 85258
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Scottsdale, Arizona 85259
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Sun City, Arizona 85351
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Tampa, Florida 33613
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West Palm Beach, Florida 33407
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