Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:3/22/2019
Start Date:December 23, 2015
End Date:May 31, 2019

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Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Patients With Prodromal, Mild, and Moderate Alzheimer's Disease Compared to Healthy Volunteers

This is an open-label, longitudinal observational study evaluating the imaging
characteristics of the tau positron-emission tomography (PET) radioligand [18F] Genentech Tau
Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's
disease (AD) compared to healthy participants. The overall goal of this protocol is to
evaluate the longitudinal change in tau burden using [18F]GTP1, a tau targeted
radiopharmaceutical.


Inclusion Criteria:

For All Participants:

- Availability of a study partner who, in the investigator's judgment, has frequent and
sufficient contact with the participant and is able to provide accurate information
regarding the participant's cognitive and functional abilities, agrees to accompany the
participant and provide information at visits

For Healthy Participants:

- Healthy with no clinically relevant finding on physical examination at screening and
upon reporting for the Baseline [18F]GTP1 imaging visit

- Have no cognitive complaint

- Have a Clinical Dementia Rating Scale (CDR) global score = 0

- Have a Mini-Mental State Examination (MMSE) score of 28-30

For Participants With a Diagnosis of AD:

- Participants with mild or moderate AD must meet National Institute on Aging -
Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia, with
an amnestic presentation

- Participants with prodromal AD must meet NIA-AA core clinical criteria for mild
cognitive impairment (MCI)

- Have screening [18F]florbetapir PET imaging demonstrating amyloid binding based on
qualitative visual read

- A brain MRI consistent with a diagnosis of AD, with no evidence of non-AD disease to
account for dementia or MRI exclusion criteria

- Medications taken for symptomatic treatment of AD must remain stable for at least 30
days prior to screening visit

- Satisfy one of the following subgroups: Approximately 20 prodromal AD (MMSE 24-30, CDR
= 0.5); Approximately 20 mild AD (MMSE 22-30, CDR = 0.5 or 1); Approximately 20
moderate AD (MMSE 16-21, CDR = 0.5 or 1 or 2)

Exclusion Criteria:

- Current or prior history of any drug or alcohol abuse

- Participants with any significant psychiatric, neurological, or unstable medical
disorder expected to interfere with the study

- Participants unable to undergo MRI and PET scan

- For participants contributing CSF samples, any contraindication to lumbar puncture

- Prior participation in other research protocols or clinical care in the last year such
a radiation exposure combined with that from the present study exceeds an effective
dose of 50 millisievert (mSV), the allowable annual limit for research participants as
stipulated by the Food and Drug Administration (FDA)
We found this trial at
16
sites
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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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Allentown, Pennsylvania 18104
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792 Stillwater Avenue
Bangor, Maine 04401
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Decatur, Georgia 30033
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East Providence, Rhode Island 02914
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Fort Myers, FL
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4730 West Bancroft Street
Maumee, Ohio 43537
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Miami, Florida 33137
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Mount Arlington, New Jersey 07856
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New Haven, Connecticut
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100 West Gore Street
Orlando, Florida 32806
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45 Resnik Road
Plymouth, Massachusetts 02360
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Quincy, Massachusetts 02169
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Toms River, New Jersey 08755
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