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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 | Clinical Trials | Clareo Health

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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

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

NCT02640092•Genentech, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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)
+1 more criteria

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)
•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)

Locations (16)

Molecular NeuroImaging

New Haven, Connecticut, United States

KI Health Partners, LLC; New England Institute for Clinical Research

Stamford, Connecticut, United States

Neuropsychiatric Research; Center of Southwest Florida

Fort Myers, Florida, United States

Miami Jewish Health Systems

Miami, Florida, United States

Bioclinica Research

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

NeuroStudies.net, LLC

Decatur, Georgia, United States

Acadia Clinical Research; Dr. Henderson's Office

Bangor, Maine, United States

Donald S. Marks, M.D., P.C.; Medical Center

Plymouth, Massachusetts, United States

Alzheimers Disease Center

Quincy, Massachusetts, United States

Key Dates

Start Date

December 23, 2015

Primary Completion Date

June 11, 2019

Completion Date

June 11, 2019

Last Updated

December 23, 2019

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

[18F]GTP1

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia